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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Bicalutamide

Aromatase Inhibitor

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring androgen receptor, bicalutamide, aromatase inhibitors, advanced breast cancer, letrozole, anastrozole, exemestane

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

State Key Laboratory of Oncology in South China,Sun Yat-sen University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

bicalutamide+ Aromatase Inhibitor

Arm Description

ER(+)/AR(+)/HER2(+) metastatic breast cancer patients that previously treated by an aromatase inhibitor

Outcomes

Primary Outcome Measures

clinical benefit rate（CBR）

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.

Secondary Outcome Measures

progression free survival

Time from to the first documentation of objective tumor progression or to death due to any cause.

objective response rate of bicalutamide plus another AI in participants with measurable disease

objective response rate includes complete response, partial response.

tolerability of bicalutamide plus an Aromatase inhibitor

evaluate and quality of life of the participants using Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) .

Full Information

NCT ID

NCT02910050

First Posted

September 6, 2016

Last Updated

December 21, 2017

Sponsor

Xu fei

Collaborators

Sun Yat-sen University

1. Study Identification

Unique Protocol Identification Number

NCT02910050

Brief Title

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

Acronym

BETTER

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 2016 (undefined)

Primary Completion Date

September 2018 (Anticipated)

Study Completion Date

December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Xu fei

Collaborators

Sun Yat-sen University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

androgen receptor, bicalutamide, aromatase inhibitors, advanced breast cancer, letrozole, anastrozole, exemestane

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

bicalutamide+ Aromatase Inhibitor

Arm Type

Experimental

Arm Description

ER(+)/AR(+)/HER2(+) metastatic breast cancer patients that previously treated by an aromatase inhibitor

Intervention Type

Drug

Intervention Name(s)

Bicalutamide

Other Intervention Name(s)

Casodex

Intervention Description

50mg once a day orally

Intervention Type

Drug

Intervention Name(s)

Aromatase Inhibitor

Other Intervention Name(s)

letrozole, anastrozole, exemestane

Intervention Description

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

Primary Outcome Measure Information:

Title

clinical benefit rate（CBR）

Description

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

progression free survival

Description

Time from to the first documentation of objective tumor progression or to death due to any cause.

Time Frame

baseline up to approximately 6 months

Title

objective response rate of bicalutamide plus another AI in participants with measurable disease

Description

objective response rate includes complete response, partial response.

Time Frame

24 weeks

Title

tolerability of bicalutamide plus an Aromatase inhibitor

Description

evaluate and quality of life of the participants using Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) .

Time Frame

2 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fei Xu, MD

Phone

+86-13711277870

xiawen@sysucc.org.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Fei Xu, MD

Organizational Affiliation

Sun Yat-sen University

Official's Role

Principal Investigator

Facility Information:

Facility Name

State Key Laboratory of Oncology in South China,Sun Yat-sen University Cancer Center

City

Guangzhou

State/Province

Guangdong

ZIP/Postal Code

510060

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Fei Xu, MD

Phone

+86-13711277870

xufei@sysucc.org.cn

12. IPD Sharing Statement

Plan to Share IPD

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

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