NCT03708432

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2018

Completed
Last Updated

February 26, 2024

Status Verified

February 1, 2024

Enrollment Period

11 months

First QC Date

October 13, 2018

Last Update Submit

February 23, 2024

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • PFS

    Progression free survival

    6 weeks

Secondary Outcomes (1)

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

    6 weeks

Study Arms (1)

Fulvestrant

Fulvestrant 500mg per month (D1, D28, q28d), with a loading dose 500mg of first dose at D15

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with breast cancer (according to ICD-10) with confirmed metastasis, regardless of being de novo diagnosed or progressed from a non-metastatic stage

You may qualify if:

  • Diagnosed with ER/PR+，HER2- advanced breast cancer
  • Advanced breast cancer included unresectable locally advanced breast cancer, de novo stage IV breast cancer, and recurrent metastatic breast cancer.
  • mg Fulvestrant treatment of advanced breast cancer for at least one month, between Jan 2011 and Dec 2015.
  • Available medical history

You may not qualify if:

  • Incomplete medical history
  • HER2 overexpression or gene amplification, ie, immunohistochemistry (IHC) 3+ or fluorescence in situ hybridisation (FISH)+, where appropriate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • Zhao Y, Li Y, Gong C, Xie Y, Zhang J, Wang L, Cao J, Tao Z, Wang B, Hu X. Optimal duration of prior endocrine therapy predicts the efficacy of Fulvestrant in a real-world study for patients with hormone receptor-positive and HER2-negative advanced breast cancer. Cancer Med. 2020 Dec;9(23):8821-8831. doi: 10.1002/cam4.3491. Epub 2020 Oct 6.

    PMID: 33022852DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Biyun Wang, Professor

    Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 13, 2018

First Posted

October 17, 2018

Study Start

July 15, 2017

Primary Completion

June 15, 2018

Study Completion

August 15, 2018

Last Updated

February 26, 2024

Record last verified: 2024-02

Locations

CN(1)