Sacituzumab Tirumotecan (MK-2870) Plus Pembrolizumab Versus TPC in TNBC Who Did Not Achieve pCR (MK-2870-012)
A Phase 3, Randomized, Open-label, Study to Compare the Efficacy and Safety of Adjuvant MK-2870 in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice (TPC) in Participants With Triple-Negative Breast Cancer (TNBC) Who Received Neoadjuvant Therapy and Did Not Achieve a Pathological Complete Response (pCR) at Surgery
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 (MK-2870) plus pembrolizumab after surgery for triple-negative breast cancer. It is for people who still had cancer in tissue removed during surgery after getting treatment before surgery. The study compares the drug pair with pembrolizumab alone or with capecitabine to see which is safer and better at keeping invasive cancer from returning.
This is a randomized, open-label study comparing the efficacy and safety of adjuvant sacituzumab tirumotecan (MK-2870) in combination with pembrolizumab compared to treatment of physician's choice (TPC) in participants with triple-negative breast cancer (TNBC) who received neoadjuvant therapy and did not achieve a pathological complete response (pCR) at surgery. The primary objective is to compare sacituzumab tirumotecan plus pembrolizumab to TPC (pembrolizumab or pembrolizumab plus capecitabine) with respect to invasive disease-free survival (iDFS) per investigator assessment. It is hypothesized that sacituzumab tirumotecan plus pembrolizumab is superior to TPC with respect to iDFS per investigator assessment.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have triple-negative breast cancer confirmed by the study lab, with no signs that cancer has returned or spread.
- Had pembrolizumab with the required chemotherapy before surgery, but cancer was still found in the tissue removed.
- Had all visible cancer removed from the breast and/or nearby lymph nodes and have recovered from surgery.
- Can keep taking pembrolizumab and join a study treatment group within 16 weeks after surgery.
- Have finished radiation after surgery, if needed, and recovered. Provide tissue from surgery for study testing.
- Can do daily activities with little or no help. Side effects from past cancer treatment must be mild or back to their earlier level, except hair loss.
- Are not pregnant or breastfeeding and agree to the required birth control, sperm donation, and breastfeeding rules during and after treatment.
- If you have HIV, it must be well controlled with medicine. If you have hepatitis B, you must have taken antiviral medicine for at least 4 weeks and have no detectable virus before group assignment.
Who can't join
- Have an inherited BRCA gene change that makes you eligible for olaparib after surgery, where that drug is approved and available.
- Have severe nerve damage, severe eye problems listed in the study, or a history of inflammatory bowel disease, such as Crohn’s disease.
- Have serious, uncontrolled heart or brain blood vessel disease, including certain problems in the past 6 months.
- Have had certain antibody-linked cancer drugs or immune treatments, or cancer drug treatment after surgery. Some recent cancer treatments, radiation, and experimental treatments also rule out joining.
- Take certain medicines that affect how the body processes study treatment and cannot stop them, or had a live vaccine within 30 days before treatment.
- Have another cancer that is growing or needed treatment within 5 years, a weak immune system, certain immune-suppressing medicines, or an autoimmune disease needing body-wide treatment within 2 years.
- Have current lung inflammation, past lung inflammation that needed steroids, or an active infection needing body-wide treatment.
