HR+/HER2- Locally Advanced, Metastatic Breast CancerROISNCT03921866
UK Ibrance Patient Program (IPP) Study
An observational study of HR+/HER2- Locally Advanced, Metastatic Breast Cancer, run by Pfizer at 8 sites in United Kingdom.
Trial summary
What are the real-world treatment patterns, patients' characteristics, clinical outcomes and healthcare resource utilisation associated with palbociclib treatment in the 3 years following initiation in United Kingdom patients with hormone receptor-positive, human epidermal growth factor 2-negative metastatic breast… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- HR+/HER2- Locally Advanced, Metastatic Breast Cancer
- What is being tested?
- Palbociclib
- How many people
- 191 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 1 Mar 2019to 4 Mar 2021
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women over the age of 18 who entered into the UK IPP
Who may be able to join
- All patients meeting the following eligibility criteria will be included in the study:
- Patients enrolled into the IPP at one of the selected hospitals (see Annex 1 for IPP enrolment letter).
- Patients who received ≥1 dose of palbociclib as part of the IPP at one of the selected sites.
- For sites where data collection is performed by pH Associates, written informed consent will be required from living patients to access their medical records.
- Patient aged ≥18 years old at enrollment into the IPP
Who cannot join
None listed.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Brighton Sussex Cancer Centre
Brighton, BN2 5BB
Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Guys and St Thomas' NHS Trust
London, SE1 9RT
Maidstone Hospital
Maidstone, ME16 9QQ
The Christie NHS Foundation Trust
Manchester, M20 4BX
Clatterbridge
Metropolitan Borough of Wirral, CH63 4JY
Newcastle Freeman Hospital
Newcastle upon Tyne, NE7 7DN
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LQ
About this study
Official title: Observational Cohort Study of Patients With Hormone Receptor-positive Metastatic Breast Cancer Treated With Palbociclib (Ibrance(Registered)) as Part of the United Kingdom Ibrance (Registered) Patient Program (IPP); the Real Outcomes Ibrance (Registered) Study (ROIS)
What are the real-world treatment patterns, patients' characteristics, clinical outcomes and healthcare resource utilisation associated with palbociclib treatment in the 3 years following initiation in United Kingdom patients with hormone receptor-positive, human epidermal growth factor 2-negative metastatic breast cancer treated as part of the IPP?
Read the detailed description
Hormone receptor positive (HR+) breast cancer (BC) represents the largest therapeutic subtype of the disease, accounting for 60 to 65% of all malignant neoplasms of the breast. Palbociclib (Ibrance®) is a small-molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6) which in clinical trial settings has been shown to increase progression-free survival (PFS) for patients with HR+, human epidermal growth factor 2-negative (HER2-) metastatic breast cancer (MBC). Palbociclib first received a European Union (EU) marketing authorisation in September 2016, to be commercialised as Ibrance® by Pfizer. Palbociclib was recommended for use with an aromatase inhibitor in patients with HR+/HER2- locally advanced and MBC in the National Health Service (NHS) in England by the National Institute for Health and Care Excellence (NICE) in November 2017 and by the Scottish Medicines Consortium (SMC) in December 2017. In order to provide access to palbociclib in the United Kingdom (UK) during the NICE/SMC appraisal period, the Ibrance® Patient Program (IPP) was initiated and run by Pfizer between April 2017 until a positive NICE/SMC appraisal in November 2017 (for England and Wales) or December 2017 (for Scotland).
Pfizer are interested in the opportunity to collect data from patients who received palbociclib as part of the UK IPP, to better understand patients' characteristics in a routine care setting, treatment persistence and dose management, clinical outcomes, and healthcare resource utilisation. This study will provide real-world evidence on patients' clinical progression and experience of treatment with palbociclib in routine clinical settings in a UK context.
Research question:
What are the real-world treatment patterns, patients' characteristics, clinical outcomes and healthcare resource utilisation associated with palbociclib treatment in the 3 years following initiation in United Kingdom patients with HR+/HER2- MBC treated as part of the IPP?
- Being tested
- Palbociclib
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PalbociclibDrug
Palbociclib
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants According to Treatment Lines
Percentage of participants according to treatment lines during anytime between breast cancer (BC) diagnosis and index date were reported in this outcome measure. Treatment lines included: 1) 1st line where, palbociclib was prescribed as the first line treatment for MBC, 2) 1st line palbociclib added to letrozole where, palbociclib was prescribed as the first line treatment along with ongoing letrozole treatment which was prescribed more than 3 months prior to initiation of palbociclib, 3) 2nd line where palbociclib was prescribed as the second or later treatment line for MBC.
Measured: At baseline
Time From Letrozole to Palbociclib Initiation
Time from letrozole was defined as duration from the start date of letrozole which was ongoing at the time of palbociclib treatment initiation up to the index date.
Measured: At baseline
Number of Participants With Menopausal Status
Number of participants with menopausal status as pre-menopausal, peri-menopausal, post-menopausal and not applicable (NA), during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Percentage of Participants According to Disease Free Interval at Palbociclib Initiation
Disease free interval was defined as the time from the date of last known neo-adjuvant hormone therapy to the date of MBC diagnosis.
Measured: At baseline
Percentage of Participants With Primary or Recurrent Metastatic Breast Cancer Diagnosis
Percentage of participants with de novo and recurrent metastatic disease, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Percentage of Participants With Lymph Nodes Involvement
Percentage of participants with lymph nodes involvement during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Data for this outcome measure is also presented by de novo status.
Measured: At baseline
Number of Lymph Nodes Involved
Number of lymph nodes involved during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Data for this outcome measure is also presented by de novo status.
