A Study to Describe the Breast Cancer Patient Population, Treatment, and Results in Indian Patients Receiving Combinations of the Medicines Called Palbociclib for Advanced Breast Cancer

An observational study of Breast Cancer and Breast Carcinoma, run by Pfizer at 6 sites in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this clinical study is to describe the patient population, breast cancer treatment, and breast cancer treatment results of adult female patients who have received palbociclib combination treatments for advanced or metastatic breast cancer in India. Read more about this study

Who is it for?: Ages 18 to 99 years, women only
Conditions the study is for: Breast Cancer, Breast Carcinoma, Breast Neoplasms
What is being tested?: Palbociclib plus hormonal treatment - first line treatment and Palbociclib plus hormonal treatment - second line treatment
How many people: 150 participants
Where: 6 sitesIndia
Study dates: 24 May 2021to 22 Feb 2022
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 to 99 years
Women only
No healthy volunteers
Adult, Older adult

Study population: Adult menopausal women with confirmed metastatic or advanced breast cancer in India

Who may be able to join

HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease
Received palbociclib with aromatase inhibitor (as prescribed by the Physician) as initial endocrine therapy in postmenopausal metastatic breast cancer (MBC) patients or with fulvestrant in patients who have progressed on prior endocrine therapy
Patients on Leutinizing Hormone Releasing Hormone (LHRH) agonists for ovarian function suppression in pre- or perimenopausal stage only if prescribed palbociclib with fulvestrant
No prior or current enrolment in an interventional clinical trial for advanced/metastatic breast cancer
Minimum of 3 months of follow up data since palbociclib with fulvestrant initiation, or minimum of 6 months of follow up data since palbociclib with aromatase inhibitor initiation

Who cannot join

Cancers other than breast cancer
Male breast cancer
Visceral crisis

Trial locations and contacts

6 sites in 1 country.

City, postcode or hospital

6 sites in 1 country

India6 sites

HCG Cancer Centre
Ahmedabad, Gujarat, India, 380060
Bhagwan Mahaveer Cancer Hospital and Research Centre
Bajājnagar, Jaipur, Rajasthan, India, 302018
Indo-American Hospital
Nandi Nagar, Banjara Hills, Hyderabad, Telangana, India, 500034
Max Super Speciality Hospital
Patparganj, Delhi, India, 110092
Hemato Oncology Clinic Ahmedabad Private Limited
Rajpath Club Lane ,Gujarat, India, Ahmedabad, 380054
Max Super Speciality Hospital
Saket Institutional Area,, Saket, NEW Delhi, India, 110017

Other trials in India

About this study

Official title: Treatment Patterns and Clinical Outcomes Among Indian Patients Receiving Palbociclib Combinations for HR+/HER2- Advanced/Metastatic Breast Cancer in Real World Settings

There are two groups of patients this study will describe. The first group of patients will have received palbociclib in combination with aromatase inhibitor (as prescribed by the Physician) for the treatment of postmenopausal women with HR+/HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease. The second group of patients will have received palbociclib for the treatment of hormone receptor HR+/HER2- advanced or metastatic breast cancer in combination with fulvestrant in women with disease progression following endocrine therapy.

Conditions: Breast Cancer, Breast Carcinoma, Breast Neoplasms, Breast Tumors, Cancer of Breast
Being tested: Palbociclib plus hormonal treatment - first line treatment, Palbociclib plus hormonal treatment - second line treatment
Keywords: Hormone receptor positive / human epidermal growth factor 2 negative (HR+/HER2-), Advanced Breast Cancer, Metastatic Breast Cancer, Palbociclib, aromatase inhibitor, fulvestrant
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Palbociclib plus hormonal treatment - first line treatmentDrug
Palbociclib plus hormonal treatment
Palbociclib plus hormonal treatment - second line treatmentDrug
Palbociclib plus hormonal treatment