- Have both active hepatitis B and C, HIV with a history of Kaposi’s sarcoma or Multicentric Castleman’s disease, or a past tissue or organ transplant from another person.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Has centrally confirmed TNBC, as defined by the most recent American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines * Has no evidence of locoregional or distant relapse, as assessed by the treating physician * Had neoadjuvant treatment based on the KEYNOTE-522 regimen (pembrolizumab with carboplatin/taxanes and pembrolizumab with anthracycline-based chemotherapy) followed by surgery according to National Comprehensive Cancer Network (NCCN) treatment guidelines for TNBC * Had adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes and have adequately recovered from surgery * Has non-pathologic complete response at surgery * Is able to continue on adjuvant pembrolizumab * Randomization must be conducted within 16 weeks from surgical resection * Completed adjuvant radiation therapy (if indicated) and recovered before randomization * Has provided tissue from the surgical resection for central laboratory determination of trophoblast cell surface antigen 2 (TROP2) status * If capable of producing sperm, the participant agrees to the following during the intervention period and for at least the time needed to eliminate each study intervention after the last dose of study intervention (120 days for sacituzumab tirumotecan and 95 days for capecitabine \[no restriction for pembrolizumab\]): agrees to refrain from donating sperm AND is either abstinent and agrees to remain abstinent or uses highly effective contraception * For females (assigned at birth), is not pregnant or breastfeeding and ≥1 of the following applies: is not a participant of childbearing potential (POCBP) OR is a POCBP and uses highly effective contraception after the last dose of study intervention (210 days for sacituzumab tirumotecan, 120 days for pembrolizumab, and 185 days for capecitabine). Abstains from breastfeeding during the study intervention period and for at least 120 days after study intervention * Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline (except alopecia) * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART) * An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before first dose of study treatment * Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B birus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization Exclusion Criteria: * Has a known germline breast cancer gene (BRCA) mutation (deleterious or suspected deleterious) and is eligible for adjuvant therapy with olaparib where olaparib is approved and available * Has Grade \>2 peripheral neuropathy * 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 (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea) * Has uncontrolled, significant cardiovascular disease or cerebrovascular disease including New York Heart Association Class III or IV congestive heart failure, unstable angina, myocardial infarction, uncontrolled symptomatic arrhythmia, prolongation of QTcF interval to \>480 ms, and/or other serious cardiovascular and cerebrovascular diseases within 6 months prior to study intervention * Received prior treatment with a trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) or a topoisomerase I inhibitor-containing ADC * Received anticancer therapy in the adjuvant phase including but not limited to chemotherapy, small molecule anticancer drugs, poly (adenosine diphosphate ribose) polymerase (PARP) inhibitors, ADCs, and/or immunotherapy, with the exception of adjuvant radiation therapy * Is currently receiving a strong inducer/inhibitor of cytochrome P450 3A4 (CYP3A4) that cannot be discontinued for the duration of the study. The required washout period before starting sacituzumab tirumotecan is 2 weeks * Except for pembrolizumab as neoadjuvant therapy for early-stage TNBC: received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein-4 \[CTLA-4\], OX-40 \[cluster of differentiation (CD) 134\], or CD137) * Except for chemotherapy as neoadjuvant therapy for early-stage TNBC: Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization * Received prior radiotherapy within 3 weeks of start of study intervention or required corticosteroids for radiation related toxicities that cannot be discontinued before the first dose of study intervention * Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has known additional malignancy that is progressing or has required active treatment within the past 5 years * Has diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study medication * Has active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed * Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has concurrent active hepatitis B and hepatitis C virus infection * Has history of allogeneic tissue/solid organ transplant