Measured: At baseline
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status
Number of participants with estrogen, progesterone and HER2 receptor status during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Percentage of Participants Who Had Rebiopsy After Metastatic Disease Diagnosis
Percentage of participants who had rebiopsy during anytime between MBC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Percentage of Participants According to Tumor Stage
Percentage of participants with tumor stages 0, 1, 2, 3 and 4, as per Tumor, Node, Metastasis (TNM) staging system, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. As per TNM staging system, tumor stage 0 indicates main tumor cannot be found; tumor stages 1, 2, 3 and 4 refers to the size and/or extent of the main tumor. The higher the number, the larger the tumor and/or the more it has spread into nearby tissues. Data for this outcome measure is also presented by de novo status.
Measured: At baseline
Percentage of Participants According to Nodal Status
Percentage of participants with nodal stages 0, 1, 2 and 3, as per TNM staging system, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. As per TNM staging system, nodal stage 0 indicates no cancer in regional lymph nodes; nodal stages 1= cancer has spread to 1 to 3 lymph nodes; nodal stage 2= cancer has spread to 4 to 9 lymph nodes, nodal stage 3= indicates the cancer has spread to 10 or more lymph nodes. Data for this outcome measure is also presented by de novo status.
Measured: At baseline
Percentage of Participants According to Metastasis
Percentage of participants with metastasis stages 0 and 1, as per TNM staging system, during anytime between MBC disease diagnosis and index date were reported in this outcome measure. As per TNM staging system, metastasis stage 0 indicates cancer has not spread to other parts of the body; metastasis stage 1 indicates that the cancer has spread to distant parts of the body. Data for this outcome measure is also presented by de novo status.
Measured: At baseline
Tumor Size at Palbociclib Initiation
Measured: At baseline
Percentage of Participants According to Tumor Grade
Percentage of participants with tumor grades, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Grades of disease was classified as grades 1, 2 and 3. As per TNM system, grade 1= well differentiated cells, low grade; grade 2= moderately differentiated cells, intermediate grade and grade 3= poorly differentiated cells, high grade.
Measured: At baseline
Percentage of Participants With Ki-67 Protein Proliferation Index Recorded
Percentage of participants with Ki-67 protein proliferation index during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. The Ki-67 protein is a cellular marker for proliferation. Ki-67 is a protein in cells that increases as cells prepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. More positive cells hasten in dividing and forming new cells. Proliferation index was measured by the percentage of cells staining for Ki-67.
Measured: At baseline
Ki-67 Protein Proliferation Index
The Ki-67 protein is a cellular marker for proliferation. Ki-67 is a protein in cells that increases as cells prepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. More positive cells hasten in dividing and forming new cells. Proliferation index was measured by the percentage of cells staining for Ki-67.
Measured: At baseline
Percentage of Participants With Eastern Cooperative Oncology Group Performance Score (ECOG PS)
ECOG PS measured quality of life of cancer participants on a 0 to 5 scale; 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity, ambulatory, able to carry out light/sedentary work; 2= ambulatory, capable of all self-care, unable to carry out any work activity, up >50 % of waking hours; 3= capable of only limited self-care, confined to bed/ chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead. Higher scores indicated worsening of quality of life.
Measured: At baseline
Percentage of Participants With Recurrence Type
Percentage of participants with recurrence type during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Percentage of Participants According to Number of Metastatic Sites
Percentage of participants according to number of metastatic sites during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Percentage of Participants According to Location of Metastases
Percentage of participants according to location of metastases, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Percentage of Participants With Non-Visceral Location of Metastases
Percentage of participants with non-visceral location of metastases, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Number of Participants According to Metastatic Sites With Locoregional Recurrence
Number of participants according to metastatic sites with locoregional recurrence, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Metastatic sites with locoregional recurrence included bone, breast, lung, pleural, regional lymph nodes and other sites.
Measured: At baseline
Duration of Disease at Initiation of Palbociclib
Duration of BC disease was the time duration between date of BC disease diagnosis to palbociclib treatment initiation date.
Measured: At baseline
Percentage of Participants Who Received Chemotherapy in Adjuvant or Neoadjuvant Setting
Percentage of participants who received chemotherapy in adjuvant or neoadjuvant setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Percentage of Participants Who Received Chemotherapy in Advanced, Disease Modifying or Metastatic Setting
Percentage of participants who received chemotherapy in advanced, disease modifying or metastatic setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Number of Lines of Prior Chemotherapy for Metastatic Disease
Number of lines of prior chemotherapy for metastatic disease during anytime between MBC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Percentage of Participants Who Received Luteinizing Hormone Releasing Hormone (LHRH) or Chemotherapy
Percentage of participants who received LHRH or chemotherapy, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Percentage of Participants Who Received Endocrine Therapy in Adjuvant or Neoadjuvant Setting
Percentage of participants who received endocrine therapy in adjuvant or neoadjuvant setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Number of Participants With Types of Endocrine Therapy in Adjuvant or Neoadjuvant Setting
Number of participants with types of endocrine therapy in adjuvant or neoadjuvant setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Percentage of Participants Who Received Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting
Percentage of participants who received endocrine therapy in advanced, disease modifying or metastatic setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Percentage of Participants With Type of Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting
Percentage of participants with type of endocrine therapy in advanced, disease modifying or metastatic setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Number of Lines of Prior Endocrine Therapy for Metastatic Disease
Number of lines of prior endocrine therapy for metastatic disease during anytime between MBC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Number of Participants Who Received Radiotherapy in Advanced, Disease Modifying or Metastatic Setting
Number of participants who received radiotherapy in advanced, disease modifying or metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Percentage of Participants Who Received Concomitant Medications
Percentage of participants who received concomitant medications, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Number of Participants With Concomitant Medications Prescribed Along With Goserelin
Number of participants with concomitant medications prescribed along with goserelin, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Goserelin is the generic drug with a brand name Zoladex.
