A study to evaluate the efficacy and safety of of Enzalutamide with Trastuzumab in patients with HER2+ AR+ Metastatic or Locally Advanced Breast Cancer

Phase 1

• Conditions: Subjects with HER2+ AR+ Metastatic or Locally Advanced Breast Cancer; MedDRA version: 17.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 17.0Level: LLTClassification code 10072740Term: Locally advanced breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-000093-29-IT
• Lead Sponsor: Astellas Pharma Global Development, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-20
• Last Update Posted: 12 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

Please refer to protocol for principal inclusion criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

Please refer to protocol for principal exlusion criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of enzalutamide with trastuzumab in evaluable subjects with human epidermal growth factor receptor 2 positive (HER2+), androgen receptor positive (AR+) and estrogen receptor negative (ER-)/progesterone receptor negative (PgR-), metastatic or locally advanced breast cancer;Secondary Objective: To evaluate the following efficacy measures:<br>o Best Overall Response Rate (BORR)<br>o Overall Response Rate (ORR) at 24 weeks<br>o Progression Free Survival (PFS)<br>o Time to Progression (TTP)<br>o Duration of Response (DOR)<br>o Time to Response (TTR)<br>o To evaluate safety and tolerability.;Primary end point(s): CBR defined as the proportion of subjects with best objective response of CR, PR or SD at = 24 weeks according to RECIST 1.1 criteria.;Timepoint(s) of evaluation of this end point: up to 2 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Overall response rate (CR+PR) according to RECIST 1.1 criteria<br>;Timepoint(s) of evaluation of this end point: up to 2 years