NCT03541863

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 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

October 10, 2017

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 31, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2018

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2018

Completed
Last Updated

February 15, 2019

Status Verified

February 1, 2019

Enrollment Period

1.2 years

First QC Date

May 6, 2018

Last Update Submit

February 13, 2019

Conditions

Breast Cancer

Keywords

FulvestrantProgressionEndocrine sensitivity

Outcome Measures

Primary Outcomes (1)

  • PFS

    Progression free survival

    6 weeks

Secondary Outcomes (2)

  • OS

    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

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

    6 weeks

Other Outcomes (1)

  • Fulvestrant sensitivity

    6 weeks

Study Arms (2)

Endocrine therapy

use endocrine therapy (ET) after Fulvestrant, include but not limited to: tamoxifen, anastrozole, letrozole, exemestane, exemestane + everolimus

Chemotherapy

use Chemotherapy (CT) after Fulvestrant, include but not limited to: capecitabine, docetaxel-based, vinorelbine, paclitaxel-based

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (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:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Breast NeoplasmsDisease Progression

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

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

May 6, 2018

First Posted

May 31, 2018

Study Start

October 10, 2017

Primary Completion

December 15, 2018

Study Completion

December 20, 2018

Last Updated

February 15, 2019

Record last verified: 2019-02

Locations

CN(1)