Measured: At baseline
Number of Participants According to Number of Prior Treatments in Metastatic Setting
Number of participants according to number of prior treatments in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Number of Participants According to Number of Prior Chemotherapy and Hormone Therapy in Metastatic Setting
Number of participants according to number of prior chemotherapy and hormone therapy in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Number of Participants According to Number of Prior Chemotherapies in Metastatic Setting
Number of participants according to number of prior chemotherapies in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Number of Participants According to Number of Prior Hormone Therapies in Metastatic Setting
Number of participants according to number of prior hormone therapies in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.
Measured: At baseline
Secondary outcomes (51)
Percentage of Participants With Their Starting Dose of Palbociclib
Percentage of participants with their starting dose of palbociclib were reported.
Measured: Data collected at index date (for a maximum period of 3 years)
Percentage of Participants Who Received Endocrine Therapy Along With Palbociclib
Percentage of participants who received endocrine therapy along with palbociclib were reported in this outcome measure. Endocrine therapy includes anastrozole, exemestane, fulvestrant and letrozole.
Measured: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Percentage of Participants With Dose Reductions and Treatment Discontinuation
Percentage of participants with dose reductions and treatment discontinuation were reported in this outcome measure.
Measured: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Number of Participants With Reasons for Palbociclib Discontinuation
Number of participants with reasons for palbociclib discontinuation were reported in this outcome measure. Disease progression (PD) was defined as greater than or equal to (>=)20 percent (%) increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 millimeter (mm) or appearance of 1 or more new lesions. Adverse drug reactions (ADR) were defined as unintended, harmful events attributed to the use of drug. As per World Health Organisation (WHO) criteria for hematologic and nonhematologic toxicity grade 3 was defined as the severe/worst grade.
Measured: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Percentage of Participants With Temporary Discontinuation
Percentage of participants with temporary discontinuation of palbociclib were reported in this outcome measure.
Measured: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Percentage of Participants According to Time to Dose Reduction in First Line Therapy
Percentage of participants according to time to dose reduction after palbociclib initiation in 1st line therapy were reported in this outcome measure.
Measured: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Time to Palbociclib Discontinuation
Time to palbociclib discontinuation were observed in participants who permanently discontinued palbociclib and were reported in this outcome measure.
Measured: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Number of Participants With First 3 Lines of Treatment After Progression
Number of participants according to lines of treatment after progression were reported in this outcome measure.
Measured: Data collected from date of progression until lost to follow up or end of follow up period, whichever occurred first (for a maximum period of 3 years)
Doses Prescribed for First 3 Lines of Treatment After Progression
Doses of drugs prescribed for first 3 lines of treatment after progression were reported in this outcome measure.
Measured: Data collected from date of progression until lost to follow up or end of follow up period, whichever occurred first (for a maximum period of 3 years)
Duration of First 3 Lines of Treatment After Progression
Time duration of first 3 lines of treatment after progression up to lost to follow up or end of follow up period, whichever occurred first were reported in this outcome measure.
Measured: Data collected from date of progression until lost to follow up or end of follow up period, whichever occurred first (for a maximum period of 3 years)
Number of Completed Cycles of Palbociclib
Number of 28-day cycles completed for palbociclib treatment were reported in this outcome measure.
Measured: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Percentage of Participants Who Received Letrozole and Fulvestrant With Palbociclib
Percentage of participants who received letrozole and fulvestrant along with palbociclib were reported in this outcome measure.
Measured: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Percentage of Participants With Progression Free Survival Following Palbociclib Initiation
Progression free survival (PFS) was defined as the time from the index date to the date of first documented disease progression (PD) or death. PD was defined as >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Percentage of participants with progression free survival after index date were reported in this outcome measure.
Measured: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Percentage of Participants Alive Following Palbociclib Initiation
Percentage of participants who were alive after palbociclib initiation were reported in this outcome measure.
Measured: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Percentage of Participants With Partial Response (PR) and Complete Response (CR) Following Palbociclib Initiation
CR was defined as disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures less than (<)10 mm; PR was defined as >=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions.
Measured: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Percentage of Participants With Stable Disease (SD) Following Palbociclib Initiation
SD was defined as neither shrinkage for CR or PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. Alive participants with no events were censored at date of last response assessment. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures <10 mm; PR: >=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions.
Measured: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Progression Free Survival (PFS)
PFS was defined as the time from the index date to the date of first documented PD or death. PD was defined as at least a 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression.
Measured: From index date to PD or death whichever occurred first (for a maximum period of 3 years)
Overall Survival (OS)
OS was defined as the time between the index date and the date of death from any cause. Participants who were still alive at the last date of data collection were censored.
Measured: From index date until date of death or date of censoring (for a maximum period of 3 years)
Time to Achieving Best Overall Response (BOR)
Time to achieving BOR: time from index date until achievement of BOR: CR or PR, if CR was not achieved during follow-up. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures <10 mm; PR: >=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm. Appearance of 1 or more new lesions; Alive participants with no events were censored at date of last response assessment.
Measured: From index date till date of BOR or date of censoring (for a maximum period of 3 years)
Duration of Follow-up Period
Duration of follow-up period defined as the duration from index date until lost to follow up or end of follow up period, whichever occurred first, were reported in this outcome measure.
Measured: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Percentage of Participants With Best Response (BR), Progressive Disease (PD) and Stable Disease (SD) to Palbociclib
Percentage of participants with BR, PD and SD to palbociclib were reported in this outcome measure. BR was recorded for CR or PR. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures <10 mm; PR: >=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. SD: neither shrinkage for CR/PR nor increase for PD taking as reference smallest sum of longest diameters since treatment start. Alive participants with no events were censored at date of last response assessment.
