Exemestane + Entinostat for Advanced Breast Cancer

Recruiting at 762 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: National Cancer Institute (NCI)

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This randomized phase III trial studies exemestane and entinostat to see how well they work compared to exemestane alone in treating patients with hormone receptor-positive breast cancer that has spread to nearby tissue or lymph nodes (locally advanced) or another place in the body (metastatic). Estrogen can cause the growth of breast cancer cells. Endocrine therapy using exemestane may fight breast cancer by lowering the amount of estrogen the body makes. Entinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether exemestane is more effective with or without entinostat in treating breast cancer.

Research Team

Roisin M Connolly

Principal Investigator

ECOG-ACRIN Cancer Research Group

Eligibility Criteria

This trial is for adults with hormone receptor-positive breast cancer that's advanced or spread, who can swallow pills and have no known allergies to the drugs being tested. They should not be pregnant, breastfeeding, or have certain medical conditions that could affect participation. Only one prior chemo regimen for metastatic disease is allowed.

Inclusion Criteria

My breast cancer is advanced and cannot be cured with surgery or radiation.

I do not have, nor have I ever had, cancer spread to my brain.

My blood, liver, and kidney functions are all within normal ranges.

Exclusion Criteria

Patients must NOT be pregnant or breast-feeding

Treatment Details

Interventions

• Entinostat (Histone Deacetylase Inhibitor)
• Exemestane (Aromatase Inhibitor)

Trial Overview The study compares exemestane alone versus exemestane with entinostat in treating advanced breast cancer. Exemestane lowers estrogen to fight cancer; entinostat blocks enzymes needed by tumor cells to grow. The effectiveness of combining these treatments is being evaluated.

Participant Groups

Group I: Arm A (exemestane, entinostat) Experimental Treatment 8 Interventions

Patients receive exemestane PO QD on days 1-28 and entinostat PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI at baseline, at the end of cycle 3, every 3 cycles, at treatment discontinuation, and during follow-up, collection of blood samples at baseline and day 15 of cycle 1, and collection of archived tissue at baseline. Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1.

Group II: Arm B (exemestane, placebo) Placebo Group 8 Interventions

Patients receive exemestane as in Arm A and placebo PO on days 1, 8, 15, and 22. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT or MRI at baseline, at the end of cycle 3, every 3 cycles, at treatment discontinuation, and during follow-up, collection of blood samples at baseline and day 15 of cycle 1, and collection of archived tissue at baseline. Pre/perimenopausal female patients and all male patients also receive goserelin acetate SC on day 1.

Exemestane is already approved in Canada, Japan for the following indications:

Approved in Canada as Aromasin for:

• Early breast cancer
• Advanced breast cancer

Approved in Japan as Aromasin for:

• Early breast cancer
• Advanced breast cancer

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+