Study sites (93)
AL
- Infirmary Cancer Care ( Site 0001) · Mobile, AL 36607Study Coordinator · Study contact · 251-435-2273More trials in Mobile
AZ
- Ironwood Cancer & Research Centers-Research ( Site 0054) · Chandler, AZ 85224Study Coordinator · Study contact · 480-821-2838More trials in Chandler
CA
- MemorialCare Orange Coast Medical Center ( Site 9501) · Fountain Valley, CA 92708Study Coordinator · Study contact · 714-378-7000More trials in Fountain Valley
- Scripps Cancer Center ( Site 0052) · La Jolla, CA 92037Study Coordinator · Study contact · 800-727-4777More trials in La Jolla
- Cancer and Blood Specialty Clinic ( Site 0008) · Los Alamitos, CA 90720More trials in Los Alamitos
- Kaiser Permanente - Oakland ( Site 0079) · Oakland, CA 94611Study Coordinator · Study contact · 877-642-4691More trials in Oakland
- Profound Research LLC ( Site 0105) · Oceanside, CA 92056Study Coordinator · Study contact · 760-826-2020More trials in Oceanside
- Kaiser Permanente - Roseville ( Site 0081) · Roseville, CA 95661Study Coordinator · Study contact · 877-642-4691More trials in Roseville
- Kaiser Permanente - San Francisco ( Site 0080) · San Francisco, CA 94115Study Coordinator · Study contact · 877-642-4691More trials in San Francisco
- Kaiser Permanente - Santa Clara ( Site 0082) · Santa Clara, CA 95051Study Coordinator · Study contact · 877-642-4691More trials in Santa Clara
- Providence Medical Foundation ( Site 9543) · Santa Rosa, CA 95403Study Coordinator · Study contact · 707-528-1050More trials in Santa Rosa
- Kaiser Permanente Vallejo Medical Center ( Site 0060) · Vallejo, CA 94589Study Coordinator · Study contact · 877-642-4691More trials in Vallejo
- Kaiser Permanente - Walnut Creek ( Site 0078) · Walnut Creek, CA 94596Study Coordinator · Study contact · 877-642-4691More trials in Walnut Creek
- Bass Medical Group ( Site 0089) · Walnut Creek, CA 94598More trials in Walnut Creek
CO
- Cancer Centers of Colorado St. Mary's Regional Hospital ( Site 0046) · Grand Junction, CO 81501Study Coordinator · Study contact · 970-298-7500More trials in Grand Junction
CT
- University of Connecticut Health Center ( Site 0128) · Farmington, CT 06030Study Coordinator · Study contact · 860-679-2100More trials in Farmington
- Yale Cancer Center ( Site 0053) · New Haven, CT 06510Study Coordinator · Study contact · 203-688-4242More trials in New Haven
DE
- Helen F. Graham Cancer Center & Research Institute ( Site 0018) · Newark, DE 19713Study Coordinator · Study contact · 302-366-1200More trials in Newark
FL
- AdventHealth Altamonte Springs ( Site 0125) · Altamonte Springs, FL 32701Study Coordinator · Study contact · 407-834-5151More trials in Altamonte Springs
- Orlando Health Cancer Institute ( Site 0030) · Orlando, FL 32806Study Coordinator · Study contact · 321-843-8370More trials in Orlando
- Comprehensive Hematology Oncology ( Site 0091) · St. Petersburg, FL 33709Study Coordinator · Study contact · 727-344-6569More trials in St. Petersburg
- Cleveland Clinic Martin North Hospital ( Site 0114) · Stuart, FL 34994Study Coordinator · Study contact · 772-419-2146More trials in Stuart
GA
- Archbold Memorial Hospital-Lewis Hall Singletary Oncology Center ( Site 0040) · Thomasville, GA 31792More trials in Thomasville
IL
- Illinois Cancer Specialists (ICS) ( Site 8010) · Arlington Heights, IL 60005Study Coordinator · Study contact · 847-259-4482More trials in Arlington Heights
- Southern Illinois Hospital Services ( Site 9547) · Carterville, IL 62918Study Coordinator · Study contact · 618-549-0721More trials in Carterville
- Orchard Healthcare Research Inc. ( Site 0014) · Skokie, IL 60077Study Coordinator · Study contact · 224-534-7580More trials in Skokie
IN
- Northwest Cancer Center - Dyer Clinic ( Site 0097) · Dyer, IN 46311Study Coordinator · Study contact · 615-785-5914More trials in Dyer
- Parkview Research Center at Parkview Regional Medical Center ( Site 0011) · Fort Wayne, IN 46845Study Coordinator · Study contact · 260-266-6313More trials in Fort Wayne
KS
- Cancer Center of Kansas ( Site 0004) · Wichita, KS 67214More trials in Wichita
KY
