Breast Cancer Clinical Trial

A Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Patients With Human Epidermal Growth Factor Receptor 2 Positive (HER2+), Androgen Receptor Positive (AR+) Metastatic or Locally Advanced Breast Cancer

Summary

The purpose of this study is to evaluate the efficacy of enzalutamide with trastuzumab in patients with HER2+ AR+ metastatic or locally advanced breast cancer.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

The subject has histologically or cytologically proven adenocarcinoma of the breast that is HER2+
The subject has AR+ breast cancer
The subject has metastatic disease or has locally advanced disease that is not amendable to curative treatment
The subject has measurable disease or nonmeasurable, evaluable disease per RECIST 1.1. (NOTE: pleural effusions, ascites or other third fluid space are not evaluable diseases per RECIST 1.1).
The subject has received at least 1 line of therapy in the metastatic or locally advanced disease setting. The subject has been documented to have progressed by determination of the investigator on a regimen containing an anti-HER2 agent as the most recent regimen or the most recent anti-HER2 regimen was discontinued for any toxicity, with the exception of a cardiotoxicity.
The subject has adequately recovered from toxicities due to prior therapy.
The subject has an Eastern Cooperative Oncology Group performance (ECOG) status ≤ 1 at Screening and Day 1
The subject has available at the site a representative, formalin-fixed, paraffin-embedded, tumor specimen that enabled the definitive diagnosis of breast cancer with adequate viable tumor cells in a tissue block (preferred) or ≥ 10 (20 preferred) freshly cut, unstained, serial slides and the associated pathology report

Exclusion Criteria:

The subject has a severe concurrent disease, infection, or comorbidity that would make the subject inappropriate for enrollment.
The subject has current or previously treated brain metastasis or active leptomeningeal disease. Brain imaging is required during screening in all subjects to exclude the presence of unequivocal central nervous system disease.

The subject has a history of a non-breast cancer malignancy with the following exceptions:

The subject with a previous history of a non-invasive carcinoma is eligible if he/she has had successful curative treatment any time prior to Screening.
For all other malignancies, the subject is eligible if they have undergone potentially curative therapy and they have been considered disease free for at least 5 years prior to Screening.
The subject has a history of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma).
The subject has a history of loss of consciousness, cerebrovascular accident, or transient ischemic attack within 12 months before the Day 1 visit.
The subject has had a hypoglycemic episode requiring medical intervention while on insulin (or other anti-diabetic) treatment within 12 months before Day 1.
The subject had a major surgical procedure, substantial open biopsy, or significant traumatic experience within 28 days before the Day 1 visit, or anticipation of need for major surgical procedure during the course of the study.
The subject has had palliative radiation therapy to bone metastases within 14 days prior to the Day 1 visit (side effects from radiation must be resolved).
The subject has received chemotherapy, immunotherapy, or any other systemic anticancer therapy, with the exception of anti-HER2 therapy (e.g., trastuzumab), within 14 days prior to the Day 1 visit.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

103

Study ID:

NCT02091960

Recruitment Status:

Active, not recruiting

Sponsor:

Astellas Pharma Global Development, Inc.

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There are 39 Locations for this study

See Locations Near You

Site US10051
Anaheim California, 92801, United States
Site US10028
Los Angeles California, 90048, United States
Site US10035
San Francisco California, 94115, United States
Site US10079
Fort Myers Florida, 33916, United States
Site US10074
Gainesville Florida, 32605, United States
Site US10081
Chicago Illinois, 60637, United States
Site US10004
Indianapolis Indiana, 46202, United States
Site US10070
Boston Massachusetts, 02215, United States
Site US10078
Saint Louis Missouri, 63110, United States
Site US10072
Cincinnati Ohio, 45242, United States
Site US10048
Pittsburgh Pennsylvania, 15213, United States
Site US10029
Knoxville Tennessee, 37909, United States
Site US10042
Nashville Tennessee, 37203, United States
Site US10077
Nashville Tennessee, 37232, United States
Site US10076
Fort Worth Texas, 76104, United States
Site US10082
Houston Texas, 77030, United States
Site BE32003
Edegem Antwerp, 2650, Belgium
Site BE32013
Brasschaat , 2930, Belgium
Site BE32016
Bruxelles , 1200, Belgium
Site BE32001
Charleroi , 6000, Belgium
Site BE32009
Leuven , 3000, Belgium
Site BE32007
Liege , 4000, Belgium
Site CA15022
Ottawa Ontario, K1H 8, Canada
Site CA15023
Toronto Ontario, M4N 3, Canada
Site CA15028
Regina Saskatchewan, S4T7T, Canada
Site CA15026
Saskatoon Saskatchewan, S7N 4, Canada
Site CA15001
Quebec , G1S 4, Canada
Site IT39005
Meldola Forli, 47014, Italy
Site IT39008
Lecce , 73100, Italy
Site IT39002
Milano , 20141, Italy
Site IT39003
Milan , 20132, Italy
Site IT39001
Sondrio , 23100, Italy
Site IT39021
Udine , 33100, Italy
Site ES34014
Pozuelo de Alarcon Madrid, 28223, Spain
Site ES34010
Barcelona , 08035, Spain
Site ES34013
Madrid , 28050, Spain
Site GB44003
Edinburgh , EH4 2, United Kingdom
Site GB44013
Manchester , M20 4, United Kingdom
Site GB44001
Nottingham , NG5 1, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

103

Study ID:

NCT02091960

Recruitment Status:

Active, not recruiting

Sponsor:


Astellas Pharma Global Development, Inc.

How clear is this clinincal trial information?

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