Study groups in NCT05584644
Study group	Role	What they receive
Palbociclib plus hormonal treatment - first line treatment		Patients who initiated Palbociclib + hormonal therapy in the first line treatment Receives: Drug: Palbociclib plus hormonal treatment - first line treatment
Palbociclib plus hormonal treatment - second line treatment		Patients who initiated palbociclib plus hormonal treatment in the second line treatment Receives: Drug: Palbociclib plus hormonal treatment - second line treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants According to the Starting Dose of Palbociclib
Number of participants according to their starting dose (125 milligrams per day [mg/day], 100 mg/day) of palbociclib were reported in this outcome measure. For participants whose dose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Duration of Treatment
Duration of treatment was reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date to end of treatment, from Dec 2016 to May 2021 (approximately 4.5 years); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of Participants Who Had Any Palbociclib Dose Reduction
Number of participants according to dose reductions during palbociclib treatment were reported in this outcome measure. Dose was reduced to 100mg and 75 mg. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of Participants Who Had Any Interruption in Palbociclib Treatment
Number of participants with any interruptions during palbociclib treatment were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of Participants Who Had Any Delays in Palbociclib Treatment
Number of participants who had any delay in palbociclib treatment were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of Participants According to Reasons for Treatment Discontinuation
Number of participants classified according to reasons for treatment discontinuations which included increased transaminases, cardiomyopathy was reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of Participants According to Reasons for Change in Treatment
Number of participants classified according to reasons for change in treatment were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Progression Free Survival
Progression free survival was defined as the time from palbociclib combination treatment initiation until 1) clinician documented disease progression (PD) while on palbociclib, 2) death, 3) start of a new therapy line after final palbociclib dose, if the reason for discontinuation of palbociclib was disease progression, or 4) last available follow-up, whichever occurred first. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date to death or disease progression start of new therapy or last available follow-up whichever occurred first,maximum up to approximately 4.5years;available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Objective Response Rate (ORR)
The objective response rate was defined as the percentage of participants with complete response (CR) and partial response (PR). As per RECIST version 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date to CR/PR, from Dec 2016 to May 2021 (approximately 4.5 years); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of Participants Who Died
Number of participants who died were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date to death, from Dec 2016 to May 2021 (approximately 4.5 years); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Overall Survival (OS)
OS was defined as the time from index date to the date of death due to any cause. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date to death due to any cause, (from Dec 2016 to May 2021 [approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of Participants According to Biomarker Status
Number of participants classified according to the biomarker status were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of Participants With Family History of Breast Cancer
Number of participants with family history of breast cancer were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Duration From Breast Cancer Diagnosis to Palbociclib Treatment
Duration from breast cancer diagnosis to palbociclib treatment was reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of Participants According to Stages of Breast Cancer
Number of participants classified according to stages (Stage I, II, IIIa, IV) of breast cancer were included in this outcome measure. Stage I indicated the cancer was small and had not spread anywhere else, Stage II indicated the cancer had grown, but had not spread, Stage IIIa indicated the cancer had grown larger and might have spread to the surrounding tissues and/or the lymph nodes. Stage IV indicated the cancer had spread from where it started to at least 1 other body organ, also known as secondary or metastatic cancer. For participants whose breast cancer stage were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of Participants According to Node Status
Number of participants classified according to node status were included in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of Participants According to Menopausal Status
Number of participants classified according to menopausal status which included natural and induced were included in this outcome measure. For participants whose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
ECOG PS was used to assess physical health of participants. ECOG PS grade:0= fully active, able to carry on all pre-disease performance without restriction,1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2= ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours, 3= capable of only limited self-care, 4= completely disabled, cannot carry on any selfcare totally confined to bed or chair confined to bed or chair more than 50% of waking hours and 5= dead. Participants whose ECOG scores were not available reported as 'data not available'. Only those categories with non-zero values were reported. Index date= 60 days after physician first prescribed palbociclib + hormonal following availability of specific indication in market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of Participants According to Metastatic Sites
Number of participants classified according to metastatic sites were reported in this outcome measure. Metastatic sites included bone, lung, liver, lymph nodes, others. For participants whose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. Participant could have more than 1 location of metastases.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of Participants According to de Novo and Recurrent Disease
Participants classified according to status of disease as de novo versus and recurrent disease were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of Participants According to Therapies Received for Early Breast Cancer
Participants classified according to therapies received for early breast cancer which included adjuvant chemotherapy, adjuvant endocrine therapy, neoadjuvant treatment, radiotherapy, surgery were reported in this outcome measure. For participants whose details were not available was reported under 'data not available'. Participant could have received more than 1 therapy. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Time Since End of Adjuvant Treatment
Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis
Participants were classified according to supportive therapies received for HR+/HER2- diagnosis and were reported in this outcome measure. Supportive therapies included nutritional treatment, bisphosphonates, anti-anxiety, anti-depressant, anti-emetics, non-steroidal anti-inflammatory drugs. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Duration of Supportive Treatments for ABC/MBC
Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of Participants According to Reasons for Regimen Change
Participants were classified according to reasons for regimen change and were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Measured: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 May 202122 Feb 2022

