Actively Recruiting
Sacituzumab Govitecan In TNBC
Led by Massachusetts General Hospital · Updated on 2025-10-14
260
Participants Needed
5
Research Sites
480 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
G
Gilead Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research study is studying to evaluate sacituzumab govitecan for individuals with localized triple negative breast cancer (TNBC) The names of the study drugs involved in this study is: * Sacituzumab govitecan (SG) * Pembrolizumab (combination therapy with SG)
CONDITIONS
Official Title
Sacituzumab Govitecan In TNBC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female or male patients 18 years of age or older
- Diagnosed with invasive breast cancer that has not been treated before
- Biopsy confirmed triple negative breast cancer (ER-negative, PR-negative, HER2-negative) for all lesions
- Primary tumor must be at least 1 cm or larger by imaging
- Regional lymph node stages N0 to N2; any tumor size if nodes are positive
- No evidence of distant metastatic disease
- Premenopausal or postmenopausal women are eligible
- ECOG performance status of 0 or 1
- Able and willing to sign informed consent and comply with study requirements
- Adequate bone marrow and organ function as shown by lab tests (including ANC ≥ 1500/mm3, platelets ≥ 100,000/mm3, hemoglobin ≥ 9.0 g/dL, INR ≤ 1.5, creatinine <1.5 mg/dL or creatinine clearance ≥ 50 mL/min, liver enzymes <2.5 times normal, bilirubin ≤1.5 times normal or documented Gilbert's Syndrome)
You will not qualify if you...
- Inflammatory breast cancer or locally recurrent breast cancer
- Receiving systemic therapy for another cancer currently or within past 3 years
- Uncontrolled illness such as active infection, symptomatic heart failure, unstable angina, arrhythmia, or psychiatric/social conditions limiting study compliance
- Significant uncontrolled heart disease or abnormal heart rhythms including recent angina, heart attack, heart failure, cardiomyopathy, bradycardia, Long QT syndrome, or family history of sudden cardiac death
- Known risk factors for QT prolongation or Torsade's de Pointes
- Electrolyte imbalances such as uncorrected low magnesium or potassium
- Blood pressure over 160 mmHg or under 90 mmHg
- Resting heart rate under 50 beats per minute
- Pregnant or breastfeeding women
- Known HIV-positive on combination antiretroviral therapy
- Known history of hepatitis B or C infection
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Actively Recruiting
2
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
3
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
Massachusetts General Hospital - North Shore Cancer Center
Danvers, Massachusetts, United States, 01923
Actively Recruiting
5
Massachusetts General Hospital at Newton-Wellesley Hospital
Newton, Massachusetts, United States, 02462
Actively Recruiting
Research Team
L
Laura Spring, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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