Breast CancerNCT04460898
RW Treatment Patterns and Outcomes in Postmenopausal HR+/HER2- mBC Patients Treated With Palbociclib Plus Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
An observational study of Breast Cancer, run by Pfizer at 1 site in United States.
Trial summary
This is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received Palbociclib plus Letrozole as initial endocrine-based therapy in US community oncology network settings. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 195 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2019to 24 Jun 2019
- 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: The study will include adult patients aged 18 years and older, diagnosed with HR+/HER2- mBC and received treatment with Palbociclib in combination with letrozole as initial endocrine-therapy for advanced/metastatic breast cancer.
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Diagnosed with locoregional recurrent or metastatic female breast cancer.
- Pathologically confirmed HR-positive/HER2-negative diagnosis.
- Received treatment with palbociclib in combination with letrozole as initial endocrine-based therapy for advanced/metastatic breast cancer:
- Initiated treatment with palbociclib at least 3 months following the provider's first use of palbociclib following its FDA approval.
- At least 1 month of follow-up (at least one visit with the provider) after initiation of palbociclib.
- Postmenopausal (or receiving surgical or medical treatment to induce menopause) at the time of initiation of palbociclib.
- ≥18 year old at initiation of palbociclib.
Who cannot join
- No exclusion criteria will be imposed for the selection of patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-World Treatment Patterns and Outcomes in Postmenopausal, Hormone-Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative, Metastatic Breast Cancer Patients Treated With Palbociclib Plus an Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
This is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received Palbociclib plus Letrozole as initial endocrine-based therapy in US community oncology network settings.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Patients | HR+/HER2- metastatic breast cancer patients in the US. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants According to Year of Initial Diagnosis of Breast Cancer
Number of participants according to their year of initial diagnosis of breast cancer were reported.
Measured: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Number of Participants With American Joint Committee on Cancer (AJCC) Stage Status
AJCC stages included: stage l (T1N0M0), stage IIA (T0N1M0, T1N1M0, T2N0M0), stage IIB (T2N1M0, T3N0M0), stage IIIA (T0N2M0, T1N2M0, T2N3M0, T3N1 or N2M0), stage IIIB (T4 any NM0, any TN3M0), stage IIIC (any TN3M0), stage IV (any T any NM1), and unknown. T0 = early form of tumor, T1 = less than (<) 2 centimeter (cm), T2 =2-5 cm, T3 = greater than (>) 2 cm, T4 = large sized, N0 = not spread to lymph node (LN), N1 = spread to LN 1 to 3, N2= spread to LN 4 to 9, N3 = spread >10 axillary LN, M0 = no metastasis, M1= metastasis.
Measured: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Number of Participants With Node Status
In this outcome measure, number of participants with node status ranging from N0 to Nx were recorded and reported. N0= No regional lymph node involvement (no cancer found in the lymph nodes), N1-N3= involvement of regional lymph nodes (number and/or extent of spread), and Nx = regional lymph nodes cannot be evaluated. N2 included N2A, and N2B stages; N3 included N3A, N3B, and N3C stages.
Measured: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Number of Participants With Menopausal Status
In this outcome measure, number of participants with menopausal status were recorded and reported. Menopausal status included pre-menopausal, peri-menopausal and post-menopausal.
Measured: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Number of Participants With Type of Metastatic Disease
In this outcome measure, number of participants with de novo metastatic and recurrent types of metastatic disease were recorded and reported.
Measured: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Number of Participants With Sites of Metastatic Disease
Sites of metastatic disease included: locoregional site, adrenal gland, bone, brain, distant lymph nodes, gastrointestinal system, liver, lung, pleura, pericardial, and/or peritoneal cavity. A participant could have more than 1 metastatic site.
Measured: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Number of Participants With Total Number of Metastatic Sites
In this outcome measure, number of participants with total number of metastatic sites ranging from 1 to >3 were recorded and reported.
