The University of Texas Health Science Center at San Antonio
This study aims to evaluate the safety of avasopasem in combination with CDK 4/6 inhibitor and hormonal therapy in women with metastatic hormone receptor positive breast cancer, and to see if the addition of avasopasem improves the effectiveness of a CDK 4/6 inhibitor and hormonal therapy.
This is a phase 1 non-randomized clinical trial of Avasopasem in patients with metastatic hormone receptor positive breast cancer with progression on first line therapy consisting of a CDK 4/6 inhibitor and hormonal therapy to determine the efficacy and safety of the addition of Avasopasem in patients with metastatic HR+ breast cancer with progression after first line treatment with hormonal therapy (an AI or fulvestrant) and a CDK 4/6 inhibitor (ribociclib or abemaciclib). Each treatment cycle will be 28 days and tumor assessment by imaging with CT scans of the chest, abdomen and pelvis will…
Inclusion Criteria: * Histologically confirmed diagnosis of HR+, HER2 negative metastatic breast cancer. * Estrogen receptor (ER) and/or progesterone receptor (PR) expression positivity is defined as at least 10% of tumor cells nuclei positive by immunohistochemistry in the sample on testing. * HER2 negative: defined as IHC staining of 0 or 1+. If HER2 overexpression is equivocal by IHC, defined as 2+, the tumor must be non-gene amplified by FISH (ratio \<2 and HER2 copy number \<4). * Progression on treatment with a CDK 4/6 inhibitor and hormonal therapy in the metastatic setting * The CD…
Avasopasem has also been shown to exhibit both antitumor effects as well as minimal toxicity. Participants are currently taking a CDK 4/6 inhibitor and hormonal therapy
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