Bicalutamide Plus Aromatase Inhibitors in ER(+)/AR(+)/HER2(-) Metastatic Breast Cancer (BETTER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02910050|
Recruitment Status : Recruiting
First Posted : September 21, 2016
Last Update Posted : December 22, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Bicalutamide Drug: Aromatase Inhibitor||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2016|
|Estimated Primary Completion Date :||September 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: bicalutamide+ Aromatase Inhibitor
ER(+)/AR(+)/HER2(+) metastatic breast cancer patients that previously treated by an aromatase inhibitor
50mg once a day orally
Other Name: 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
- 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.
- 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.
- 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.
- 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) .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910050
|Contact: Fei Xu, MDemail@example.com|
|State Key Laboratory of Oncology in South China,Sun Yat-sen University Cancer Center||Recruiting|
|Guangzhou, Guangdong, China, 510060|
|Contact: Fei Xu, MD +86-13711277870 firstname.lastname@example.org|
|Principal Investigator:||Fei Xu, MD||Sun Yat-sen University|