Atezolizumab and Cobimetinib or Idasanutlin in Participants With Stage IV or Unresectable Recurrent Estrogen Receptor Positive Breast Cancer

Stopped early · Phase 1/Phase 2

Conditions studied: Stage III Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer, Estrogen Receptor-positive, HER2/Neu Negative

In brief

This phase I/II trial studies the side effects and best dose of idasanutlin when given together with atezolizumab, and to see how well atezolizumab and cobimetinib or idasanutlin work in treating participants with stage IV estrogen-receptor positive (ER+) breast cancer, or ER+ breast cancer that has come back (recurrent) and cannot be removed by surgery (unresectable). Monoclonal antibodies, such as atezolizumab, may interfere with the ability of tumor cells to grow and spread. Cobimetinib and idasanutlin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving atezolizumab with cobimetinib or atezolizumab with idasanutlin may work better in treating participants with estrogen-receptor positive breast cancer.

Key facts

Study ID

NCT03566485

Run by

Vanderbilt-Ingram Cancer Center

People needed

12

Starts

2018-07-10

Expected to finish

2020-12-10

Last updated by the study team

2021-08-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may not qualify if…

• Prior therapy with anti-PD-L1 and anti-PD1 antibodies, MEK inhibitors or MDM2 antagonists.
• No more than 3 lines of chemotherapy in the metastatic setting
• No concurrent anticancer therapy. Required washout from prior therapy:
• Endocrine therapy: no required wash-out
• Chemotherapy: 14 days
• Major surgery: 14 days (provided wound healing is adequate)
• Radiation: 7 days
• Investigational/Biologic Therapy (half -life ≤ 40 hours): 14 days
• Investigational/Biologic Therapy (half -life > 40 hours): 28 days
• Use of corticosteroids or immunosuppressive medication is exclusionary, except the following in the absence of active autoimmune disease:
• Subjects are permitted the use of corticosteroids with minimal systemic absorption (e.g. topical, ocular, intra-articular, intranasal, and inhaled);
• Systemic corticosteroids at physiologic doses ≤10 mg/day of prednisone or equivalent are permitted;
• Adrenal replacement steroid doses including doses > 10 mg daily prednisone are permitted;
• A brief (less than 3 weeks) course of corticosteroids for prophylaxis (e.g. CT scan premedication against contrast dye allergy) or for treatment of non-autoimmune conditions (e.g. delayed-type hypersensitivity reaction caused by a contact allergen) is permitted.
• Previous malignant disease other than breast cancer within the last 5 years, with the exception of basal or squamous cell carcinoma of the skin, cervical carcinoma in situ, or low-risk cancers considered curatively treated (i.e. complete remission achieved at least 2 years prior to first dose of study drugs AND additional therapy not required while receiving study treatment).
• All subjects with brain metastases, except those meeting the following criteria:
• Brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to enrollment
• No history of intracranial or spinal cord hemorrhage
• No evidence of interim CNS disease progression
• Metastasis to the midbrain, pons, and medulla
• No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable.
• Subjects must be either off steroids or on a stable or decreasing dose of ≤ 10 mg daily prednisone (or equivalent)
• Receipt of any organ transplantation including allogeneic stem-cell transplantation.
• Significant acute or chronic infections including, among others:
• Known history of testing positive for human immunodeficiency virus (HIV), or acquired immunodeficiency syndrome (AIDS).

Where it is running

• Vanderbilt-Ingram Cancer Center — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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