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Treatment After Progression of Fulvestrant Among Metastatic Breast Cancer Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03541863
Enrollment
131
Registered
2018-05-31
Start date
2017-10-10
Completion date
2018-12-20
Last updated
2019-02-15

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

Conditions

Breast Cancer

Keywords

Fulvestrant, Progression, Endocrine sensitivity

Brief summary

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

Detailed 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.

Interventions

None listed

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
PFS6 weeksProgression free survival

Secondary

MeasureTime frameDescription
OSFrom 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 monthsOverall survival
Number of participants with treatment-related adverse events as assessed by CTCAE v4.06 weeks

Other

MeasureTime frameDescription
Fulvestrant sensitivity6 weeksTime cutoff of Fulvestrant PFS related to next line ET or CT efficacy

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026