Pembrolizumab and Enobosarm in Treating Patients With Androgen Receptor Positive Metastatic Triple Negative Breast Cancer

Part of paid clinical trials in Corona, California.

Sponsor
City of Hope Medical Center
Study ID
NCT02971761
Phase
PHASE2
Status
Completed

Conditions

  • Androgen Receptor Positive
  • Estrogen Receptor Negative
  • HER2/Neu Negative
  • Metastatic Triple-Negative Breast Carcinoma
  • Progesterone Receptor Negative
  • Stage IV Breast Cancer AJCC v6 and v7

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Enobosarm — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pembrolizumab — BIOLOGICAL
    Given IV

Study Details

This phase II trial studies the side effects and how well pembrolizumab and enobosarm work in treating patients with androgen receptor positive triple negative breast cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Androgen can cause the growth of breast cancer cells. Hormone therapy using enobosarm may fight breast cancer by blocking the use of androgen by the tumor cells. Giving pembrolizumab and enobosarm may work better than pembrolizumab alone in treating patients with androgen receptor positive triple negative breast cancer.

Key Dates

Start date
Jun 1, 2017
Status verified
Feb 2024
Primary completion
Oct 28, 2020
Completion
Aug 16, 2022

Study Design

Enrollment
18 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (pembrolizumab, enobosarm)
    Patients receive pembrolizumab IV over 30 minutes on day 1 and enobosarm PO QD on days 1-21. Courses repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Response Rate (Complete Response or Partial Response) [ Time Frame: Up to 36 months ]

Locations (7)

FacilityCityStateZIPSite coordinators
City of Hope CoronaCoronaCalifornia92879-
City of Hope Medical CenterDuarteCalifornia91010-
City of Hope Antelope ValleyLancasterCalifornia93534-
City of Hope Mission HillsMission HillsCalifornia91345-
City of Hope Rancho CucamongaRancho CucamongaCalifornia91730-
City of Hope South PasadenaSouth PasadenaCalifornia91030-
City of Hope West CovinaWest CovinaCalifornia91790-

Find similar trials in Corona, CA

By research site
City of Hope Corona· Corona, CACity of Hope Medical Center· Duarte, CACity of Hope Antelope Valley· Lancaster, CACity of Hope Mission Hills· Mission Hills, CACity of Hope Rancho Cucamonga· Rancho Cucamonga, CACity of Hope South Pasadena· South Pasadena, CA

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