First posted18 Oct 2022
Study start24 May 2021
Primary completion22 Feb 2022
Study completion22 Feb 2022

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: Case only
Time perspective: Retrospective
Enrolment: 150 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05584644
Sponsor's protocol ID: A5481145
Status last verified: Dec 2023
First submitted: 23 May 2022
Last updated: 19 Dec 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment Patterns and Clinical Outcomes Among Indian Patients Receiving Palbociclib Combinations for HR+/HER2- Advanced/Metastatic Breast Cancer in Real World Settings
ClinicalTrials.gov ID: NCT05584644
Acronym / sponsor ID: A5481145
Conditions: Breast Cancer, Breast Carcinoma, Breast Neoplasms, Breast Tumors, Cancer of Breast
Keywords: Hormone receptor positive / human epidermal growth factor 2 negative (HR+/HER2-), Advanced Breast Cancer, Metastatic Breast Cancer, Palbociclib, aromatase inhibitor, fulvestrant
Study type: Observational
Recruitment status: Completed
Enrolment: 150 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 24 May 2021 (actual)
Primary completion: 22 Feb 2022 (actual)
Study completion: 22 Feb 2022 (actual)
First posted: 18 Oct 2022 (actual)
Results: Posted 5 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
Palbociclib plus hormonal treatment - first line treatment	–	Drug: Palbociclib plus hormonal treatment - first line treatmentPatients who initiated Palbociclib + hormonal therapy in the first line treatment
Palbociclib plus hormonal treatment - second line treatment	–	Drug: Palbociclib plus hormonal treatment - second line treatmentPatients who initiated palbociclib plus hormonal treatment in the second line treatment

Who may qualify

Ages: 18 to 99 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Adult menopausal women with confirmed metastatic or advanced breast cancer in India

Key inclusion criteria (5 listed)

HR+/HER2- breast cancer diagnosis with confirmed metastatic or advanced disease
Received palbociclib with aromatase inhibitor (as prescribed by the Physician) as initial endocrine therapy in postmenopausal metastatic breast cancer (MBC) patients or with fulvestrant in patients who have progressed on prior endocrine therapy
Patients on Leutinizing Hormone Releasing Hormone (LHRH) agonists for ovarian function suppression in pre- or perimenopausal stage only if prescribed palbociclib with fulvestrant
No prior or current enrolment in an interventional clinical trial for advanced/metastatic breast cancer
Minimum of 3 months of follow up data since palbociclib with fulvestrant initiation, or minimum of 6 months of follow up data since palbociclib with aromatase inhibitor initiation

Key exclusion criteria (3 listed)

Cancers other than breast cancer
Male breast cancer
Visceral crisis

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
Palbociclib plus hormonal treatment - first line treatmentPalbociclib plus hormonal treatment	Drug	Palbociclib plus hormonal treatment - first line treatment
Palbociclib plus hormonal treatment - second line treatmentPalbociclib plus hormonal treatment	Drug	Palbociclib plus hormonal treatment - second line treatment

