Clinical Trials /

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

NCT02091960

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: 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
  • 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

Clinical Trial IDs

  • ORG STUDY ID: 9785-CL-1121
  • SECONDARY ID: 2013-000093-29
  • NCT ID: NCT02091960

Conditions

  • HER2 Amplified
  • Advanced Breast Cancer
  • Human Epidermal Growth Factor Receptor 2 (HER2)

Interventions

DrugSynonymsArms
enzalutamideMDV3100, XtandiEnzalutamide and Trastuzumab
trastuzumabHerceptinEnzalutamide and Trastuzumab

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.

Trial Arms

NameTypeDescriptionInterventions
Enzalutamide and TrastuzumabExperimentaloral
  • enzalutamide
  • trastuzumab

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Clinical benefit rate (CBR)
Time Frame:≥ 24 weeks
Safety Issue:
Description: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

Measure:Overall response rate (CR+PR) according to RECIST 1.1 criteria
Time Frame:24 weeks
Safety Issue:
Description:
Measure:Best overall response rate according to RECIST 1.1 criteria
Time Frame:Up to 1 year
Safety Issue:
Description:
Measure:Progression free survival
Time Frame:Up to 1 year
Safety Issue:
Description: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
Measure:Time to progression
Time Frame:Up to 1 year
Safety Issue:
Description:Defined as the time from the first date of enzalutamide treatment until the date of disease progression per RECIST 1.1
Measure:Duration of response
Time Frame:Up to 1 year
Safety Issue:
Description:Defined as the time from the date of first documentation of response (CR or PR) until the date of disease progression
Measure:Time to response
Time Frame:Up to 1 year
Safety Issue:
Description:Defined as the time from the first date of enzalutamide treatment to initial CR or PR
Measure: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
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:Astellas Pharma Global Development, Inc.

Trial Keywords

  • Enzalutamide
  • Trastuzumab
  • Breast cancer
  • HER2
  • Androgen receptor positive
  • Xtandi

Last Updated

October 31, 2017