Measured: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at the Time of Initiation of First-line Treatment
In this outcome measure, number of participants with ECOG at the time of initiation of first-line treatment were included. ECOG scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about >50 percent (%) 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/chair.
Measured: Pre-dose on Day 1 of treatment during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
In this outcome measure, number of participants with various comorbidities at the time of initiation of first-line treatment were recorded and reported. Comorbidities included acquired immune deficiency syndrome/human immune virus (AIDS/HIV), cardiovascular disease, cerebrovascular disease, chronic pulmonary disease, congestive heart failure, connective tissue disease, dementia, depression, diabetes with chronic complications, diabetes without chronic complications, hemiplegia or paraplegia, hypertension, liver disease - mild, moderate, or severe, myocardial infarction, other hematologic malignancy, other non-hematologic malignancy, peptic ulcer disease, peripheral vascular disease, renal disease, thromboembolic events (arterial or venous), and other. One participant could have more than 1 comorbidity. Data with "0" values has not been reported in this outcome measure.
Measured: Pre-dose on Day 1 of treatment during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Charlson Comorbidity Index (CCI) Score
CCI based on various comorbid conditions including myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, rheumatologic disease, peptic ulcer disease, hemiplegia or paraplegia, renal disease, AIDS/HIV, diabetes with and without chronic complications, liver disease (mild, moderate, or severe) was reported. CCI score range was from 0 to 14, where 0= low comorbid condition and 14= high comorbid condition, higher scores indicated more comorbidity.
Measured: Day 1 of treatment during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Number of Participants Who Received Chemotherapy (Neo/Adjuvant) and Hormonal Therapy
In this outcome measure, number of participants who received neo/adjuvant chemotherapy and hormonal (endocrine) therapy were recorded and reported. Neo/Adjuvant chemotherapy and hormonal therapy were the treatments administered before primary cancer treatment to enhance the outcome of primary treatment. Participants reported in rows below are not mutually exclusive.
Measured: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Duration of Adjuvant Therapy
Measured: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Time From Discontinuation of Adjuvant Therapy to Initiation of First-line Treatment
In this outcome measure, time from discontinuation (in months) of adjuvant therapy up to the initiation of first-line treatment of palbociclib combination was recorded and reported.
Measured: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Number of Participants With Different Initial Palbociclib Dose
In this outcome measure, number of participants with different initial dose treatment patterns (125 milligram [mg]/day, 100 mg/day, and 75 mg/day) at palbociclib initiation were recorded and reported.
Measured: Day 1 of treatment during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Total Number of Treatment Cycles Received
Total number of cycles of treatment was the mean number of cycles received by participants prior to the discontinuation of initial treatment of metastatic breast cancer.
Measured: From first-line treatment up to the discontinuation of initial treatment of metastatic breast cancer during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Number of Participants With Dose Reductions
In this outcome measure, number of participants whose dose was reduced from 125 mg/day to 100 mg/day or from 125 mg/day to 75 mg/day, or from 100 mg/day to 75 mg/day were recorded and reported.
Measured: From start to end of treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Number of Participants With Increased Dose Patterns
In this outcome measure, number of participants with increased dose patterns from 100 mg/day to 125 mg/day, 75 mg/day to 125 mg/day, and from 75 mg/day to 100 mg/day were recorded and reported.
Measured: From start to end of treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Number of Participants With Any Treatment Interruptions
In this outcome measure, number of participants whose treatment was interrupted due to any reason (toxicity, no response, loss of response, disease progression (PD), prepare for alternative treatment strategy, participant choice or other) were recorded and reported.
Measured: From start to end of treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Frequency of CBC Testing During First Cycle of Treatment
In this outcome measure, mean of number of complete blood count (CBC) testing was recorded during first cycle of first line (1L) treatment. 1 cycle was of 28 days.
Measured: During first cycle of first line treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Frequency of Electrolyte Testing During First Cycle of First Line Treatment
In this outcome measure, mean of number of electrolyte testing was recorded during first cycle of first line treatment. 1 cycle was of 28 days.