Measured: From index date till BR (CR or PR, whichever occurred first), SD, PD or date of censoring (for a maximum period of 3 years)
Time to Best Response (BR)
Time to BR: time from index date until achievement of BR:CR or PR, if CR not achieved during follow-up. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures <10 mm; PR: >=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Alive participants with no events were censored at date of last response assessment. Data is also presented by de novo status and relapse status.
Measured: From index date till BR or date of censoring (for a maximum period of 3 years)
Time to First Response
Time to first response: time from index date until achievement of first response of CR or PR, if CR not achieved during follow-up. CR: disappearance of target, non-target lesions and normalization of tumor markers. Pathological lymph nodes had short axis measures <10 mm; PR: >=30% decrease in sum of measures (longest diameter for tumor lesions, short axis measure for nodes) of target lesions, taking reference baseline sum of diameters. Non-target lesions must be non-PD; PD: >=20% increase in sum of diameters of target lesions, taking as reference smallest sum on study, sum must demonstrate absolute increase of at least 5 mm or appearance of 1 or more new lesions. Alive participants with no events were censored at date of last response assessment. Data is also presented by de novo status and relapse status.
Measured: From index date till first documented CR or PR or date of censoring (for a maximum period of 3 years)
Percentage of Participants With Neutropenia Post-Palbociclib Initiation
Neutropenia is an abnormally low level of neutrophils with count <1500 neutrophils per microliter (mcL) in blood and was classified as per Common Toxicity Criteria (CTC) version 2.0 criteria: grade 1 (mild) with an absolute neutrophil count (ANC) of >=1500 to <2000 cells per mcL, grade 2 (moderate) with an ANC of >=1000 to <1500 cells per mcL, grade 3 (severe) with an ANC of >=500 to <1000 cells per mcL or grade 4 (severe) with an ANC lower than 500 cells per mcL. Percentage of participants with all grades, grade 3 and grade 4 were reported in this outcome measure. All grades category included grades 1 to grade 4.
Measured: Data collected from index date up to 6 months post-palbociclib initiation (for a maximum period of 3 years)
Percentage of Participants With Neutropenia Post-Palbociclib Initiation as Recorded and Inferred From Clinical Notes
Neutropenia is an abnormally low level of neutrophils with count <1500 neutrophils per mcL in blood and was classified as per CTC version 2.0 criteria: grade 1 (mild) with an ANC of >=1500 to <2000 cells per mcL, grade 2 (moderate) with an ANC of >=1000 to <1500 cells per mcL, grade 3 (severe) with an ANC of >=500 to <1000 cells per mcL or grade 4 (severe) with an ANC lower than 500 cells per mcL.
Measured: Data collected from index date up to 6 months post-palbociclib initiation (for a maximum period of 3 years)
Percentage of Participants With Neutropenia Post-Palbociclib Initiation as Recorded and Inferred From ANC Measurements
Neutropenia is an abnormally low level of neutrophils with count <1500 neutrophils per mcL in blood and was classified as per CTC version 2.0 criteria: grade 1 (mild) with an ANC of >=1500 to <2000 cells per mcL, grade 2 (moderate) with an ANC of >=1000 to <1500 cells per mcL, grade 3 (severe) with an ANC of >=500 to <1000 cells per mcL or grade 4 (severe) with an ANC lower than 500 cells per mcL.
Measured: Data collected from index date up to 6 months post-palbociclib initiation (for a maximum period of 3 years)
Percentage of Participants According to the Severe Grade of Neutropenia
Neutropenia is an abnormally low level of neutrophils with count <1500 neutrophils per mcL in blood and was classified as per CTC version 2.0 criteria: grade 1 (mild) with an ANC of >=1500 to <2000 cells per mcL, grade 2 (moderate) with an ANC of >=1000 to <1500 cells per mcL, grade 3 (severe) with an ANC of >=500 to <1000 cells per mcL or grade 4 (severe) with an ANC lower than 500 cells per mcL. Percentage of participants with grade 3 and 4 were reported in this outcome measure.
Measured: Data collected from index date up to 3 months post-palbociclib initiation (for a maximum period of 3 years)
Percentage of Participants With Febrile Neutropenia Post-Palbociclib Initiation
Febrile neutropenia (FN) was defined as an ANC of < 1.0 x 10^9 cells/L predicted to fall below 0.5 x 10^9 cells/L within 48 hours with fever or clinical signs of sepsis; fever and ANC were measured the same day or within ± 1 calendar day.
Measured: Data collected from index date up to 3 months post-palbociclib initiation (for a maximum period of 3 years)
Percentage of Participants With Gastro-Intestinal Toxicities Post-Palbociclib Initiation
Percentage of participants with gastro-intestinal toxicities as diarrhea, nausea and vomiting after index date were reported in this outcome measure. As per CTC version 2.0 criteria, for diarrhea: grade 1 (mild)- less than 4 stools per day, grade 2 (moderate)- 4 to 6 stools per day, grade 3 (severe)- >=7 stools per day and grade 4 (life-threatening)- physiologic consequences requiring intensive care; Vomiting: grade 1 (mild)- 1 episode per day , grade 2 (moderate)- 2 to 5 episodes per day, grade 3 (severe)- >=6 episodes per day and grade 4 (life-threatening)- physiologic consequences requiring intensive care; Nausea: grade 1 (mild)- able to eat, grade 2 (moderate)- oral intake significantly reduced, grade 3 (severe)- no significant intake and requiring intravenous fluids.
