Treatment After Progression of Fulvestrant Among Metastatic Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

What Comes After Fulvestrant? A Real World Multicenter Retrospective Study-Treatment After Progression of Fulvestrant Among Metastatic Breast Cancer Patients in China

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03541863
• Other study ID #: YOUNGBC-1
• Status: Completed
• Start date: October 10, 2017
• Est. completion date: December 20, 2018

Study information

• Verified date: February 2019
• Source: Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

What Comes After Fulvestrant? A Real World Multicenter Retrospective Study-Treatment After Progression of Fulvestrant Among Metastatic Breast Cancer Patients in China.

Description:

There is no evidence of treatment after progression of Ful. We retrospectively evaluated HR+, HER2- MBC patients failed on Ful 500mg as first line or second line therapy from 2014 to 2017 in 6 institutions. Treatment pattern, PFS, OS and safety were analyzed to figure out the situation and efficacy of treatment after Fulvestrant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 131
• Est. completion date: December 20, 2018
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients who were treated with Fulvestrant between June 2014 to June 2017 as first line or second line therapy

• Patients received subsequent treatment after progressing on Fulvestrant for at least one cycle (>1 month)

• Complete medical history was available

Exclusion Criteria:

• Subsequent treatment was not standard therapy (cannot be classified into endocrine therapy/ chemotherapy)

• Medical history was incomplete

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Disease Progression

Locations

Country	Name	City	State
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Fulvestrant sensitivity	Time cutoff of Fulvestrant PFS related to next line ET or CT efficacy	6 weeks
Primary	PFS	Progression free survival	6 weeks
Secondary	OS	Overall survival	From date of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		6 weeks