NCT03575260

Brief Summary

500mg Fulvestrant versus Exemestane in MBC

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

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 1, 2017

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 2, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2019

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

1.5 years

First QC Date

June 21, 2018

Last Update Submit

July 29, 2019

Conditions

Breast Cancer

Keywords

FulvestrantExemestane

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 (2)

Fulvestrant

Fulvestrant 500 mg on days 0, 14, and 28, and every 28 days thereafter

Exemestane

Exemestane 25mg per day

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:

  • Postmenopausal woman, age \> 18 years old
  • Diagnosed with ER/PR+，HER2- Metastatic Breast Cancer
  • Adjuvant treatment of Non-steroidal Aromatase Inhibitors
  • First line of Metastatic Breast Cancer is 500mg Fulvestrant or Exemestane for at least one month, starting from 2014.01.01-2017.06.01
  • Available medical history

You may not qualify if:

  • Incomplete medical history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biyun Wang, MD

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • Xie Y, Li Y, Zhang Y, Zhang S, Li W, Guan X, Zhao Y, Gong C, Hu X, Zhang J, Cao E, Wang L, Ge R, Wang B. Fulvestrant 500 mg Versus Exemestane in Postmenopausal Women With Metastatic Breast Cancer Resistant to Adjuvant Nonsteroidal Aromatase Inhibitors in Clinical Practice: A Multicenter Retrospective Study. Clin Breast Cancer. 2019 Jun;19(3):e452-e458. doi: 10.1016/j.clbc.2019.01.015. Epub 2019 Feb 7.

    PMID: 30846408DERIVED

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

June 21, 2018

First Posted

July 2, 2018

Study Start

July 1, 2017

Primary Completion

January 10, 2019

Study Completion

January 15, 2019

Last Updated

July 30, 2019

Record last verified: 2019-07

Locations

CN(1)