Measured: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Percentage of Participants With Adverse Events During Follow-up
Percentage of participants with at least one of the adverse events (neutropenia, diarrhea, nausea, and vomiting) after index date were reported in this outcome measure.
Measured: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Absolute Values for Hematology Parameter in First 6 Months Following Palbociclib Initiation: Hemoglobin
Absolute values for hematology parameter- hemoglobin, were reported in this outcome measure.
Measured: From index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)
Absolute Values for Hematology Parameters in First 6 Months Following Palbociclib Initiation: White Blood Cell, Absolute Neutrophil Counts and Platelet Counts
Absolute values for hematology parameters- white blood cell (WBC) counts, absolute neutrophil counts (ANC) and platelet counts (PLT), were reported in this outcome measure.
Measured: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)
Absolute Values for Liver Function Parameters in First 6 Months Following Palbociclib Initiation: Aspartate Aminotransferase, Alanine Aminotransferase and Alkaline Phosphatase
Absolute values for liver function parameters- Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) and Alkaline Phosphatase (ALP), were reported in this outcome measure.
Measured: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)
Absolute Values for Liver Function Parameter in First 6 Months Following Palbociclib Initiation: Albumin
Absolute values for liver function parameter- albumin, were reported in this outcome measure.
Measured: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)
Absolute Values for Liver Function Parameter in First 6 Months Following Palbociclib Initiation: Bilirubin
Absolute values for liver function parameter- bilirubin, were reported in this outcome measure.
Measured: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)
Absolute Values for Bone Profile Parameters in First 6 Months Following Palbociclib Initiation: Calcium and Phosphate
Absolute values for bone profile parameters- calcium and phosphate were reported in this outcome measure.
Measured: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)
Absolute Values for Clinical Chemistry Parameters in First 6 Months Following Palbociclib Initiation: Potassium, Sodium and Urea
Absolute values for clinical chemistry parameters- potassium, sodium and urea were reported in this outcome measure.
Measured: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)
Absolute Values for Clinical Chemistry Parameter in First 6 Months Following Palbociclib Initiation: Creatinine
Absolute values for clinical chemistry parameter- creatinine, were reported in this outcome measure.
Measured: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)
Percentage of Participants With Inpatient Admissions and Outpatient Visits
Percentage of participants with inpatient admissions and outpatient visits were reported in this outcome measure.
Measured: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Number of Inpatient Admissions Per Participant
Measured: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Number of Outpatient Visits Per Participant
Measured: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Percentage of Participants With Type of Hospital Admission
Measured: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Percentage of Participants With Reasons for Hospital Admission
Measured: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Duration of Inpatient Hospital Stay
Duration of hospital stay was the time from the date of hospital entry to date of hospital discharge.
Measured: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Reasons of Outpatient Visit
Measured: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Type of Health Care Professional Consultations During Outpatient Visit
Measured: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Percentage of Participants Contacted Cancer National Service (CNS) and Acute Oncology Service (AOS) During First Year After Palbociclib Initiation
Percentage of participants who contacted CNS by phone calls and AOS either by phone calls or visits were reported in this outcome measure.
Measured: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Percentage of Participants According to Number of CNS Interactions
Measured: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Number of AOS Interactions Per Participant
Measured: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Type of CNS and AOS Interactions
Measured: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Reasons for CNS and AOS Interaction
Measured: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2019
- Study start1 Mar 2019
- Primary completion4 Mar 2021
- Study completion4 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HR+/HER2- Locally Advanced, Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03921866
- Sponsor's protocol ID
- X9001194
- Other IDs
- ROIS
- Acronym
- ROIS
- Status last verified
- Jun 2022
- First submitted
- 17 Apr 2019
- Last updated
- 17 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Publications
Palmieri C, Musson A, Harper-Wynne C, Wheatley D, Bertelli G, Macpherson IR, Nathan M, McDowall E, Bhojwani A, Verrill M, Eva J, Doody C, Chowdhury R. A real-world study of the first use of palbociclib for the treatment of advanced breast cancer within the UK National Health Service as part of the novel Ibrance(R) Patient Program. Br J Cancer. 2023 Sep;129(5):852-860. doi: 10.1038/s41416-023-02352-5. Epub 2023 Jul 19.
PubMed 37468569
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Cohort Study of Patients With Hormone Receptor-positive Metastatic Breast Cancer Treated With Palbociclib (Ibrance(Registered)) as Part of the United Kingdom Ibrance (Registered) Patient Program (IPP); the Real Outcomes Ibrance (Registered) Study (ROIS)
- ClinicalTrials.gov ID
- NCT03921866
- Acronym / sponsor ID
- ROIS / X9001194
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 191 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 4 Mar 2021 (actual)
- Study completion
- 4 Mar 2021 (actual)
- First posted
- 19 Apr 2019 (actual)
- Results
- Posted 17 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
What are the real-world treatment patterns, patients' characteristics, clinical outcomes and healthcare resource utilisation associated with palbociclib treatment in the 3 years following initiation in United Kingdom patients with hormone receptor-positive, human epidermal growth factor 2-negative metastatic breast cancer treated as part of the IPP?
Detailed description
Hormone receptor positive (HR+) breast cancer (BC) represents the largest therapeutic subtype of the disease, accounting for 60 to 65% of all malignant neoplasms of the breast. Palbociclib (Ibrance®) is a small-molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6) which in clinical trial settings has been shown to increase progression-free survival (PFS) for patients with HR+, human epidermal growth factor 2-negative (HER2-) metastatic breast cancer (MBC). Palbociclib first received a European Union (EU) marketing authorisation in September 2016, to be commercialised as Ibrance® by Pfizer. Palbociclib was recommended for use with an aromatase inhibitor in patients with HR+/HER2- locally advanced and MBC in the National Health Service (NHS) in England by the National Institute for Health and Care Excellence (NICE) in November 2017 and by the Scottish Medicines Consortium (SMC) in December 2017. In order to provide access to palbociclib in the United Kingdom (UK) during the NICE/SMC appraisal period, the Ibrance® Patient Program (IPP) was initiated and run by Pfizer between April 2017 until a positive NICE/SMC appraisal in November 2017 (for England and Wales) or December 2017 (for Scotland).
