NCT03695341

Brief Summary

500mg Fulvestrant versus Everolimus plus Exemestane in MBC patients refractory to previous AI

Trial Health

87
On Track

Trial Health Score

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

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2018

Shorter than P25 for all trials

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

May 14, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 2, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 10, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

10 months

First QC Date

October 2, 2018

Last Update Submit

June 16, 2019

Conditions

Breast Cancer

Keywords

Endocrine TherapyFulvestrantEverolimus

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

Everolimus plus Exemestane

Everolimys 10 mg or 5 mg daily; 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:

  • Patients diagnosed with ER/PR+，HER2- Metastatic Breast Cancer
  • Patients who were refractory to previous Aromatase Inhibitors
  • Patients treated with Fulvestrant or Everolimus plus Exemestane in any line in metastatic setting in Fudan University Shanghai Cancer Center，starting from 2013.06.01-2016.06.01
  • Available medical history

You may not qualify if:

  • Incomplete medical history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (1)

  • Li Y, Xie Y, Gong C, Zhao Y, Zhang J, Zhang S, Wang L, Chen S, Hu X, Wang B. Comparative Treatment Patterns and Outcomes of Fulvestrant versus Everolimus Plus Exemestane for Postmenopausal Metastatic Breast Cancer Resistant to Aromatase Inhibitors in Real-World Experience. Ther Clin Risk Manag. 2020 Jun 30;16:607-615. doi: 10.2147/TCRM.S255365. eCollection 2020.

    PMID: 32636632DERIVED

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 2, 2018

First Posted

October 4, 2018

Study Start

May 14, 2018

Primary Completion

March 10, 2019

Study Completion

May 15, 2019

Last Updated

June 18, 2019

Record last verified: 2019-06

Locations

CN(1)