Full TitleA Phase 2, Double Blinded, Randomized Controlled Trial of Evexomostat (SDX-7320) or Placebo in Combination with Eribulin for Patients with Metastatic Triple-Negative Breast Cancer and Metabolic Dysfunction: The ARETHA Study
The purpose of this study is to assess the safety and effectiveness of adding the drug evexomostat (SDX-7320) to standard eribulin chemotherapy in people with triple-negative breast cancer (TNBC) that has come back or spread despite treatment. In addition, the participants in this study have metabolic disorders such as high blood sugar and/or obesity. TNBC includes breast cancers that do not contain receptors for estrogen or progesterone and do not have the HER2 protein, so they cannot be treated with medications that target those proteins.
Metabolic disorders such as high blood sugar and/or obesity can accelerate the growth of breast cancers and possibly cause resistance to standard cancer treatments. Evexomostat has been shown to slow tumor growth, improve metabolic disorders, and was safe when given by itself in earlier phase I trials. This study will determine whether there is a benefit to adding evexomostat to standard chemotherapy.
Evexomostat works by blocking an enzyme that helps cancer cells multiply and also plays a role in improving metabolic disorders. Participants will receive one of these treatments:
- Evexomostat plus eribulin
- Eribulin plus a placebo (inactive drug)
SDX-7320 is given as a subcutaneous (under the skin) injection and eribulin is given intravenously (by vein).
Who Can Join
To be eligible for this study, patients must meet several requirements, including:
- Participants must have TNBC that has come back or spread despite prior treatment.
- Patients must have a hemoglobin A1C greater than 5.5 and/or a body mass index (BMI) of 30 or more.
- Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework.
- This study is for people age 18 or older.
For more information and to ask about eligibility for this study, please contact the office of Dr. Neil Iyengar at 646-888-4714.