Fulvestrant 500mg in Patients With Advanced Breast Cancer | NCT02909361

Studies
Fulvestrant 500mg in Patients With Advanced Breast Cancer

NCT02909361

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Apr 20, 2022Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Metastatic Breast Cancer

Interventions

Fulvestrant

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 11, 2017Actual

Primary Completion Date

Jun 2022Estimated

Completion Date

Oct 2022Estimated

First Submitted Date

Sep 12, 2016

First Submission Date that Met QC Criteria

Sep 18, 2016

First Posted Date

Sep 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 19, 2022

Last Update Posted Date

Apr 20, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Fulvestrant 500mg in Patients With Advanced Breast Cancer

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

53 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Fulvestrant		500 mg on days 0, 14, and 28, and every 28 days thereafter	Drug: Fulvestrant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fulvestrant	Drug	500 mg on days 0, 14, and 28, and every 28 days thereafter	Fulvestrant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence, nature and severity of all Adverse Events assessed by CTCAE V4.0	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 Outcomes

Measure	Description	Time Frame
ORR	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	Clinical Benefit Rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.
Histologically confirmed positive oestrogen receptor status (ER positive) of primary breast cancer or metastatic tumour tissue, according to the local laboratory parameters.
Prior endocrine therapy for advanced disease was not permitted.
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.
Provision of subject informed consent.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

ID	Term
D004958	Estradiol
D004963	Estrenes
D004962	Estranes
D013256	Steroids
D000072473