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Active Not Recruiting
NCT04039230
Study to Evaluate Sacituzumab Govitecan in Combination With Talazoparib in Patients With Metastatic Breast Cancer.
Conditions: Breast Cancer
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 75
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Cancer Center Boston Massachusetts
Summary
This research is studying the effect of Antibody-Drug Conjugate Sacituzumab Govitecan in Combination with the Poly (Adenosine Diphosphate \[ADP\]-Ribose) Polymerase (PARP) Inhibitor Talazoparib in Patients with Metastatic Triple-Negative Breast Cancer.
Eligibility Criteria
Inclusion Criteria:
* Adult (≥ 18 years of age).
* Histologically confirmed stage IV (metastatic) breast cancer.
* Participants must have biopsy proven ER negative (ER-), PR negative (PR-), HER2 negative, invasive breast cancer, by AJCC 7th edition staging. ER, PR, and HER2 positivity would be determined per institutional (local) guidelines.
* Pre- and postmenopausal women are eligible.
* ECOG performance status = 0-1
* Measurable disease as per RECIST Version 1.1.
* Ability to understand and the willingness to sign a written informed consent document. Patient has signed the Informed Consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements.
* At least 2 weeks beyond treatment (chemotherapy, targeted therapy, immunotherapy, and/or radiation therapy) or major surgery and recovered from all acute toxicities (adverse events from prior anti-cancer agents need to be grade 1 or lower; grade 2 alopecia or peripheral neuropathy is permitted).
* At least 2 weeks beyond corticosteroids (however, low dose corticosteroids \
Source: ClinicalTrials.gov (NCT04039230). StuddyBuddy aggregates publicly available trial information.