HR-Positive HER2-Negative Breast Cancer Treatment Study

Clinical Trial Title

A study of multiple immunotherapy-based treatment combinations in hormone receptor (HR)-positive human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

Clinical Trial Protocol Description:

The purpose of this study is to compare the effects, good or bad, of cancer immunotherapy (CIT) combinations versus standard treatment, to find out which is better for participants with inoperable locally advanced or metastatic HR-positive, HER2-negative breast cancer who have progressed during or following treatment with a cyclin-dependent kinase (CDK) 4/6 inhibitor, such as palbociclib, ribociclib, or abemaciclib.

During Stage 1, participants will be assigned to receive standard treatment (endocrine therapy) or a cancer CIT combination (consisting of at least one CIT drug). Those who experience disease progression, loss of clinical benefit, or unacceptable toxicity may be eligible to receive a new triplet (3 drug) combination treatment in Stage 2.

Clinical Trial Eligibility Criteria:

In order to participate you must meet the following criteria:

  • Are a woman 18 years of age or older with metastatic or inoperable, locally advanced, histologically or cytologically confirmed invasive HR-positive HER2-negative breast cancer.
  • Have had disease progression during or after first- or second-line hormonal therapy with CDK4/6 inhibitor.
  • Are postmenopausal according to protocol-defined criteria.

You will be excluded from the study if any of the following criteria apply to you:

  • Have a positive HIV test or have active hepatitis B, C or tuberculosis.
  • have significant or uncontrolled comorbid disease as specified in the protocol.
  • Have a history of malignancy other than breast cancer within 2 years prior to screening except those with negligible risk of metastasis/death.

This is a partial list of inclusion and exclusion criteria.

Study Details

Clinical Trial Investigator

April T. Swoboda, MD

Contact Information

Rush Cancer Center Clinical Trials Office