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

NCT ID: NCT05000736

Last Updated: 2022-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-09-01

Study Completion Date

2022-09-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hormone Receptor Positive Advanced Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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palbociclib + aromatase inhibitor

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.

palbociclib + aromatase inhibitor

Intervention Type DRUG

palbociclib + aromatase inhibitor therapy

fulvestrant

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.

fulvestrant

Intervention Type DRUG

fulvestrant monotherapy

Interventions

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palbociclib + aromatase inhibitor

palbociclib + aromatase inhibitor therapy

Intervention Type DRUG

fulvestrant

fulvestrant monotherapy

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Chinese women ≥18 years old;
2. Diagnosed with locally advanced (stage IIIb/IIIc) or metastatic (stage IV) breast cancer;
3. The molecular classification is pathologically confirmed as HR+/HER2-;
4. Palbociclib plus AI or fulvestrant monotherapy as initial endocrine therapy for advanced breast cancer for at least 1 cycle;
5. The follow-up time should be not less than 3 months after the start of palbociclib plus AI therapy or fulvestrant monotherapy.

Exclusion Criteria

1\. Subjects who have previously received chemotherapy, other CDK4/6 inhibitors or other endocrine monotherapy for advanced breast cancer.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Chinese Academy of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Peng Yuan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peng Yuan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Locations

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Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Peng Yuan, M.D.

Role: CONTACT

+8613501270834

Facility Contacts

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Peng Yuan, M.D.

Role: primary

+8613501270834

Other Identifiers

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CH-BC-086

Identifier Type: -

Identifier Source: org_study_id

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