500mg Fulvestrant Versus Everolimus Plus Exemestane in MBC Patients Refractory to Previous AI

June 16, 2019 updated by: Biyun Wang, MD, Fudan University

Fulvestrant Versus Everolimus Plus Exemestane for Patients With Metastatic Breast Cancer Resistant to Aromatase Inhibitors: the Clinical Experience From Real -World

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

Study Overview

Status

Completed

Conditions

Detailed Description

Fulvestrant versus Everolimus plus Exemestane for patients with Metastatic Breast Cancer resistant to Aromatase Inhibitors: the clinical experience from real -world

Study Type

Observational

Enrollment (Actual)

130

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Fudan University Shanghai Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-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

Description

Inclusion Criteria:

  1. Patients diagnosed with ER/PR+，HER2- Metastatic Breast Cancer
  2. Patients who were refractory to previous Aromatase Inhibitors
  3. 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
  4. Available medical history

Exclusion Criteria:

1.Incomplete medical history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PFS
Time Frame: 6 weeks
Progression free survival
6 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2018

Primary Completion (Actual)

March 10, 2019

Study Completion (Actual)

May 15, 2019

Study Registration Dates

First Submitted

October 2, 2018

First Submitted That Met QC Criteria

October 2, 2018

First Posted (Actual)

October 4, 2018

Study Record Updates

Last Update Posted (Actual)

June 18, 2019

Last Update Submitted That Met QC Criteria

June 16, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YOUNGBC-3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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