Measured: During first cycle of first line treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Frequency of Liver Function Testing During First Cycle of First Line Treatment
In this outcome measure, mean of liver function testing was recorded during first cycle of first line treatment. 1 cycle was of 28 days.
Measured: During first cycle of first line treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Percentage of Participants With Progression Free Survival (PFS) at Month 6
PFS= time from 1L Palbociclib combination treatment initiation until clinician documented PD while on Palbociclib/death. Participants who discontinued 1L treatment due to toxicity, participant's choice/other reason were censored on date of discontinuation. PD=increase in visible disease \&/or presence of any new lesion; included cases where clinician indicated PD. Percentage of participants who were progression-free \& alive at 6 months following palbociclib initiation was calculated by Kaplan-Meier method. Event (PD/death) = any record of measurable increase in disease (size of lesion at initiation of palbociclib versus most recent scan), presence of new lesions (new sites based on most recent scan/biopsy), notation in participants electronic health record by treating physician that participant had progressed/recorded date of death. Participants were censored if they discontinued 1L treatment with palbociclib due to any reason other than PD/death (toxicity/participant request, etc).
Measured: Month 6 during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Percentage of Participants With Progression Free Survival (PFS) at Month 12
PFS= time from 1L Palbociclib combination treatment initiation until clinician documented PD while on Palbociclib/death. Participants who discontinued 1L treatment due to toxicity, participant's choice/other reason were censored on date of discontinuation. PD=increase in visible disease \&/or presence of any new lesion; included cases where clinician indicated PD. Percentage of participants who were progression-free \& alive at 6 months following palbociclib initiation was calculated by Kaplan-Meier method. Event (PD/death) = any record of measurable increase in disease (size of lesion at initiation of palbociclib versus most recent scan), presence of new lesions (new sites based on most recent scan/biopsy), notation in participants electronic health record by treating physician that participant had progressed/recorded date of death. Participants were censored if they discontinued 1L treatment with palbociclib due to any reason other than PD/death (toxicity/participant request, etc).
Measured: Month 12 during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Percentage of Participants With Progression Free Survival (PFS) at Month 18
PFS= time from 1L Palbociclib combination treatment initiation until clinician documented PD while on Palbociclib/death. Participants who discontinued 1L treatment due to toxicity, participant's choice/other reason were censored on date of discontinuation. PD=increase in visible disease \&/or presence of any new lesion; included cases where clinician indicated PD. Percentage of participants who were progression-free \& alive at 6 months following palbociclib initiation was calculated by Kaplan-Meier method. Event (PD/death) = any record of measurable increase in disease (size of lesion at initiation of palbociclib versus most recent scan), presence of new lesions (new sites based on most recent scan/biopsy), notation in participants electronic health record by treating physician that participant had progressed/recorded date of death. Participants were censored if they discontinued 1L treatment with palbociclib due to any reason other than PD/death (toxicity/participant request, etc).
Measured: Month 18 during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Percentage of Participants With Progression Free Survival (PFS) at Month 24
PFS= time from 1L Palbociclib combination treatment initiation until clinician documented PD while on Palbociclib/death. Participants who discontinued 1L treatment due to toxicity, participant's choice/other reason were censored on date of discontinuation. PD=increase in visible disease \&/or presence of any new lesion; included cases where clinician indicated PD. Percentage of participants who were progression-free \& alive at 6 months following palbociclib initiation was calculated by Kaplan-Meier method. Event (PD/death) = any record of measurable increase in disease (size of lesion at initiation of palbociclib versus most recent scan), presence of new lesions (new sites based on most recent scan/biopsy), notation in participants electronic health record by treating physician that participant had progressed/recorded date of death. Participants were censored if they discontinued 1L treatment with palbociclib due to any reason other than PD/death (toxicity/participant request, etc).
Measured: Month 24 during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Overall Survival (OS)
OS was defined as the interval from the initiation of first line palbociclib combination treatment until death. Participants who were alive at the time of data collection were censored on the last date of visit with their provider.
