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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02091960
First Posted: March 19, 2014
Last Update Posted: November 2, 2017
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. Read our disclaimer for details.
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
  Purpose
The purpose of this study is to evaluate the efficacy of enzalutamide with trastuzumab in subjects with HER2+ AR+ metastatic or locally advanced breast cancer.

Condition Intervention Phase
HER2 Amplified Advanced Breast Cancer Human Epidermal Growth Factor Receptor 2 (HER2) Drug: enzalutamide Drug: trastuzumab Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Open-label Study to Assess the Efficacy and Safety of Enzalutamide With Trastuzumab in Subjects With HER2+ AR+ Metastatic or Locally Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):

Primary Outcome Measures:
  • Clinical benefit rate (CBR) [ Time Frame: ≥ 24 weeks ]
    Defined as the proportion of evaluable subjects with best objective response of confirmed complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, or prolonged stable disease (SD) (≥ 24 weeks)


Secondary Outcome Measures:
  • Overall response rate (CR+PR) according to RECIST 1.1 criteria [ Time Frame: 24 weeks ]
  • Best overall response rate according to RECIST 1.1 criteria [ Time Frame: Up to 1 year ]
  • Progression free survival [ Time Frame: Up to 1 year ]
    Defined as the time from the date of first dose of enzalutamide (Study Day 1) until the date of disease progression per RECIST 1.1, or death from any cause on study, whichever occurs first

  • Time to progression [ Time Frame: Up to 1 year ]
    Defined as the time from the first date of enzalutamide treatment until the date of disease progression per RECIST 1.1

  • Duration of response [ Time Frame: Up to 1 year ]
    Defined as the time from the date of first documentation of response (CR or PR) until the date of disease progression

  • Time to response [ Time Frame: Up to 1 year ]
    Defined as the time from the first date of enzalutamide treatment to initial CR or PR

  • Safety assessed by physical examinations, vital signs, laboratory assessments, electrocardiograms, left ventricular ejection fraction (LVEF) by echocardiogram or multi-gated acquisition scan (MUGA), and evaluation of adverse events [ Time Frame: Up to 1 year until progression per RECIST 1.1, study withdrawal or death from any cause on study, whichever occurs first ]

Enrollment: 103
Actual Study Start Date: August 28, 2014
Estimated Study Completion Date: June 2018
Primary Completion Date: February 28, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enzalutamide and Trastuzumab
oral
Drug: enzalutamide
oral
Other Names:
  • MDV3100
  • Xtandi
Drug: trastuzumab
Intravenous infusion (IV) or subcutaneous if it is standard of care within a country
Other Name: Herceptin

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

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): NCT02091960


  Show 38 Study Locations
Sponsors and Collaborators
Astellas Pharma Global Development, Inc.
Medivation, Inc.
Investigators
Study Director: Executive Medical Director Astellas Pharma Global Development, Inc.
  More Information

Responsible Party: Astellas Pharma Global Development, Inc.
ClinicalTrials.gov Identifier: NCT02091960     History of Changes
Other Study ID Numbers: 9785-CL-1121
2013-000093-29 ( EudraCT Number )
First Submitted: March 18, 2014
First Posted: March 19, 2014
Last Update Posted: November 2, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. ):
Enzalutamide
Trastuzumab
Breast cancer
HER2
Androgen receptor positive
Xtandi

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Androgens
Antineoplastic Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs