Study to Evaluate Sacituzumab Govitecan in Combination With Talazoparib in Patients With Metastatic Breast Cancer.

NCT04039230 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 19-239
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Dose Limiting Toxicity

  2 years

Secondary Outcomes (4)

• Time-to-Tumor Response

  2 years

• Duration of response

  2 years

• Progression-Free Survival

  2 Years

• Overall Survival Rate

  2 years

Study Arms (1)

Sacituzumab Govitecan+Talazoparib

EXPERIMENTAL

* Sacituzumab Govitecan is administered on days 1 and 8 of a 21 day cycle. * Talazoparib is administered daily

Drug: Talazoparib; Drug: Sacituzumab Govitecan

Interventions

Sacituzumab Govitecan DRUG

Sacituzumab govitecan 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.

Sacituzumab Govitecan+Talazoparib

Talazoparib DRUG

Talazoparib belongs to a group of drugs called PARP inhibitors. PARP is a protein that is involved with repairing damaged DNA (the genetic material of cells). Talazoparib is believed to work by inhibiting (stopping) the PARP proteins from working in the cancer cells so that the cancer cannot fix its damaged DNA.

Sacituzumab Govitecan+Talazoparib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<20 mg prednisone or equivalent daily are permitted).
• Patient has adequate bone marrow and organ function as defined by the following laboratory values at screening:
• Absolute neutrophil count ≥1.5 × 109/L
• Platelets ≥100 × 109/L
• Hemoglobin ≥10.0 g/dL
• INR ≤1.5
• creatinine clearance ≥60 mL/min

You may not qualify if:

• Participants who have had anti-cancer therapy including targeted therapy or chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study, or those who have not recovered from adverse events (clinically significant grade 2 or higher adverse events; grade 2 alopecia or peripheral neuropathy is permitted) due to prior anti-cancer agents.
• Participants who have received prior irinotecan or ADC backbone with SN-38 or topoisomerase-1 inhibitor.
• Participants with progressive CNS metastatic disease. Patients with stable CNS metastasis would be eligible, provided mets radiologically stable for at least one month, and patient is not actively taking steroids (more than 20 mg of prednisone or equivalent dose).
• Current use of strong CYP3A inhibitors/inducers, or P-gp inhibitors within 7 days prior to randomization. For a list of strong CYP3A inhibitors/inducers and P-gp inhibitors, refer to Appendix C.
• Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
• Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality including any of the following:
• History of angina pectoris, symptomatic pericarditis, coronary artery bypass graft (CABG) or myocardial infarction within 6 months prior to study entry.
• Documented cardiomyopathy.
• History of cardiac failure, significant/symptomatic bradycardia, Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome or any of the following:
• Known risk to prolong the QT interval or induce Torsade's de Pointes.
• Uncorrected hypomagnesemia or hypokalemia.
• Systolic Blood Pressure (SBP) \>160 mmHg or \<90 mmHg.
• Bradycardia (heart rate \<50 at rest), by ECG or pulse.
• On screening, inability to determine the QTcF interval on the ECG (i.e.: unreadable or not interpretable) or QTcF \>450 screening ECG.
• HIV-positive participants on combination antiretroviral therapy are ineligible. These participants are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in participants receiving combination antiretroviral therapy when indicated.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Pfizer: collaborator

Study Sites (3)

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02115, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

talazoparib; sacituzumab govitecan

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Laura Spring, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: October 9, 2019
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: BCH - Contact the Technology \& Innovation Development Office at www.childrensinnovations.org or email TIDO@childrens.harvard.edu BIDMC - Contact the Beth Israel Deaconess Medical Center Technology Ventures Office at tvo@bidmc.harvard.edu BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu MGH - Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (3)