Measured: From initiation of treatment up to death during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Percentage of Participants With Clinical Benefit Rate (CBR)
CBR was defined as the percentage of participants who achieved complete (where 'complete response' was recorded at any time on treatment) or partial response (where 'partial response' was recorded at any time on treatment), or stable disease at greater than equal to (>=) 24 weeks on palbociclib combination therapy. Stable disease was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Complete response: Complete resolution of all visible disease. Partial response: Partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease
Measured: From initiation of treatment up to CR and PR and SD during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Objective Response Rate (ORR)
ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) on palbociclib combination therapy recorded from first dose of study treatment until disease progression due to any cause. Complete response: complete resolution of all visible disease. Partial response: partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Measured: From initiation of treatment up to CR and PR and SD during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Number of Participants With Stable Disease Lasting Greater Than (>) 24 Weeks
Stable disease was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Complete response: Complete resolution of all visible disease. Partial response: Partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Measured: From initiation of treatment up to end of treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Number of Participants Who Received Drug Regimen Post Discontinuation of Initial Endocrine-Based Therapy
In this outcome measure, number of participants who received drug regimen after discontinuation of initial endocrine-based therapy were recorded and reported.
Measured: Post discontinuation of initial endocrine-based therapy during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Duration of Discontinued Therapy
Discontinuation referred to a treatment persistence terminal event other than regimen change or switch, disease progression, or death. Participants who had a termination of palbociclib for reasons other than regimen change or switch, disease progression, or death were recorded and reported as discontinued.
Measured: Up to 24 months after palbociclib treatment initiation during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start4 Jan 2019
- Primary completion24 Jun 2019
- Study completion24 Jun 2019
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.
- Other trials for 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
- 195 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
- NCT04460898
- Sponsor's protocol ID
- A5481123
- Status last verified
- Jun 2024
- First submitted
- 6 Jul 2020
- Last updated
- 4 Oct 2024
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Treatment Patterns and Outcomes in Postmenopausal, Hormone-Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative, Metastatic Breast Cancer Patients Treated With Palbociclib Plus an Letrozole as Initial Endocrine Therapy at Community Oncology Practices in the U.S.
- ClinicalTrials.gov ID
- NCT04460898
- Acronym / sponsor ID
- A5481123
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 4 Jan 2019 (actual)
- Primary completion
- 24 Jun 2019 (actual)
- Study completion
- 24 Jun 2019 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Posted 4 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a retrospective, observational study that will document treatment patterns and clinical outcomes of postmenopausal patients diagnosed with HR+/HER2- mBC who received Palbociclib plus Letrozole as initial endocrine-based therapy in US community oncology network settings.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Patients | – | –HR+/HER2- metastatic breast cancer patients in the US. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adult patients aged 18 years and older, diagnosed with HR+/HER2- mBC and received treatment with Palbociclib in combination with letrozole as initial endocrine-therapy for advanced/metastatic breast cancer.
Key inclusion criteria (8 listed)
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
Key exclusion criteria (1 listed)
- No exclusion criteria will be imposed for the selection of patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants According to Year of Initial Diagnosis of Breast Cancer
Time frame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Number of participants according to their year of initial diagnosis of breast cancer were reported.
Number of Participants With American Joint Committee on Cancer (AJCC) Stage Status
Time frame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
AJCC stages included: stage l (T1N0M0), stage IIA (T0N1M0, T1N1M0, T2N0M0), stage IIB (T2N1M0, T3N0M0), stage IIIA (T0N2M0, T1N2M0, T2N3M0, T3N1 or N2M0), stage IIIB (T4 any NM0, any TN3M0), stage IIIC (any TN3M0), stage IV (any T any NM1), and unknown. T0 = early form of tumor, T1 = less than (<) 2 centimeter (cm), T2 =2-5 cm, T3 = greater than (>) 2 cm, T4 = large sized, N0 = not spread to lymph node (LN), N1 = spread to LN 1 to 3, N2= spread to LN 4 to 9, N3 = spread >10 axillary LN, M0 = no metastasis, M1= metastasis.
