Clinical trial NCT05584644: 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
Official title: Treatment Patterns and Clinical Outcomes Among Indian Patients Receiving Palbociclib Combinations for HR+/HER2- Advanced/Metastatic Breast Cancer in Real World Settings
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2022-10-18
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult menopausal women with confirmed metastatic or advanced breast cancer in India

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Cancers other than breast cancer
* Male breast cancer
* Visceral crisis

Primary outcomes:
measure: Number of Participants According to the Starting Dose of Palbociclib
timeFrame: 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)
measure: Duration of Treatment
timeFrame: 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)
measure: Number of Participants Who Had Any Palbociclib Dose Reduction
timeFrame: 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)
measure: Number of Participants Who Had Any Interruption in Palbociclib Treatment
timeFrame: 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)
measure: Number of Participants Who Had Any Delays in Palbociclib Treatment
timeFrame: 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)
measure: Number of Participants According to Reasons for Treatment Discontinuation
timeFrame: 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)
measure: Number of Participants According to Reasons for Change in Treatment
timeFrame: 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)
measure: Progression Free Survival
timeFrame: 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)
measure: Objective Response Rate (ORR)
timeFrame: 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)
measure: Number of Participants Who Died
timeFrame: 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)
measure: Overall Survival (OS)
timeFrame: 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)
measure: Number of Participants According to Biomarker Status
timeFrame: 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)
measure: Number of Participants With Family History of Breast Cancer
timeFrame: 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)
measure: Duration From Breast Cancer Diagnosis to Palbociclib Treatment
timeFrame: 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)
measure: Number of Participants According to Stages of Breast Cancer
timeFrame: 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)
measure: Number of Participants According to Node Status
timeFrame: 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)
measure: Number of Participants According to Menopausal Status
timeFrame: 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)
measure: Number of Participants According to Performance Status Based on Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
timeFrame: 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)
measure: Number of Participants According to Metastatic Sites
timeFrame: 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)
measure: Number of Participants According to de Novo and Recurrent Disease
timeFrame: 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)
measure: Number of Participants According to Therapies Received for Early Breast Cancer
timeFrame: 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)
measure: Time Since End of Adjuvant Treatment
timeFrame: 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)
measure: Number of Participants According to Supportive Therapies Received for Hormone Receptor Positive / Human Epidermal Growth Factor 2 Negative (HR+/HER2-) Diagnosis
timeFrame: 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)
measure: Duration of Supportive Treatments for ABC/MBC
timeFrame: 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)
measure: Number of Participants According to Reasons for Regimen Change
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Rajpath Club Lane ,Gujarat, India
country: India
facility: Hemato Oncology Clinic Ahmedabad Private Limited
state: Ahmedabad
city: Patparganj
country: India
facility: Max Super Speciality Hospital
state: Delhi, India
city: Ahmedabad
country: India
facility: HCG Cancer Centre
state: Gujarat, India
city: Nandi Nagar, Banjara Hills
country: India
facility: Indo-American Hospital
state: Hyderabad, Telangana, India
city: Bajaj Nagar
country: India
facility: Bhagwan Mahaveer Cancer Hospital and Research Centre
state: Jaipur, Rajasthan, India
city: Saket Institutional Area,
country: India
facility: Max Super Speciality Hospital
state: Saket, NEW Delhi, India
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: