A Pilot Study of the Combination of Entinostat With Capecitabine in High Risk Breast Cancer After Neo-adjuvant Therapy

PHASE1CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

January 29, 2019

Primary Completion Date

September 2, 2021

Study Completion Date

November 1, 2022

Conditions
Metastatic Breast CancerBreast Cancer
Interventions
DRUG

Entinostat

In metastatic breast cancer patients, entinostat will be taken orally starting at 3 mg per week and will increase to 5 mg per week in the absence of unacceptable side effects. The safe dose (when combined with capecitabine) will be confirmed in additional metastatic breast cancer patients and breast cancer patients with residual invasive disease following neoadjuvant chemotherapy and surgery.

DRUG

Capecitabine

In metastatic breast cancer patients, capecitabine will be taken by mouth starting at 800 mg/m2 twice a day for 14 days per cycle and increase to 1000 mg/m2 (for 14 days per cycle) in the absence of unacceptable side effects. The safe dose (when combined with capecitabine) will be confirmed in additional metastatic breast cancer patients and breast cancer patients with residual invasive disease following neoadjuvant chemotherapy and surgery.

Trial Locations (2)

14642

University of Rochester Medical Center, Rochester

22908

University of Virginia, Charlottesville

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Syndax Pharmaceuticals

INDUSTRY

lead

University of Virginia

OTHER