- Saint Elizabeth Medical Center Edgewood-Cancer Care Center ( Site 0044) · Edgewood, KY 41017Study Coordinator · Study contact · 859-301-4000More trials in Edgewood
LA
- CHRISTUS St. Frances Cabrini Hospital Center for Cancer Care ( Site 0109) · Alexandria, LA 71301Study Coordinator · Study contact · 318-528-6976More trials in Alexandria
- Ochsner LSU Health - Monroe Medical Center, Family Medicine Clinic ( Site 0063) · Monroe, LA 71202More trials in Monroe
- Louisiana State University Health Sciences Shreveport ( Site 0029) · Shreveport, LA 71103Study Coordinator · Study contact · 318-813-1429More trials in Shreveport
MD
- Holy Cross Hospital ( Site 0069) · Silver Spring, MD 20910Study Coordinator · Study contact · 301-754-7552More trials in Silver Spring
MI
- University of Michigan ( Site 0103) · Ann Arbor, MI 48109Study Coordinator · Study contact · 800-865-1125More trials in Ann Arbor
- Henry Ford Health ( Site 0010) · Detroit, MI 48202Study Coordinator · Study contact · 313-598-2556More trials in Detroit
- Profound Research LLC ( Site 0074) · Royal Oak, MI 48073More trials in Royal Oak
MN
- Metro-Minnesota Community Clinical Oncology ( Site 0031) · Saint Louis Park, MN 55426Study Coordinator · Study contact · 952-993-3252More trials in Saint Louis Park
MO
- SSM Health Cancer Care - Fenton ( Site 0088) · Fenton, MO 63026More trials in Fenton
- Lake Regional Hospital ( Site 0009) · Osage Beach, MO 65065Study Coordinator · Study contact · 573-302-2772More trials in Osage Beach
- Siteman Cancer Center ( Site 0099) · St Louis, MO 63108Study Coordinator · Study contact · 314-362-0263More trials in St Louis
MS
- University of Mississippi Medical Center ( Site 0043) · Jackson, MS 39216Study Coordinator · Study contact · 601-984-5590More trials in Jackson
NC
- Levine Cancer Institute ( Site 0083) · Charlotte, NC 28204Study Coordinator · Study contact · 980-442-3130More trials in Charlotte
- Cape Fear Valley Health System ( Site 0136) · Fayetteville, NC 28304Study Coordinator · Study contact · 472-210-8847More trials in Fayetteville
ND
- Sanford Cancer Center Bismarck ( Site 0058) · Bismarck, ND 58501Study Coordinator · Study contact · 701-323-5741More trials in Bismarck
- Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 0056) · Fargo, ND 58102Study Coordinator · Study contact · 701-234-2000More trials in Fargo
- Altru Cancer Center ( Site 0104) · Grand Forks, ND 58201Study Coordinator · Study contact · 701-780-5451More trials in Grand Forks
NM
- New Mexico Oncology Hematology Consultants Ltd. ( Site 0090) · Albuquerque, NM 87109Study Coordinator · Study contact · 505-842-8171More trials in Albuquerque
- CHRISTUS St. Vincent Regional Cancer Center ( Site 0118) · Santa Fe, NM 87505Study Coordinator · Study contact · 505-913-8953More trials in Santa Fe
NV
- Optum Care Cancer Center ( Site 9535) · Las Vegas, NV 89102Study Coordinator · Study contact · 702-724-8787More trials in Las Vegas
- Comprehensive Cancer Centers of Nevada - Peak ( Site 0047) · Las Vegas, NV 89128Study Coordinator · Study contact · 702-609-9427More trials in Las Vegas
NY
- The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0135) · New York, NY 10011Study Coordinator · Study contact · 212-604-6000More trials in New York
- Icahn School of Medicine at Mount Sinai ( Site 0123) · New York, NY 10029Study Coordinator · Study contact · 212-241-3300More trials in New York
- Memorial Sloan Kettering Cancer Center ( Site 0067) · New York, NY 10065Study Coordinator · Study contact · 212-639-2000More trials in New York
- Clinical Research Alliance ( Site 0086) · Westbury, NY 11590Study Coordinator · Study contact · 516-734-8906More trials in Westbury
OH
- Cleveland Clinic - Mercy Hospital ( Site 0057) · Canton, OH 44708Study Coordinator · Study contact · 330-489-1274More trials in Canton
- Tri-County Hematology & Oncology Associates, Inc. ( Site 0076) · Massillon, OH 44646Study Coordinator · Study contact · 330-478-0001More trials in Massillon
- Taylor Cancer Research Center ( Site 9500) · Maumee, OH 43537Study Coordinator · Study contact · 567-402-4501More trials in Maumee
- Genesis Healthcare System ( Site 0025) · Zanesville, OH 43701Study Coordinator · Study contact · 740-454-5271More trials in Zanesville
OK
- Hightower Clinical, LLC ( Site 0085) · Oklahoma City, OK 73102More trials in Oklahoma City
- Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0041) · Tulsa, OK 74146Study Coordinator · Study contact · 918-505-3200More trials in Tulsa
OR
