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)
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)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests sacituzumab tirumotecan alone or with pembrolizumab for triple-negative breast cancer (TNBC). It is for people whose cancer has returned or spread and cannot be cured. Researchers will compare these drugs with chemotherapy to see if people live longer or go longer without cancer growing or spreading.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have TNBC that has returned nearby and cannot be removed by surgery, or has spread to other body parts, and cannot be cured.
- Have not had whole-body drug treatment for this returned or spreading breast cancer.
- If treated for early-stage breast cancer, have finished all treatment meant to cure it at least 6 months before the cancer first returned.
- Be able to receive pembrolizumab and one of these chemotherapy options: paclitaxel, nab-paclitaxel, or gemcitabine with carboplatin.
- Past cancer treatment side effects must be mild or back to your usual level. Hair loss, loss of skin color, and hormone problems controlled with replacement hormones are allowed.
- If you test positive for hepatitis B surface antigen, have taken antiviral drugs for at least 4 weeks, with no virus found on a blood test.
- If you have had hepatitis C, have no virus found on a blood test.
Who can't join
- Have a tumor PD-L1 test score called CPS of 10 or higher.
- Have moderate or worse nerve damage in the hands or feet.
- Have certain severe eye problems, including dry eyes, eyelid disease, or disease that slows healing of the eye's clear front layer.
- Have or have had inflammatory bowel disease, which causes swelling in the gut.
- Have serious, uncontrolled heart or blood vessel disease, including disease affecting blood flow to the brain.
- Have active cancer spread to the brain or spinal cord, or cancer in their lining. Previously treated brain cancer spread may be allowed if scans show it is stable.
- Have an illness where the immune system attacks the body that needed whole-body treatment in the past 2 years. Replacement hormones are allowed.
- Have current or suspected lung inflammation or scarring, or past lung inflammation not caused by infection that needed steroids.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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 * Has a history of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments * 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
Study sites (39)
AL
- USA Mitchell Cancer Institute ( Site 0090) · Mobile, AL 36604Study Coordinator · Study contact · 251-410-4924More trials in Mobile
AZ
- Ironwood Cancer & Research Centers ( Site 0036) · Chandler, AZ 85224Study Coordinator · Study contact · 623-312-3000More trials in Chandler
CA
- City of Hope ( Site 0097) · Duarte, CA 91010Study Coordinator · Study contact · 626-218-9845More trials in Duarte
- City of Hope Lennar Foundation Cancer Center ( Site 0099) · Irvine, CA 92618Study Coordinator · Study contact · 626-218-0720More trials in Irvine
- UCLA Department of Medicine - Hematology & Oncology ( Site 0047) · Los Angeles, CA 90095Study Coordinator · Study contact · 650-283-5067More trials in Los Angeles
- UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0016) · San Francisco, CA 94158Study Coordinator · Study contact · 415-353-7070More trials in San Francisco
CT
- Yale New Haven Hospital ( Site 0001) · New Haven, CT 06520More trials in New Haven
DC
- Washington Hospital Center ( Site 0098) · Washington D.C., DC 20010-2975Study Coordinator · Study contact · 202-877-8839More trials in Washington D.C.