Number of Participants With Node Status
Time frame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
In this outcome measure, number of participants with node status ranging from N0 to Nx were recorded and reported. N0= No regional lymph node involvement (no cancer found in the lymph nodes), N1-N3= involvement of regional lymph nodes (number and/or extent of spread), and Nx = regional lymph nodes cannot be evaluated. N2 included N2A, and N2B stages; N3 included N3A, N3B, and N3C stages.
Number of Participants With Menopausal Status
Time frame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
In this outcome measure, number of participants with menopausal status were recorded and reported. Menopausal status included pre-menopausal, peri-menopausal and post-menopausal.
Number of Participants With Type of Metastatic Disease
Time frame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
In this outcome measure, number of participants with de novo metastatic and recurrent types of metastatic disease were recorded and reported.
Number of Participants With Sites of Metastatic Disease
Time frame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Sites of metastatic disease included: locoregional site, adrenal gland, bone, brain, distant lymph nodes, gastrointestinal system, liver, lung, pleura, pericardial, and/or peritoneal cavity. A participant could have more than 1 metastatic site.
Number of Participants With Total Number of Metastatic Sites
Time frame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
In this outcome measure, number of participants with total number of metastatic sites ranging from 1 to >3 were recorded and reported.
Number of Participants With Eastern Cooperative Oncology Group Performance Status (ECOG-PS) at the Time of Initiation of First-line Treatment
Time frame: Pre-dose on Day 1 of treatment during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
In this outcome measure, number of participants with ECOG at the time of initiation of first-line treatment were included. ECOG scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about >50 percent (%) 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/chair.
Number of Participants With Comorbidities at the Time of Initiation of First-line Treatment
Time frame: Pre-dose on Day 1 of treatment during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
In this outcome measure, number of participants with various comorbidities at the time of initiation of first-line treatment were recorded and reported. Comorbidities included acquired immune deficiency syndrome/human immune virus (AIDS/HIV), cardiovascular disease, cerebrovascular disease, chronic pulmonary disease, congestive heart failure, connective tissue disease, dementia, depression, diabetes with chronic complications, diabetes without chronic complications, hemiplegia or paraplegia, hypertension, liver disease - mild, moderate, or severe, myocardial infarction, other hematologic malignancy, other non-hematologic malignancy, peptic ulcer disease, peripheral vascular disease, renal disease, thromboembolic events (arterial or venous), and other. One participant could have more than 1 comorbidity. Data with "0" values has not been reported in this outcome measure.
Charlson Comorbidity Index (CCI) Score
Time frame: Day 1 of treatment during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
CCI based on various comorbid conditions including myocardial infarction, congestive heart failure, peripheral vascular disease, cerebrovascular disease, dementia, chronic pulmonary disease, rheumatologic disease, peptic ulcer disease, hemiplegia or paraplegia, renal disease, AIDS/HIV, diabetes with and without chronic complications, liver disease (mild, moderate, or severe) was reported. CCI score range was from 0 to 14, where 0= low comorbid condition and 14= high comorbid condition, higher scores indicated more comorbidity.
Number of Participants Who Received Chemotherapy (Neo/Adjuvant) and Hormonal Therapy
Time frame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
In this outcome measure, number of participants who received neo/adjuvant chemotherapy and hormonal (endocrine) therapy were recorded and reported. Neo/Adjuvant chemotherapy and hormonal therapy were the treatments administered before primary cancer treatment to enhance the outcome of primary treatment. Participants reported in rows below are not mutually exclusive.
Duration of Adjuvant Therapy
Time frame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Time From Discontinuation of Adjuvant Therapy to Initiation of First-line Treatment
Time frame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
In this outcome measure, time from discontinuation (in months) of adjuvant therapy up to the initiation of first-line treatment of palbociclib combination was recorded and reported.
