Bicalutamide Plus Aromatase Inhibitors in ER(+)/AR(+)/HER2(-) Metastatic Breast Cancer (BETTER)

December 21, 2017 updated by: Xu fei

A Phase II Study of the Efficacy and Tolerability of Bicalutamide Plus Aromatase Inhibitors in Estrogen Receptor(+)/Androgen Receptor(+)/HER2(-) Metastatic Breast Cancer

This study is aim to evaluate the efficacy and safety of bicalutamide and aromatase inhibitor in ER(+)/AR(+)/HER2(-) metastatic breast cancer patients who have disease progression after treatment of an aromatase inhibitor.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Androgen receptor(AR) is closely related to molecular type, treatment and prognosis in breast cancer. Over 70% of breast cancer expressed androgen receptor. And in some estrogen receptor positive breast cancer cells which are resistant to Aromatase inhibitors can change androgen receptor dependent. So AR may be a new target in the treatment of breast cancer. Bicalutamide is a selective androgen receptor inhibitor with a clinical benefit rate of 19% and median progression free survival of 12 weeks in the ER-/AR+ metastatic breast cancer. This study is aim to evaluate the efficacy and safety of bicalutamide and aromatase inhibitor in ER+/AR+/HER- metastatic breast cancer patients who have disease progression after treatment of an AI.

Study Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Phase 2

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • State Key Laboratory of Oncology in South China,Sun Yat-sen University Cancer Center
        • Contact:

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients with histologically confirmed estrogen receptor positive, androgen positive and HER2 negative breast cancer
  • Metastatic or unresectable locally advanced disease
  • Age over 18 years
  • Postmenopausal status （continuous using luteinizing hormone releasing hormone(LHRH) analogue is available）
  • Patient must have disease progression after treatment of an Aromatase inhibitor.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS)0-2
  • Life expectancy over 3 months.
  • Measurable disease according to RECIST version 1.1 or only bone metastasis
  • Adequate hematological, hepatic function.
  • Voluntarily signed and dated written informed consent prior to any study specific procedure.

Exclusion Criteria:

  • Patient with life-threatening visceral metastasis, such as extensive liver metastasis, brain or meningeal metastasis
  • Concomitant diseases/conditions that is not controllable, and Any other major illness that, in the Investigator's judgment, will substantially increase the risk associated with the patient's participation in this study.
  • History of other primary malignancy
  • Resistant to steroidal or nonsteroidal aromatase Inhibitor

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: bicalutamide+ Aromatase Inhibitor
ER(+)/AR(+)/HER2(+) metastatic breast cancer patients that previously treated by an aromatase inhibitor
Drug: Bicalutamide
50mg once a day orally
Other Names:
  • Casodex
Drug: Aromatase Inhibitor
participants will receive any kind of aromatase inhibitor which has not been received before (steroidal AI change to nonsteroidal AI and vice versa), Letrozole 2.5mg once a day orally, Anastrozole 1mg once a day orally, Exemestane 25mg once a day orally
Other Names:
  • exemestane
  • letrozole
  • anastrozole

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
clinical benefit rate（CBR）
Time Frame: 24 weeks
Response and progression will be evaluated using RECIST 1.1. Evaluation will occur every 2 months for the first 6 months and then every 3 months till progression or termination of the study.CBR is defined as ratio of participants who have stable disease for over 24 weeks.
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
progression free survival
Time Frame: baseline up to approximately 6 months
Time from to the first documentation of objective tumor progression or to death due to any cause.
baseline up to approximately 6 months
objective response rate of bicalutamide plus another AI in participants with measurable disease
Time Frame: 24 weeks
objective response rate includes complete response, partial response.
24 weeks
tolerability of bicalutamide plus an Aromatase inhibitor
Time Frame: 2 years
evaluate and quality of life of the participants using Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) .
2 years

Collaborators and Investigators

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

Sponsor

Xu fei

Collaborators

Sun Yat-sen 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

January 1, 2016

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

September 20, 2016

First Posted (Estimate)

September 21, 2016

Study Record Updates

Last Update Posted (Actual)

December 22, 2017

Last Update Submitted That Met QC Criteria

December 21, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SYSU5010-2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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