FL
- AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0007) · Altamonte Springs, FL 32701Study Coordinator · Study contact · 407-303-2284More trials in Altamonte Springs
- Orlando Health Cancer Institute ( Site 0012) · Orlando, FL 32806Study Coordinator · Study contact · 321-841-8284More trials in Orlando
- Florida Cancer Specialists - East ( Site 7000) · West Palm Beach, FL 33401Study Coordinator · Study contact · 561-366-4100More trials in West Palm Beach
GA
- University Cancer & Blood Center, LLC ( Site 0023) · Athens, GA 30607Study Coordinator · Study contact · 706-353-2990More trials in Athens
ID
- St. Luke's Cancer Institute: Boise ( Site 0037) · Boise, ID 83712Study Coordinator · Study contact · 208-381-2711More trials in Boise
IL
- University of Illinois Cancer Center ( Site 0044) · Chicago, IL 60612Study Coordinator · Study contact · 312-996-1581More trials in Chicago
MD
- MedStar Franklin Square Medical Center ( Site 0031) · Baltimore, MD 21237Study Coordinator · Study contact · 443-777-7147More trials in Baltimore
- MedStar Good Samaritan Hospital ( Site 0079) · Baltimore, MD 21239Study Coordinator · Study contact · 443-777-7147More trials in Baltimore
- MedStar Southern Maryland Hospital Center ( Site 0100) · Clinton, MD 20735Study Coordinator · Study contact · 301-877-4673More trials in Clinton
- MedStar Montgomery Medical Center ( Site 0078) · Olney, MD 20832Study Coordinator · Study contact · 301-774-8882More trials in Olney
- Holy Cross Hospital ( Site 0091) · Silver Spring, MD 20910Study Coordinator · Study contact · 301-754-7552More trials in Silver Spring
MI
- Cancer & Hematology Centers of Western Michigan ( Site 0026) · Grand Rapids, MI 49503Study Coordinator · Study contact · 616-954-9800More trials in Grand Rapids
MN
- Allina Health Cancer Institute ( Site 0069) · Minneapolis, MN 55407More trials in Minneapolis
MS
- Hattiesburg Clinic Hematology/Oncology ( Site 0104) · Hattiesburg, MS 39401Study Coordinator · Study contact · 601-261-1700More trials in Hattiesburg
NC
- Rex Hematology Oncology Associates - Garner ( Site 0071) · Garner, NC 27529More trials in Garner
NJ
- John Theurer Cancer Center at Hackensack University Medical Center ( Site 0082) · Hackensack, NJ 07601Study Coordinator · Study contact · 551-996-5900More trials in Hackensack
NM
- New Mexico Oncology Hematology Consultants Ltd. ( Site 0019) · Albuquerque, NM 87109Study Coordinator · Study contact · 505-842-8171More trials in Albuquerque
NV
- Comprehensive Cancer Centers of Nevada ( Site 0015) · Las Vegas, NV 89106Study Coordinator · Study contact · 702-952-3350More trials in Las Vegas
- Renown Regional Medical Center ( Site 0005) · Reno, NV 89502Study Coordinator · Study contact · 775-982-5050More trials in Reno
NY
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0073) · Mineola, NY 11501Study Coordinator · Study contact · 516-663-9500More trials in Mineola
- Laura and Isaac Perlmutter Cancer Center ( Site 0003) · New York, NY 10016Study Coordinator · Study contact · 212-731-6126More trials in New York
TN
- SCRI Oncology Partners ( Site 7004) · Nashville, TN 37203Study Coordinator · Study contact · 615-329-7274More trials in Nashville
- Tennessee Oncology ( Site 0018) · Nashville, TN 37203Study Coordinator · Study contact · 877-836-6662More trials in Nashville
TX
- Texas Oncology - DFW ( Site 8007) · Dallas, TX 75231Study Coordinator · Study contact · 214-739-4175More trials in Dallas
- Texas Oncology - West Texas ( Site 8004) · El Paso, TX 79902Study Coordinator · Study contact · 915-747-4835More trials in El Paso
- Kelsey-Seybold Clinic - North Houston Campus ( Site 0096) · Houston, TX 77014Study Coordinator · Study contact · 713-239-4510More trials in Houston
- Kelsey-Seybold Clinic ( Site 0040) · Houston, TX 77025Study Coordinator · Study contact · 713-239-4510More trials in Houston
- Texas Oncology - San Antonio ( Site 8001) · San Antonio, TX 78240Study Coordinator · Study contact · 210-419-2608More trials in San Antonio
UT
- University of Utah, Huntsman Cancer Institute ( Site 0056) · Salt Lake City, UT 84112Study Coordinator · Study contact · 801-587-7000More trials in Salt Lake City
VA
- Virginia Oncology Associates (VOA) ( Site 8002) · Norfolk, VA 23502Study Coordinator · Study contact · 757-368-5033More trials in Norfolk
WA
- Fred Hutchinson Cancer Center ( Site 0042) · Seattle, WA 98109Study Coordinator · Study contact · 206-606-6329More trials in Seattle