Number of Participants With Different Initial Palbociclib Dose
Time frame: Day 1 of treatment during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
In this outcome measure, number of participants with different initial dose treatment patterns (125 milligram [mg]/day, 100 mg/day, and 75 mg/day) at palbociclib initiation were recorded and reported.
Total Number of Treatment Cycles Received
Time frame: From first-line treatment up to the discontinuation of initial treatment of metastatic breast cancer during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Total number of cycles of treatment was the mean number of cycles received by participants prior to the discontinuation of initial treatment of metastatic breast cancer.
Number of Participants With Dose Reductions
Time frame: From start to end of treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
In this outcome measure, number of participants whose dose was reduced from 125 mg/day to 100 mg/day or from 125 mg/day to 75 mg/day, or from 100 mg/day to 75 mg/day were recorded and reported.
Number of Participants With Increased Dose Patterns
Time frame: From start to end of treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
In this outcome measure, number of participants with increased dose patterns from 100 mg/day to 125 mg/day, 75 mg/day to 125 mg/day, and from 75 mg/day to 100 mg/day were recorded and reported.
Number of Participants With Any Treatment Interruptions
Time frame: From start to end of treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
In this outcome measure, number of participants whose treatment was interrupted due to any reason (toxicity, no response, loss of response, disease progression (PD), prepare for alternative treatment strategy, participant choice or other) were recorded and reported.
Frequency of CBC Testing During First Cycle of Treatment
Time frame: During first cycle of first line treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
In this outcome measure, mean of number of complete blood count (CBC) testing was recorded during first cycle of first line (1L) treatment. 1 cycle was of 28 days.
Frequency of Electrolyte Testing During First Cycle of First Line Treatment
Time frame: During first cycle of first line treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
In this outcome measure, mean of number of electrolyte testing was recorded during first cycle of first line treatment. 1 cycle was of 28 days.
Frequency of Liver Function Testing During First Cycle of First Line Treatment
Time frame: During first cycle of first line treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
In this outcome measure, mean of liver function testing was recorded during first cycle of first line treatment. 1 cycle was of 28 days.
Percentage of Participants With Progression Free Survival (PFS) at Month 6
Time frame: Month 6 during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
PFS= time from 1L Palbociclib combination treatment initiation until clinician documented PD while on Palbociclib/death. Participants who discontinued 1L treatment due to toxicity, participant's choice/other reason were censored on date of discontinuation. PD=increase in visible disease \&/or presence of any new lesion; included cases where clinician indicated PD. Percentage of participants who were progression-free \& alive at 6 months following palbociclib initiation was calculated by Kaplan-Meier method. Event (PD/death) = any record of measurable increase in disease (size of lesion at initiation of palbociclib versus most recent scan), presence of new lesions (new sites based on most recent scan/biopsy), notation in participants electronic health record by treating physician that participant had progressed/recorded date of death. Participants were censored if they discontinued 1L treatment with palbociclib due to any reason other than PD/death (toxicity/participant request, etc).
Percentage of Participants With Progression Free Survival (PFS) at Month 12
Time frame: Month 12 during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
PFS= time from 1L Palbociclib combination treatment initiation until clinician documented PD while on Palbociclib/death. Participants who discontinued 1L treatment due to toxicity, participant's choice/other reason were censored on date of discontinuation. PD=increase in visible disease \&/or presence of any new lesion; included cases where clinician indicated PD. Percentage of participants who were progression-free \& alive at 6 months following palbociclib initiation was calculated by Kaplan-Meier method. Event (PD/death) = any record of measurable increase in disease (size of lesion at initiation of palbociclib versus most recent scan), presence of new lesions (new sites based on most recent scan/biopsy), notation in participants electronic health record by treating physician that participant had progressed/recorded date of death. Participants were censored if they discontinued 1L treatment with palbociclib due to any reason other than PD/death (toxicity/participant request, etc).