Primary outcome

Number of Participants According to the Starting Dose of Palbociclib
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of participants according to their starting dose (125 milligrams per day [mg/day], 100 mg/day) of palbociclib were reported in this outcome measure. For participants whose dose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Duration of Treatment
Time frame: From index date to end of treatment, from Dec 2016 to May 2021 (approximately 4.5 years); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Duration of treatment was reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Number of Participants Who Had Any Palbociclib Dose Reduction
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of participants according to dose reductions during palbociclib treatment were reported in this outcome measure. Dose was reduced to 100mg and 75 mg. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Number of Participants Who Had Any Interruption in Palbociclib Treatment
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of participants with any interruptions during palbociclib treatment were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Number of Participants Who Had Any Delays in Palbociclib Treatment
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of participants who had any delay in palbociclib treatment were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Number of Participants According to Reasons for Treatment Discontinuation
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of participants classified according to reasons for treatment discontinuations which included increased transaminases, cardiomyopathy was reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Number of Participants According to Reasons for Change in Treatment
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of participants classified according to reasons for change in treatment were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Progression Free Survival
Time frame: From index date to death or disease progression start of new therapy or last available follow-up whichever occurred first,maximum up to approximately 4.5years;available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Progression free survival was defined as the time from palbociclib combination treatment initiation until 1) clinician documented disease progression (PD) while on palbociclib, 2) death, 3) start of a new therapy line after final palbociclib dose, if the reason for discontinuation of palbociclib was disease progression, or 4) last available follow-up, whichever occurred first. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Objective Response Rate (ORR)
Time frame: From index date to CR/PR, from Dec 2016 to May 2021 (approximately 4.5 years); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
The objective response rate was defined as the percentage of participants with complete response (CR) and partial response (PR). As per RECIST version 1.1 criteria: CR = disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). Disappearance of all non-target lesions and normalization of tumor marker level. All lymph nodes must be non-pathological in size (<10 mm short axis); PR = at least 30% decrease in sum of diameters of target lesions taking as reference baseline sum diameters. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Number of Participants Who Died
Time frame: From index date to death, from Dec 2016 to May 2021 (approximately 4.5 years); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of participants who died were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Overall Survival (OS)
Time frame: From index date to death due to any cause, (from Dec 2016 to May 2021 [approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
OS was defined as the time from index date to the date of death due to any cause. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Number of Participants According to Biomarker Status
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of participants classified according to the biomarker status were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Number of Participants With Family History of Breast Cancer
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of participants with family history of breast cancer were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Duration From Breast Cancer Diagnosis to Palbociclib Treatment
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Duration from breast cancer diagnosis to palbociclib treatment was reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Number of Participants According to Stages of Breast Cancer
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of participants classified according to stages (Stage I, II, IIIa, IV) of breast cancer were included in this outcome measure. Stage I indicated the cancer was small and had not spread anywhere else, Stage II indicated the cancer had grown, but had not spread, Stage IIIa indicated the cancer had grown larger and might have spread to the surrounding tissues and/or the lymph nodes. Stage IV indicated the cancer had spread from where it started to at least 1 other body organ, also known as secondary or metastatic cancer. For participants whose breast cancer stage were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Number of Participants According to Node Status
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of participants classified according to node status were included in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Number of Participants According to Menopausal Status
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of participants classified according to menopausal status which included natural and induced were included in this outcome measure. For participants whose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
ECOG PS was used to assess physical health of participants. ECOG PS grade:0= fully active, able to carry on all pre-disease performance without restriction,1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2= ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours, 3= capable of only limited self-care, 4= completely disabled, cannot carry on any selfcare totally confined to bed or chair confined to bed or chair more than 50% of waking hours and 5= dead. Participants whose ECOG scores were not available reported as 'data not available'. Only those categories with non-zero values were reported. Index date= 60 days after physician first prescribed palbociclib + hormonal following availability of specific indication in market.
Number of Participants According to Metastatic Sites
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Number of participants classified according to metastatic sites were reported in this outcome measure. Metastatic sites included bone, lung, liver, lymph nodes, others. For participants whose details were not available was reported under 'data not available'. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market. Participant could have more than 1 location of metastases.
Number of Participants According to de Novo and Recurrent Disease
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Participants classified according to status of disease as de novo versus and recurrent disease were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Number of Participants According to Therapies Received for Early Breast Cancer
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Participants classified according to therapies received for early breast cancer which included adjuvant chemotherapy, adjuvant endocrine therapy, neoadjuvant treatment, radiotherapy, surgery were reported in this outcome measure. For participants whose details were not available was reported under 'data not available'. Participant could have received more than 1 therapy. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Time Since End of Adjuvant Treatment
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Participants were classified according to supportive therapies received for HR+/HER2- diagnosis and were reported in this outcome measure. Supportive therapies included nutritional treatment, bisphosphonates, anti-anxiety, anti-depressant, anti-emetics, non-steroidal anti-inflammatory drugs. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Duration of Supportive Treatments for ABC/MBC
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.
Number of Participants According to Reasons for Regimen Change
Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)
Participants were classified according to reasons for regimen change and were reported in this outcome measure. Index date was defined as 60 days after the physician first prescribed palbociclib + hormonal therapy (letrozole, fulvestrant or anastrozole for first line and letrozole, fulvestrant or exemestane for second line therapy) following the availability of specific indication in the market.

Results and safety

Results posted to the registry on 5 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Palbociclib: 1st Line Therapy	105	105
Palbociclib: 2nd Line Therapy	45	45

Primary outcome: Number of Participants According to the Starting Dose of Palbociclib

Time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study). Count of participants. Unit: Participants

Measure	Palbociclib: 1st Line Therapy n = 105	Palbociclib: 2nd Line Therapy n = 45
125mg/day	99	43
100mg/day	1	2
Data not available	5	0

Population analysed: Analysis population included all eligible participants whose data were retrieved and observed in this study.

Primary outcome: Duration of Treatment

Time frame: From index date to end of treatment, from Dec 2016 to May 2021 (approximately 4.5 years); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study). Median (Inter-Quartile Range). Unit: Months

Measure	Palbociclib: 1st Line Therapy n = 105	Palbociclib: 2nd Line Therapy n = 45
Value	15.08 (9.67 to 22.43)	11.63 (6.37 to 19.60)

Population analysed: Analysis population included all eligible participants whose data were retrieved and observed in this study.

Primary outcome: Number of Participants Who Had Any Palbociclib Dose Reduction

Measure	Palbociclib: 1st Line Therapy n = 105	Palbociclib: 2nd Line Therapy n = 45
Dose reduced to 100 mg	13	1
Dose reduced to 75 mg	1	0

Population analysed: Analysis population included all eligible participants whose data were retrieved and observed in this study.

Primary outcome: Number of Participants Who Had Any Interruption in Palbociclib Treatment

Measure	Palbociclib: 1st Line Therapy n = 105	Palbociclib: 2nd Line Therapy n = 45
Value	9	1

Population analysed: Analysis population included all eligible participants whose data were retrieved and observed in this study.

Adverse events

Time frame: From index date until end of follow up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Palbociclib: 1st Line Therapy	4 of 105 (3.8%)	2 of 105 (1.9%)	8 of 105
Palbociclib: 2nd Line Therapy	0 of 45 (0%)	0 of 45 (0%)	3 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
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.

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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

6 sites 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 and Breast Carcinoma, run by Pfizer at 6 sites in India.

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 3 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 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in India. 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 5 Dec 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?

Number of Participants According to the Starting Dose of Palbociclib (time frame: From index date until end of follow-up (anytime from Dec 2016 to May 2021[approximately 4.5 years]); available data studied from 24-May-2021 to 22-Feb-2022 (approximately 9 months of this study)). The study lists 25 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 NCT05584644.

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 19 Dec 2023.