Fulvestrant 500mg in Patients With Advanced Breast Cancer

NCT02909361 | Unknown

• 1 other identifier: Fudan BR2016-21
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Fulvestrant 500mg in Patients With Advanced Breast Cancer

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• ORR

  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

  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

  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

  From date of randomization until the date of date of death from any cause or last visit, assessed up to 100 months.

Study Arms (1)

Fulvestrant

500 mg on days 0, 14, and 28, and every 28 days thereafter

Drug: Fulvestrant

Interventions

Fulvestrant DRUG

500 mg on days 0, 14, and 28, and every 28 days thereafter

Also known as: Fulvestrant Injection

Fulvestrant

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, 200032, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Plasma Sample will be collected at the time of study start and discontinuation base on the clinical practice.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Xichun Hu, MD, PhD

  Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 53 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of department of medical oncology

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: September 21, 2016
• Study Start: October 11, 2017
• Primary Completion: June 1, 2022
• Study Completion: October 1, 2022
• Last Updated: April 20, 2022

Record last verified: 2022-04

Locations

CN (1)