Fulvestrant 500mg in Patients With Advanced Breast Cancer

April 19, 2022 updated by: Xichun Hu, Fudan University

A Multicenter, Prospective, Real-world Study to Evaluate the Safety Profile and Effectiveness in Chinese Patients Who Received Fulvestrant 500mg as First-line Endocrine Treatment for Advanced Breast Cancer

Fulvestrant 500mg in Patients With Advanced Breast Cancer

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A multicenter, prospective study real-world to evaluate the safety profile and effectiveness in Chinese patients who received Fulvestrant 500mg as first-line endocrine treatment for Advanced breast cancer

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200032
        • Fudan University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Chinese women with estrogen receptor positive, locally advanced or metastatic breast cancer.

Description

Inclusion Criteria:

  1. Chinese women with estrogen receptor positive, locally advanced or metastatic breast cancer who has already received Fulvestant 500mg treatment as determined by treating physician. Ovarian suppression in premenopausal women is permitted, including ovarian ablation and LHRHa.
  2. Histologically confirmed positive oestrogen receptor status (ER positive) of primary breast cancer or metastatic tumour tissue, according to the local laboratory parameters.
  3. Prior endocrine therapy for advanced disease was not permitted.
  4. The prescription of the Fulvestant is clearly separated from the decision to include the subject in the NIS, and is part of normal medical practice. The recruitment of the patient to the study should be within 1 month of the first Fulvestant injection.
  5. Provision of subject informed consent.

Exclusion Criteria:

  1. If participating in any controlled clinical trial, the subject cannot take part in this study.
  2. HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.
  3. Pervious regimen of endocrine therapy for advanced disease.
  4. More than one regimen of chemotherapy for advanced disease.
  5. Pregnancy and lactation.
  6. Severe hepatic impairment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fulvestrant
500 mg on days 0, 14, and 28, and every 28 days thereafter
Drug: Fulvestrant
500 mg on days 0, 14, and 28, and every 28 days thereafter
Other Names:
  • Fulvestrant Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence, nature and severity of all Adverse Events assessed by CTCAE V4.0
Time Frame: From date of randomization until the date of date of death from any cause or last visit, assessed up to 100 months.
Incidence, nature and severity of all Adverse Events assessed by CTCAE V4.0
From date of randomization until the date of date of death from any cause or last visit, assessed up to 100 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Objective Response Rate
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
CBR
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Clinical Benefit Rate
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
PFS
Time Frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
Progression Free Survival
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months.
OS
Time Frame: From date of randomization until the date of date of death from any cause or last visit, assessed up to 100 months.
Overall Survival
From date of randomization until the date of date of death from any cause or last visit, assessed up to 100 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 11, 2017

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

October 1, 2022

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 18, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Actual)

April 20, 2022

Last Update Submitted That Met QC Criteria

April 19, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Fudan BR2016-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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