Study

Overview

Official Title: A Phase 3, Randomized, Open-label Study Comparing Efficacy and Safety of Sacituzumab Tirumotecan (sac-TMT, MK-2870) as a Monotherapy and in Combination with Pembrolizumab (MK-3475) Versus Treatment of Physician’s Choice in Participants With Previously Untreated Locally Recurrent Unresectable or Metastatic Triple-Negative Breast Cancer Expressing PD-L1 at CPS Less than 10 (TroFuse-011)

Researchers want to know if sacituzumab tirumotecan given alone or with pembrolizumab can treat triple negative breast cancer (TNBC). The main goal of this study is to learn if people treated with sacituzumab tirumotecan alone or with pembrolizumab live longer overall or without the cancer growing or spreading compared to people treated with chemotherapy.

Study Type:

Interventional

Study Phase:

Phase 3

Estimated Enrollment:

1000

Study Start Date:

March 2025

Estimated Study Completion Date:

May 2030

Estimated Primary Completion Date:

May 2030

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

CRITERIA

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Has locally recurrent unresectable or metastatic TNBC that cannot be treated with curative intent
Has not received systemic treatment for locally recurrent unresectable or metastatic breast cancer
Participants previously treated for early-stage breast cancer must have completed all prior therapy for early-stage breast cancer with curative intent at least 6 months before the first disease recurrence
Is a candidate for treatment with pembrolizumab and one of the TPC options: paclitaxel or nab-paclitaxel or gemcitabine + carboplatin
Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline with the exception of alopecia or vitiligo. Participants with endocrine-related AEs who are adequately treated with hormone replacement are eligible
Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load
Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

Has breast cancer amenable to treatment with curative intent
Has TNBC with evaluable tumor programmed death ligand 1 (PD-L1) expression at combined positive score (CPS) ≥10
Has received prior systemic therapy for treatment of locally recurrent unresectable or metastatic breast cancer
Has Grade ≥2 peripheral neuropathy
Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or severe corneal disease that prevents/delays corneal healing
Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease
Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Has skin only metastatic disease
Has advanced/metastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications
Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
Has known additional malignancy that is progressing or has required active treatment within the past 5 years
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable
Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Concurrent active Hepatitis B (defined as HBsAg positive and/or detectable HBV deoxyribonucleic acid (DNA)) and Hepatitis C virus (HCV) (defined as anti-HCV antibody (Ab) positive and detectable HCV ribonucleic acid (RNA)) infection
History of stem cell/solid organ transplant
Has not adequately recovered from major surgery or has ongoing surgical complications

Locations

United States Toll Free Number 1-800-770-4674

Mobile, Alabama, 36604
Chandler, Arizona, 85224
Los Angeles, California, 90095
San Francisco, California, 94158
New Haven, Connecticut, 06510
Altamonte Springs, Florida, 32701
West Palm Beach, Florida, 33401
Athens, Georgia, 30607
Boise, Idaho, 83712
Baltimore, Maryland, 21237
Baltimore, Maryland, 21239
Olney, Maryland, 20832
Silver Spring, Maryland, 20910
Minneapolis, Minnesota, 55407
Las Vegas, Nevada, 89119
Reno, Nevada, 89502
Hackensack, New Jersey, 07601
Albuquerque, New Mexico, 87109
Mineola, New York, 11501
New York, New York, 10016
Raleigh, North Carolina, 27607
Nashville, Tennessee, 37203
Dallas, Texas, 75231
El Paso, Texas, 79902
San Antonio, Texas, 78240
Norfolk, Virginia, 23502

Canada Study Coordinator 514-891-6904

Results

No Study Results Posted

Study Detail

A Study of Sacituzumab Tirumotecan (sac-TMT, MK-2870) as Monotherapy and in Combination with Pembrolizumab (MK-3475) in Participants With Triple-Negative Breast Cancer (MK-2870-011/TroFuse-011)

Overview

Eligibility

CRITERIA

Locations

Results