Pfizer are interested in the opportunity to collect data from patients who received palbociclib as part of the UK IPP, to better understand patients' characteristics in a routine care setting, treatment persistence and dose management, clinical outcomes, and healthcare resource utilisation. This study will provide real-world evidence on patients' clinical progression and experience of treatment with palbociclib in routine clinical settings in a UK context.
Research question:
What are the real-world treatment patterns, patients' characteristics, clinical outcomes and healthcare resource utilisation associated with palbociclib treatment in the 3 years following initiation in United Kingdom patients with HR+/HER2- MBC treated as part of the IPP?
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women over the age of 18 who entered into the UK IPP
Key inclusion criteria (5 listed)
- Patients enrolled into the IPP at one of the selected hospitals (see Annex 1 for IPP enrolment letter).
- Patients who received ≥1 dose of palbociclib as part of the IPP at one of the selected sites.
- For sites where data collection is performed by pH Associates, written informed consent will be required from living patients to access their medical records.
- Patient aged ≥18 years old at enrollment into the IPP
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalbociclibPalbociclib | Drug | – |
Primary outcome
Percentage of Participants According to Treatment Lines
Time frame: At baseline
Percentage of participants according to treatment lines during anytime between breast cancer (BC) diagnosis and index date were reported in this outcome measure. Treatment lines included: 1) 1st line where, palbociclib was prescribed as the first line treatment for MBC, 2) 1st line palbociclib added to letrozole where, palbociclib was prescribed as the first line treatment along with ongoing letrozole treatment which was prescribed more than 3 months prior to initiation of palbociclib, 3) 2nd line where palbociclib was prescribed as the second or later treatment line for MBC.
Time From Letrozole to Palbociclib Initiation
Time frame: At baseline
Time from letrozole was defined as duration from the start date of letrozole which was ongoing at the time of palbociclib treatment initiation up to the index date.
Number of Participants With Menopausal Status
Time frame: At baseline
Number of participants with menopausal status as pre-menopausal, peri-menopausal, post-menopausal and not applicable (NA), during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Percentage of Participants According to Disease Free Interval at Palbociclib Initiation
Time frame: At baseline
Disease free interval was defined as the time from the date of last known neo-adjuvant hormone therapy to the date of MBC diagnosis.
Percentage of Participants With Primary or Recurrent Metastatic Breast Cancer Diagnosis
Time frame: At baseline
Percentage of participants with de novo and recurrent metastatic disease, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.
Percentage of Participants With Lymph Nodes Involvement
Time frame: At baseline
Percentage of participants with lymph nodes involvement during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Data for this outcome measure is also presented by de novo status.
Number of Lymph Nodes Involved
Time frame: At baseline
Number of lymph nodes involved during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Data for this outcome measure is also presented by de novo status.
Number of Participants With Estrogen, Progesterone and Human Epidermal Growth Factor 2 (HER2) Receptor Status
Time frame: At baseline
Number of participants with estrogen, progesterone and HER2 receptor status during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Percentage of Participants Who Had Rebiopsy After Metastatic Disease Diagnosis
Time frame: At baseline
Percentage of participants who had rebiopsy during anytime between MBC disease diagnosis and index date were reported in this outcome measure.
Percentage of Participants According to Tumor Stage
Time frame: At baseline
Percentage of participants with tumor stages 0, 1, 2, 3 and 4, as per Tumor, Node, Metastasis (TNM) staging system, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. As per TNM staging system, tumor stage 0 indicates main tumor cannot be found; tumor stages 1, 2, 3 and 4 refers to the size and/or extent of the main tumor. The higher the number, the larger the tumor and/or the more it has spread into nearby tissues. Data for this outcome measure is also presented by de novo status.
Percentage of Participants According to Nodal Status
Time frame: At baseline
Percentage of participants with nodal stages 0, 1, 2 and 3, as per TNM staging system, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. As per TNM staging system, nodal stage 0 indicates no cancer in regional lymph nodes; nodal stages 1= cancer has spread to 1 to 3 lymph nodes; nodal stage 2= cancer has spread to 4 to 9 lymph nodes, nodal stage 3= indicates the cancer has spread to 10 or more lymph nodes. Data for this outcome measure is also presented by de novo status.
Percentage of Participants According to Metastasis
Time frame: At baseline
Percentage of participants with metastasis stages 0 and 1, as per TNM staging system, during anytime between MBC disease diagnosis and index date were reported in this outcome measure. As per TNM staging system, metastasis stage 0 indicates cancer has not spread to other parts of the body; metastasis stage 1 indicates that the cancer has spread to distant parts of the body. Data for this outcome measure is also presented by de novo status.
Tumor Size at Palbociclib Initiation
Time frame: At baseline
Percentage of Participants According to Tumor Grade
Time frame: At baseline
Percentage of participants with tumor grades, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Grades of disease was classified as grades 1, 2 and 3. As per TNM system, grade 1= well differentiated cells, low grade; grade 2= moderately differentiated cells, intermediate grade and grade 3= poorly differentiated cells, high grade.