- Providence Portland Medical Center ( Site 0116) · Portland, OR 97213Study Coordinator · Study contact · 503-215-1979More trials in Portland
- Providence Oncology and Hematology Care Clinic - Westside ( Site 0126) · Portland, OR 97225Study Coordinator · Study contact · 503-215-1979More trials in Portland
PA
- Sidney Kimmel Cancer Center at Jefferson ( Site 0049) · Philadelphia, PA 19107Study Coordinator · Study contact · 215-955-8874More trials in Philadelphia
- Cancer Care Associates Of York ( Site 9517) · York, PA 17403Study Coordinator · Study contact · 717-741-9229More trials in York
SD
- Sanford Cancer Center ( Site 0059) · Sioux Falls, SD 57104Study Coordinator · Study contact · 605-328-8000More trials in Sioux Falls
TN
- West Cancer Center and Research Institute ( Site 0084) · Germantown, TN 38138Study Coordinator · Study contact · 901-683-0055More trials in Germantown
- Baptist Cancer Center ( Site 0101) · Memphis, TN 38120Study Coordinator · Study contact · 901-226-3077More trials in Memphis
- One Oncology - Tennessee Oncology ( Site 0098) · Nashville, TN 37203Study Coordinator · Study contact · 615-986-4350More trials in Nashville
- SCRI Oncology Partners ( Site 7000) · Nashville, TN 37203Study Coordinator · Study contact · 615-329-7274More trials in Nashville
- Tennessee Oncology ( Site 0111) · Nashville, TN 37203Study Coordinator · Study contact · 615-986-4350More trials in Nashville
- Nashville General Hospital ( Site 0072) · Nashville, TN 37208More trials in Nashville
- Vanderbilt Health One Hundred Oaks ( Site 0042) · Nashville, TN 37212Study Coordinator · Study contact · 800-811-8480More trials in Nashville
TX
- Hendrick Medical Center ( Site 0117) · Abilene, TX 79601Study Coordinator · Study contact · 325-670-2000More trials in Abilene
- Harrington Cancer Center ( Site 0061) · Amarillo, TX 79106Study Coordinator · Study contact · 806-359-4673More trials in Amarillo
- Texas Oncology - DFW ( Site 8000) · Dallas, TX 75246Study Coordinator · Study contact · 214-370-1000More trials in Dallas
- Parkland Health & Hospital System ( Site 0096) · Dallas, TX 75390Study Coordinator · Study contact · 214-645-4673More trials in Dallas
- University of Texas Southwestern Medical Center ( Site 0032) · Dallas, TX 75390Study Coordinator · Study contact · 214-645-4673More trials in Dallas
- Texas Oncology - Northeast Texas ( Site 8005) · Flower Mound, TX 75028Study Coordinator · Study contact · 972-537-4100More trials in Flower Mound
- John Peter Smith Hospital ( Site 0106) · Fort Worth, TX 76104Study Coordinator · Study contact · 817-702-8049More trials in Fort Worth
- Oncology Consultants P.A. ( Site 0107) · Houston, TX 77030Study Coordinator · Study contact · 713-600-0900More trials in Houston
- Laguna Clinical Research Associates LLC ( Site 0068) · Laredo, TX 78041Study Coordinator · Study contact · 956-724-8543More trials in Laredo
- Mays Cancer Center ( Site 0122) · San Antonio, TX 78229Study Coordinator · Study contact · 210-450-1000More trials in San Antonio
- The University of Texas Health Science Center at Tyler dba UT Health East Texas HOPE Cancer Center ( Site 0055) · Tyler, TX 75701Study Coordinator · Study contact · 903-592-6152More trials in Tyler
- Texas Oncology - Gulf Coast ( Site 8009) · Webster, TX 77598Study Coordinator · Study contact · 281-332-7505More trials in Webster
UT
- Intermountain Medical Center ( Site 0113) · Murray, UT 84107Study Coordinator · Study contact · 801-507-3630More trials in Murray
VA
- Mary Washington Hospital ( Site 0129) · Fredericksburg, VA 22405Study Coordinator · Study contact · 540-300-6182More trials in Fredericksburg
- Hematology Oncology Associates of Fredericksburg ( Site 9550) · Fredericksburg, VA 22408Study Coordinator · Study contact · 540-371-0079More trials in Fredericksburg
- Bon Secours Memorial Regional Medical Center-Oncology Research Department ( Site 0020) · Midlothian, VA 23114Study Coordinator · Study contact · 804-893-8717More trials in Midlothian
- Virginia Oncology Associates (VOA) ( Site 8008) · Norfolk, VA 23502Study Coordinator · Study contact · 646-694-8125More trials in Norfolk
- Virginia Cancer Institute ( Site 0034) · Richmond, VA 23229Study Coordinator · Study contact · 804-287-3000More trials in Richmond
WA
- Northwest Medical Specialties, PLLC ( Site 0093) · Tacoma, WA 98405Study Coordinator · Study contact · 253-428-8700More trials in Tacoma
WI
- SSM Health Dean Medical Group ( Site 0087) · Madison, WI 53715Study Coordinator · Study contact · 516-488-2918More trials in Madison