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A Phase II Clinical Trial of Evexomostat plus Eribulin for People with Triple-Negative

Breast Cancer

Phase 2 Randomized Control Trial of Evexomostat (SDX-7320) in Combination with Eribulin for Patients with Metastatic Triple-Negative Breast Cancer and Metabolic Dysfunction: The ARETHA Study


This study is being conducted at Memorial Sloan Kettering Cancer Center.

PURPOSE
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 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 1 trials. This study will determine whether there is a benefit to adding evexomostat to standard chemotherapy.


Evexomostat works by blocking an enzyme (MetAP2) 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)


Evexomostat is given as a subcutaneous (under the skin) injection once every 2 weeks and eribulin is given intravenously (by vein).



ELIGIBILITY

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 (HbA1) 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.




Contact

For more information and to ask about eligibility for this study, please contact the office of Dr. Neil Iyengar at 646-888-4714.


Breast Cancer Patient

Protocol

22-074

Phase

II

Disease Status

Metastatic

Investigator
Neil M. Iyengar

Co-Investigators

Tiffany A. Traina

Diseases

Breast Cancer

Clinical Site Locations - Greater NYC, Miami FL

Memorial Sloan Kettering Cancer Center

1275 York Avenue

New York NY 10065


Memorial Sloan Kettering Nonna’s Garden Foundation Center

650 Commack Rd.

Commack, NY, 11725


Memorial Sloan Kettering Monmouth

480 Red Hill Road

Middletown, NJ 07748


Memorial Sloan Kettering Westchester

500 Westchester Avenue

West Harrison, NY 10604


Memorial Sloan Kettering Basking Ridge

136 Mountain View Blvd.

Basking Ridge, NJ 07920


Memorial Sloan Kettering Bergen

225 Summit Avenue

Montvale NJ 07645


Miami Cancer Institute, Baptist Hospital

8900 North Kendall Drive

Miami, FL 33176


For More Details on the Aretha-1 Study
Visit Clinicaltrials.gov for full clinical study description.


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