Percentage of Participants With Progression Free Survival (PFS) at Month 18
Time frame: Month 18 during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
PFS= time from 1L Palbociclib combination treatment initiation until clinician documented PD while on Palbociclib/death. Participants who discontinued 1L treatment due to toxicity, participant's choice/other reason were censored on date of discontinuation. PD=increase in visible disease \&/or presence of any new lesion; included cases where clinician indicated PD. Percentage of participants who were progression-free \& alive at 6 months following palbociclib initiation was calculated by Kaplan-Meier method. Event (PD/death) = any record of measurable increase in disease (size of lesion at initiation of palbociclib versus most recent scan), presence of new lesions (new sites based on most recent scan/biopsy), notation in participants electronic health record by treating physician that participant had progressed/recorded date of death. Participants were censored if they discontinued 1L treatment with palbociclib due to any reason other than PD/death (toxicity/participant request, etc).
Percentage of Participants With Progression Free Survival (PFS) at Month 24
Time frame: Month 24 during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
PFS= time from 1L Palbociclib combination treatment initiation until clinician documented PD while on Palbociclib/death. Participants who discontinued 1L treatment due to toxicity, participant's choice/other reason were censored on date of discontinuation. PD=increase in visible disease \&/or presence of any new lesion; included cases where clinician indicated PD. Percentage of participants who were progression-free \& alive at 6 months following palbociclib initiation was calculated by Kaplan-Meier method. Event (PD/death) = any record of measurable increase in disease (size of lesion at initiation of palbociclib versus most recent scan), presence of new lesions (new sites based on most recent scan/biopsy), notation in participants electronic health record by treating physician that participant had progressed/recorded date of death. Participants were censored if they discontinued 1L treatment with palbociclib due to any reason other than PD/death (toxicity/participant request, etc).
Overall Survival (OS)
Time frame: From initiation of treatment up to death during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
OS was defined as the interval from the initiation of first line palbociclib combination treatment until death. Participants who were alive at the time of data collection were censored on the last date of visit with their provider.
Percentage of Participants With Clinical Benefit Rate (CBR)
Time frame: From initiation of treatment up to CR and PR and SD during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
CBR was defined as the percentage of participants who achieved complete (where 'complete response' was recorded at any time on treatment) or partial response (where 'partial response' was recorded at any time on treatment), or stable disease at greater than equal to (>=) 24 weeks on palbociclib combination therapy. Stable disease was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Complete response: Complete resolution of all visible disease. Partial response: Partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease
Objective Response Rate (ORR)
Time frame: From initiation of treatment up to CR and PR and SD during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
ORR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) on palbociclib combination therapy recorded from first dose of study treatment until disease progression due to any cause. Complete response: complete resolution of all visible disease. Partial response: partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Number of Participants With Stable Disease Lasting Greater Than (>) 24 Weeks
Time frame: From initiation of treatment up to end of treatment during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Stable disease was defined as no evidence of complete or partial response, and no progression on palbociclib therapy for 24 weeks or greater. Complete response: Complete resolution of all visible disease. Partial response: Partial reduction in size of visible disease in some or all areas without any areas of increase in visible disease.
Number of Participants Who Received Drug Regimen Post Discontinuation of Initial Endocrine-Based Therapy
Time frame: Post discontinuation of initial endocrine-based therapy during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
In this outcome measure, number of participants who received drug regimen after discontinuation of initial endocrine-based therapy were recorded and reported.
Duration of Discontinued Therapy
Time frame: Up to 24 months after palbociclib treatment initiation during data identification of approximatively 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)
Discontinuation referred to a treatment persistence terminal event other than regimen change or switch, disease progression, or death. Participants who had a termination of palbociclib for reasons other than regimen change or switch, disease progression, or death were recorded and reported as discontinued.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Pfizer at 1 site in United States.
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 8 inclusion and 1 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 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 4 Oct 2024). 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?
Number of Participants According to Year of Initial Diagnosis of Breast Cancer (time frame: Baseline during data identification period of approximately 4 years (from the data retrieved and observed retrospectively over a duration of 5.7 months)). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Oct 2024.