500mg Fulvestrant in HR+ MBC

An Observational, Retrospective Study of 500mg Fulvestrant in Hormone Receptor+/HER2- Advanced Breast Cancer

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03708432

Enrollment

100

Registered

2018-10-17

Start date

2017-07-15

Completion date

2018-08-15

Last updated

2024-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
PFS	6 weeks	Progression free survival

Secondary

Measure	Time frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0	6 weeks

Countries

China

Outcome results