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Completed

NCT Number: NCT03541863

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Disease Attributes Disease Progression Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. PFS

    Time frame: 6 weeks

    Progression free survival

Secondary outcomes

  1. OS

    Time frame: 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

    Overall survival

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Time frame: 6 weeks

Other outcomes

  1. Fulvestrant sensitivity

    Time frame: 6 weeks

    Time cutoff of Fulvestrant PFS related to next line ET or CT efficacy

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 31, 2018
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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