Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

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

Adult patients with HR+/HER2- advanced breast cancer who received palbociclib based-therapy as initial endocrine therapy from August 1, 2018 to December 31, 2023.

Adult patients with HR+/HER2- advanced breast cancer who received palbociclib based-therapy after chemotherapy from August 1, 2018 to December 31, 2023.

Palbociclib + aromatase inhibitor/fulvestrant (initial endocrine therapy)

Palbociclib based-therapy as initial endocrine therapy

Palbociclib + aromatase inhibitor/fulvestrant (after chemotherapy)

Palbociclib based-therapy after chemotherapy

A multi-center non-interventional observational study led by the Cancer Hospital Chinese Academy of Medical Sciences to compare the effectiveness of palbociclib based-therapy as initial endocrine therapy versus palbociclib based-therapy after chemotherapy for HR+/HER2- advanced breast cancer.

This study is designed to be a multi-center non-interventional observational study led by the Cancer Hospital Chinese Academy of Medical Sciences. The target populations of this study are patients with HR+/HER2- advanced breast cancer who received palbociclib based-therapy as initial endocrine therapy or palbociclib based-therapy after chemotherapy from August 1, 2018 to December 31, 2023. It is expected to enroll 400 subjects in this study. The subjects' data such as demographics and other baseline characteristics, medications, prognosis, will be collected in a mixed manner, and statistical analysis of data will be conducted to compare the effectiveness outcome measures.

Comparative Effectiveness of PAL Based-therapy as Initial ET Versus PAL Based-therapy After ChT for HR+/HER2- ABC

Comparative Effectiveness of Palbociclib Based-therapy as Initial Endocrine Therapy Versus Palbociclib Based-therapy After Chemotherapy 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 based-therapy 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.

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.

DCR is defined as the proportion of patients who have reached CR, PR, or stable disease (SD) reported by the doctors among all patients with response data available.

Vinorelbine

Tubulin Modulators

Antimitotic Agents

Fluvestrant in combination with oral Vinorelbine Fluvestrant: administered at a dose of 0.5g once im every 28 days. Vinorelbine: administered at a dose of 60mg/kg once a week for 3 weeks p.o. every 28 days.

Eligible patients will be treated with the fluvestrant + oral vinorelbine regimen until the disease progresses or intolerable toxicity

fluvestrant + oral vinorelbine

Xue Wang, M.D.

Peng Yuan

This is a single-center phase II study designed to evaluated the efficacy and safety of fulvestrant in combination with oral vinorelbine in hormone receptor-positive advanced breast cancer

This is a single-group, single-center phase II trial. Patients with hormone-receptor-positive, Her2-negative recurrent or metastatic breast cancer who had not previously received any systemic antitumor therapy for advanced disease were treated with fulvestrant combined with oral vinorelbine as a first-line regimen. Key issues to be addressed in this study: to observe and evaluate the efficacy and safety of fulvestrant combined with oral vinorelbine in the treatment of hormone-receptor-positive and HER2-negative advanced breast cancer. Thirty patients are planned to be enrolled.

A Study of Fluvestrant Combined With Oral Vinorelbine in Hormone Receptor-positive Advanced Breast Cancer

Phase II Study of Fluvestrant Combined With Oral Vinorelbine in Hormone Receptor-positive Advanced Breast Cancer

PFS will be defined as the time from first dose of study drug until documentation of disease progression or death from any cause

The ORR will be calculated as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR)

hematologic toxicity，hepatotoxicity and so on

Principal Investigator

Carcinoma

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Cetuximab

Letrozole

Antineoplastic Agents, Immunological

Pfizer CT.gov Call Center

The purpose of this clinical trial is to provide study medicine(s) and learn about their safety. This study is seeking participants who:

* Have benefited from ongoing study treatment as determined by the study doctor in a Pfizer-sponsored palbociclib Parent Study
* Must agree to follow the reproductive criteria
* Are willing and able to comply with all scheduled visits, treatment plans, and other study procedures
* Can give signed informed consent documents

Participants in this study will continue to receive treatment as they were in the parent study. The time by which participants will take part in this study is retrospective (after completed parent study). We will examine the experiences of people receiving the study medicine(s). This will help us determine if the study medicine(s) are safe. During this time, the participants will be monitored for the safety of the study medicine(s).

This is an open-label study to provide continued access to treatment for eligible participants who continue to derive clinical benefit as determined by the investigator from study intervention(s) in a Pfizer-sponsored palbociclib clinical study (Parent Study)

Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies

A TREATMENT PROTOCOL FOR PARTICIPANTS CONTINUING FROM PFIZER-SPONSORED PALBOCICLIB CLINICAL STUDIES

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.

An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

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 Effectiveness of PAL Based-therapy as Initial ET Versus PAL Based-therapy After ChT for HR+/HER2- ABC	NCT05343117	Hormone Recepto...	Palbociclib bas... Palbociclib bas...	18 Years -	ChineseAMS
Comparative Effectiveness of Palbociclib Plus AI Versus Fulvestrant for HR+/HER2- ABC	NCT05000736	Hormone Recepto...	palbociclib + a... fulvestrant	18 Years -	ChineseAMS
A Study of Fluvestrant Combined With Oral Vinorelbine in Hormone Receptor-positive Advanced Breast Cancer	NCT03939871	Hormone Recepto...	fluvestrant + o...	18 Years - 70 Years	ChineseAMS
Study for Participants Continuing From Pfizer-sponsored Palbociclib (a Study Medicine) Studies	NCT05226871	Breast Cancer Head and Neck C...	Palbociclib Cetuximab Fulvestrant Letrozole	18 Years -	Pfizer

Spots Global Cancer Trial Database for hormone receptor positive advanced breast cancer