Neoplasms

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Breast Neoplasms

Breast Diseases

Skin Diseases

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Fulvestrant

Palbociclib

Aromatase Inhibitors

Antineoplastic Agents, Hormonal

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Protein Kinase Inhibitors

Enzyme Inhibitors

Adult patients with HR+/HER2- advanced breast cancer who received the initial endocrine therapy of palbociclib plus aromatase inhibitor at the Cancer Hospital Chinese Academy of Medical Sciences from August 1, 2018 to December 31, 2020.

Adult patients with HR+/HER2- advanced breast cancer who received the initial endocrine therapy of fulvestrant monotherapy at the Cancer Hospital Chinese Academy of Medical Sciences from August 1, 2018 to December 31, 2020.

palbociclib + aromatase inhibitor therapy

palbociclib + aromatase inhibitor

fulvestrant

Peng Yuan, M.D.

A retrospective cohort study conducted at the Cancer Hospital Chinese Academy of Medical Sciences to compare the effectiveness of palbociclib plus AI therapy and fulvestrant monotherapy as initial endocrine therapy in the patients with HR+/HER2- advanced breast cancer.

This study is designed to be a retrospective cohort study conducted at the Cancer Hospital Chinese Academy of Medical Sciences. The target populations of this study are patients with HR+/HER2- advanced breast cancer who received the initial endocrine therapy of palbociclib plus AI or fulvestrant monotherapy from August 1, 2018 to December 31, 2020. It is expected to enroll 600 subjects in this study. The subjects' data such as demographics and other baseline characteristics, medications, prognosis, will be collected retrospectively, and statistical analysis of data will be conducted to compare the effectiveness outcome measures.

Comparative Effectiveness of Palbociclib Plus AI Versus Fulvestrant for HR+/HER2- ABC

Comparative Effectiveness of Palbociclib Plus Aromatase Inhibitor Versus Fulvestrant Alone as Initial Endocrine Therapy for HR+/HER2- Advanced Breast Cancer in Chinese Clinical Practice: a Real-world Study

It is defined as the time (months) from the start of palbociclib+AI or fulvestrant monotherapy to progressive disease or all-cause mortality. The progressive disease is determined by clinicians based on the results of clinical evaluation, laboratory tests, imaging or pathological examinations. Patients who have not died or have not experienced progressive disease will be censored at the beginning of next-line treatment or at the last visit during the study period.

It is defined as the time (months) from the start of palbociclib+AI or fulvestrant monotherapy to all-cause mortality. Patients who have not died are censored on the study deadline.

Real world ORR is defined as the proportion of patients with complete response (CR) or partial response (PR) reported by doctors among all patients with response data available.Real world CBR is defined as the proportion of patients who have reached CR, PR, or stable disease (SD) for at least 24 weeks reported by the doctors among all patients with response data available.

Chinese Academy of Medical Sciences

Professor

Menopause

Palbociclib + aromatase inhibitor

Aromatase inhibitor

Pfizer CT.gov Call Center

This study aims to assess real-world tumor response in pre/perimenopausal HR+/HER2- metastatic breast cancer (MBC) patients initiating palbociclib + aromatase inhibitor (AI) or AI alone as first-line therapy during the period on or after 01 January 2010 to on or before 30 June 2020. Data will be obtained from structured data fields within an electronic health record (EHR) database and will be supplemented by additional unstructured data collected through a targeted chart review.

pre-menopausal metastatic breast cancer patients

Comparative Real World Tumor Response in Pre-menopausal Metastatic Breast Cancer Patients Treated With Palbociclib + Aromatase Inhibitor or Aromatase Inhibitor Alone

REAL-WORLD TUMOR RESPONSE OF PALBOCICLIB IN COMBINATION WITH AN AROMATASE INHIBITOR AS FIRST-LINE THERAPY IN PRE/PERIMENOPAUSAL WOMEN WITH METASTATIC BREAST CANCER

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.

rwRR defined as the proportion of patients with real-world tumor response consisting of complete response (CR) or partial response (PR) based on all recorded response assessments during first-line therapy captured with chart review.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparative Effectiveness of Palbociclib Plus AI Versus Fulvestrant for HR+/HER2- ABC	NCT05000736	Hormone Recepto...	palbociclib + a... fulvestrant	18 Years -	ChineseAMS
Comparative Real World Tumor Response in Pre-menopausal Metastatic Breast Cancer Patients Treated With Palbociclib + Aromatase Inhibitor or Aromatase Inhibitor Alone	NCT05012644	Metastatic Brea...	Palbociclib + a... Aromatase inhib...	-	Pfizer
Comparative Real World Tumor Response in Pre-menopausal Metastatic Breast Cancer Patients Treated With Palbociclib + Aromatase Inhibitor or Aromatase Inhibitor Alone	NCT05012644	Metastatic Brea...	Palbociclib + a... Aromatase inhib...	-	Pfizer
Comparative Effectiveness of Palbociclib Plus AI Versus Fulvestrant for HR+/HER2- ABC	NCT05000736	Hormone Recepto...	palbociclib + a... fulvestrant	18 Years -	ChineseAMS

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