Percentage of Participants With Ki-67 Protein Proliferation Index Recorded
Time frame: At baseline
Percentage of participants with Ki-67 protein proliferation index during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. The Ki-67 protein is a cellular marker for proliferation. Ki-67 is a protein in cells that increases as cells prepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. More positive cells hasten in dividing and forming new cells. Proliferation index was measured by the percentage of cells staining for Ki-67.
Ki-67 Protein Proliferation Index
Time frame: At baseline
The Ki-67 protein is a cellular marker for proliferation. Ki-67 is a protein in cells that increases as cells prepare to divide into new cells. A staining process can measure the percentage of tumor cells that are positive for Ki-67. More positive cells hasten in dividing and forming new cells. Proliferation index was measured by the percentage of cells staining for Ki-67.
Percentage of Participants With Eastern Cooperative Oncology Group Performance Score (ECOG PS)
Time frame: At baseline
ECOG PS measured quality of life of cancer participants on a 0 to 5 scale; 0= fully active, able to carry on all pre-disease performance without restriction; 1= restricted in physically strenuous activity, ambulatory, able to carry out light/sedentary work; 2= ambulatory, capable of all self-care, unable to carry out any work activity, up >50 % of waking hours; 3= capable of only limited self-care, confined to bed/ chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed or chair; 5= dead. Higher scores indicated worsening of quality of life.
Percentage of Participants With Recurrence Type
Time frame: At baseline
Percentage of participants with recurrence type during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Percentage of Participants According to Number of Metastatic Sites
Time frame: At baseline
Percentage of participants according to number of metastatic sites during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Percentage of Participants According to Location of Metastases
Time frame: At baseline
Percentage of participants according to location of metastases, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Percentage of Participants With Non-Visceral Location of Metastases
Time frame: At baseline
Percentage of participants with non-visceral location of metastases, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Number of Participants According to Metastatic Sites With Locoregional Recurrence
Time frame: At baseline
Number of participants according to metastatic sites with locoregional recurrence, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Metastatic sites with locoregional recurrence included bone, breast, lung, pleural, regional lymph nodes and other sites.
Duration of Disease at Initiation of Palbociclib
Time frame: At baseline
Duration of BC disease was the time duration between date of BC disease diagnosis to palbociclib treatment initiation date.
Percentage of Participants Who Received Chemotherapy in Adjuvant or Neoadjuvant Setting
Time frame: At baseline
Percentage of participants who received chemotherapy in adjuvant or neoadjuvant setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Percentage of Participants Who Received Chemotherapy in Advanced, Disease Modifying or Metastatic Setting
Time frame: At baseline
Percentage of participants who received chemotherapy in advanced, disease modifying or metastatic setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Number of Lines of Prior Chemotherapy for Metastatic Disease
Time frame: At baseline
Number of lines of prior chemotherapy for metastatic disease during anytime between MBC disease diagnosis and index date were reported in this outcome measure.
Percentage of Participants Who Received Luteinizing Hormone Releasing Hormone (LHRH) or Chemotherapy
Time frame: At baseline
Percentage of participants who received LHRH or chemotherapy, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Percentage of Participants Who Received Endocrine Therapy in Adjuvant or Neoadjuvant Setting
Time frame: At baseline
Percentage of participants who received endocrine therapy in adjuvant or neoadjuvant setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Number of Participants With Types of Endocrine Therapy in Adjuvant or Neoadjuvant Setting
Time frame: At baseline
Number of participants with types of endocrine therapy in adjuvant or neoadjuvant setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Percentage of Participants Who Received Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting
Time frame: At baseline
Percentage of participants who received endocrine therapy in advanced, disease modifying or metastatic setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Percentage of Participants With Type of Endocrine Therapy in Advanced, Disease Modifying or Metastatic Setting
Time frame: At baseline
Percentage of participants with type of endocrine therapy in advanced, disease modifying or metastatic setting, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Number of Lines of Prior Endocrine Therapy for Metastatic Disease
Time frame: At baseline
Number of lines of prior endocrine therapy for metastatic disease during anytime between MBC disease diagnosis and index date were reported in this outcome measure.
Number of Participants Who Received Radiotherapy in Advanced, Disease Modifying or Metastatic Setting
Time frame: At baseline
Number of participants who received radiotherapy in advanced, disease modifying or metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.
Percentage of Participants Who Received Concomitant Medications
Time frame: At baseline
Percentage of participants who received concomitant medications, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure.
Number of Participants With Concomitant Medications Prescribed Along With Goserelin
Time frame: At baseline
Number of participants with concomitant medications prescribed along with goserelin, during anytime between initial BC disease diagnosis and index date were reported in this outcome measure. Goserelin is the generic drug with a brand name Zoladex.
Number of Participants According to Number of Prior Treatments in Metastatic Setting
Time frame: At baseline
Number of participants according to number of prior treatments in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.
Number of Participants According to Number of Prior Chemotherapy and Hormone Therapy in Metastatic Setting
Time frame: At baseline
Number of participants according to number of prior chemotherapy and hormone therapy in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.
Number of Participants According to Number of Prior Chemotherapies in Metastatic Setting
Time frame: At baseline
Number of participants according to number of prior chemotherapies in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.
Number of Participants According to Number of Prior Hormone Therapies in Metastatic Setting
Time frame: At baseline
Number of participants according to number of prior hormone therapies in metastatic setting, during anytime between MBC disease diagnosis and index date were reported in this outcome measure.
51 secondary outcomes
Percentage of Participants With Their Starting Dose of Palbociclib
Time frame: Data collected at index date (for a maximum period of 3 years)
Percentage of Participants Who Received Endocrine Therapy Along With Palbociclib
Time frame: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Percentage of Participants With Dose Reductions and Treatment Discontinuation
Time frame: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Number of Participants With Reasons for Palbociclib Discontinuation
Time frame: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Percentage of Participants With Temporary Discontinuation
Time frame: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Percentage of Participants According to Time to Dose Reduction in First Line Therapy
Time frame: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Time to Palbociclib Discontinuation
Time frame: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Number of Participants With First 3 Lines of Treatment After Progression
Time frame: Data collected from date of progression until lost to follow up or end of follow up period, whichever occurred first (for a maximum period of 3 years)
Doses Prescribed for First 3 Lines of Treatment After Progression
Time frame: Data collected from date of progression until lost to follow up or end of follow up period, whichever occurred first (for a maximum period of 3 years)
Duration of First 3 Lines of Treatment After Progression
Time frame: Data collected from date of progression until lost to follow up or end of follow up period, whichever occurred first (for a maximum period of 3 years)
Number of Completed Cycles of Palbociclib
Time frame: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Percentage of Participants Who Received Letrozole and Fulvestrant With Palbociclib
Time frame: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Percentage of Participants With Progression Free Survival Following Palbociclib Initiation
Time frame: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Percentage of Participants Alive Following Palbociclib Initiation
Time frame: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Percentage of Participants With Partial Response (PR) and Complete Response (CR) Following Palbociclib Initiation
Time frame: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Percentage of Participants With Stable Disease (SD) Following Palbociclib Initiation
Time frame: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Progression Free Survival (PFS)
Time frame: From index date to PD or death whichever occurred first (for a maximum period of 3 years)
Overall Survival (OS)
Time frame: From index date until date of death or date of censoring (for a maximum period of 3 years)
Time to Achieving Best Overall Response (BOR)
Time frame: From index date till date of BOR or date of censoring (for a maximum period of 3 years)
Duration of Follow-up Period
Time frame: Data collected from index date until lost to follow up or end of follow up, whichever occurred first (for a maximum period of 3 years)
Percentage of Participants With Best Response (BR), Progressive Disease (PD) and Stable Disease (SD) to Palbociclib
Time frame: From index date till BR (CR or PR, whichever occurred first), SD, PD or date of censoring (for a maximum period of 3 years)
Time to Best Response (BR)
Time frame: From index date till BR or date of censoring (for a maximum period of 3 years)
Time to First Response
Time frame: From index date till first documented CR or PR or date of censoring (for a maximum period of 3 years)
Percentage of Participants With Neutropenia Post-Palbociclib Initiation
Time frame: Data collected from index date up to 6 months post-palbociclib initiation (for a maximum period of 3 years)
Percentage of Participants With Neutropenia Post-Palbociclib Initiation as Recorded and Inferred From Clinical Notes
Time frame: Data collected from index date up to 6 months post-palbociclib initiation (for a maximum period of 3 years)
Percentage of Participants With Neutropenia Post-Palbociclib Initiation as Recorded and Inferred From ANC Measurements
Time frame: Data collected from index date up to 6 months post-palbociclib initiation (for a maximum period of 3 years)
Percentage of Participants According to the Severe Grade of Neutropenia
Time frame: Data collected from index date up to 3 months post-palbociclib initiation (for a maximum period of 3 years)
Percentage of Participants With Febrile Neutropenia Post-Palbociclib Initiation
Time frame: Data collected from index date up to 3 months post-palbociclib initiation (for a maximum period of 3 years)
Percentage of Participants With Gastro-Intestinal Toxicities Post-Palbociclib Initiation
Time frame: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Percentage of Participants With Adverse Events During Follow-up
Time frame: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Absolute Values for Hematology Parameter in First 6 Months Following Palbociclib Initiation: Hemoglobin
Time frame: From index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)
Absolute Values for Hematology Parameters in First 6 Months Following Palbociclib Initiation: White Blood Cell, Absolute Neutrophil Counts and Platelet Counts
Time frame: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)
Absolute Values for Liver Function Parameters in First 6 Months Following Palbociclib Initiation: Aspartate Aminotransferase, Alanine Aminotransferase and Alkaline Phosphatase
Time frame: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)
Absolute Values for Liver Function Parameter in First 6 Months Following Palbociclib Initiation: Albumin
Time frame: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)
Absolute Values for Liver Function Parameter in First 6 Months Following Palbociclib Initiation: Bilirubin
Time frame: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)
Absolute Values for Bone Profile Parameters in First 6 Months Following Palbociclib Initiation: Calcium and Phosphate
Time frame: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)
Absolute Values for Clinical Chemistry Parameters in First 6 Months Following Palbociclib Initiation: Potassium, Sodium and Urea
Time frame: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)
Absolute Values for Clinical Chemistry Parameter in First 6 Months Following Palbociclib Initiation: Creatinine
Time frame: Data collected from index date up to 6 months after palbociclib initiation (for a maximum period of 3 years)
Percentage of Participants With Inpatient Admissions and Outpatient Visits
Time frame: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Number of Inpatient Admissions Per Participant
Time frame: Data collected from index date up to 1-year of follow up period (for a maximum period of 3 years)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37468569Palmieri C, Musson A, Harper-Wynne C, Wheatley D, Bertelli G, Macpherson IR, Nathan M, McDowall E, Bhojwani A, Verrill M, Eva J, Doody C, Chowdhury R. A real-world study of the first use of palbociclib for the treatment of advanced breast cancer within the UK National Health Service as part of the novel Ibrance(R) Patient Program. Br J Cancer. 2023 Sep;129(5):852-860. doi: 10.1038/s41416-023-02352-5. Epub 2023 Jul 19.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HR+/HER2- Locally Advanced, Metastatic Breast Cancer, run by Pfizer at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Mar 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants According to Treatment Lines (time frame: At baseline). The study lists 39 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03921866, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2023.