500mg Fulvestrant in HR+ MBC

NCT ID: NCT03708432

Last Updated: 2024-02-26

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

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-07-15

Study Completion Date

2018-08-15

Brief Summary

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To study the real world use of 500mg Fulvestrant in HR+ MBC.

Detailed Description

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An observational, retrospective study of 500mg Fulvestrant in hormone receptor+/HER2- advanced breast cancer

Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Fulvestrant

Fulvestrant 500mg per month (D1, D28, q28d), with a loading dose 500mg of first dose at D15

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Diagnosed with ER/PR+,HER2- advanced breast cancer
2. Advanced breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.

3.500mg Fulvestrant treatment of advanced breast cancer for at least one month, between Jan 2011 and Dec 2015.

4.Available medical history

Exclusion Criteria

1. Incomplete medical history
2. HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Biyun Wang, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Biyun Wang, Professor

Role: PRINCIPAL_INVESTIGATOR

Fudan University

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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Zhao Y, Li Y, Gong C, Xie Y, Zhang J, Wang L, Cao J, Tao Z, Wang B, Hu X. Optimal duration of prior endocrine therapy predicts the efficacy of Fulvestrant in a real-world study for patients with hormone receptor-positive and HER2-negative advanced breast cancer. Cancer Med. 2020 Dec;9(23):8821-8831. doi: 10.1002/cam4.3491. Epub 2020 Oct 6.

Reference Type DERIVED
PMID: 33022852 (View on PubMed)

Other Identifiers

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YOUNGBC-4

Identifier Type: -

Identifier Source: org_study_id

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