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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Biyun Wang, MD，Fudan University

Tracking Information

First Submitted Date ^ICMJE

October 2, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

May 14, 2018

Estimated Primary Completion Date

March 10, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

PFS[ Time Frame: 6 weeks ]

Progression free survival

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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

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 ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Study Arms

: 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

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

150

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

May 15, 2019

Estimated Primary Completion Date

March 10, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

China

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Biyun Wang, MD，Fudan University

Study Sponsor ^ICMJE

Fudan University

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Biyun Wang, Professor Fudan University

PRS Account

Fudan University

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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