Title: Phase 1b/2 Study to Evaluate Antibody-Drug Conjugate Sacituzumab Govitecan in Combination With PARP Inhibitor Talazoparib in Patients With Metastatic Breast Cancer
Principal Investigator: Aditya Bardia, MD, Massachusetts General Hospital Cancer Center, Boston, Massachusetts
Description: Researchers are seeking to determine whether the combination of sacituzumab govitecan and talazoparib will help to stop the growth and spread of breast cancer. The currently recruiting, ongoing phase 1/2 trial is currently enrolling patients into phase 1. Sacituzumab govitecan is an antibody-drug conjugate and is believed to work by binding the antibody portion of the drug to the tumor(s) while the anticancer drug portion works to prevent the cancer cells from growing/spreading. Talazoparib belongs to a group of drugs called PARP inhibitors. Talazoparib is believed to work by inhibiting the PARP proteins from working in the cancer cells so that the cancer cannot fix its damaged DNA.
Patients enrolled into the experimental arm of the trial will receive a combination of sacituzumab govitecan with talazoparib, with sacituzumab govitecan administered on days 1 and 8 of a 21 day cycle and talazoparib administered daily.
Eligible patients are aged 18 and older with histologically confirmed stage IV metastatic breast cancer. Participants must have biopsy-proven ER-negative, PR-negative, HER2-negative invasive disease. Patients should have received previous treatment with no more than one prior therapeutic regimens for metastatic disease during dose-expansion (no limit on prior therapeutic regimens in dose-escalation). Both pre- and postmenopausal women are eligible to enroll and all patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Participants who have had anticancer therapy including targeted therapy or chemotherapy or radiotherapy within 2 weeks prior to entering the study, or those who have not recovered from adverse events (clinically significant grade 2 or higher adverse events) due to prior anticancer agents are not eligible for enrollment.
To review the full list of exclusion and inclusion criteria please refer to the reference.
Status: The study is ongoing and recruiting patients as of July 31, 2019.
This study is sponsored by Massachusetts General Hospital.
Clinicaltrials.gov. Study to Evaluate Sacituzumab Govitecan in Combination With Talazoparib in Patients With Metastatic Breast Cancer. NCT04039230. https://clinicaltrials.gov/ct2/show/NCT04039230. Accessed October 15, 2020.