A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
Purpose
Researchers are looking for new ways to treat types of breast cancer that are both: - High-risk, which means the cancer may have a higher chance of getting worse or coming back after treatment - Early-stage, which means the cancer is in the breast or the lymph nodes around the breast The 2 types of breast cancer in this study are triple-negative breast cancer (TNBC) and hormone receptor (HR)-low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. These cancers have zero or a low amount of a protein called HER2 and other proteins that attach to the hormones estrogen or progesterone. Sacituzumab tirumotecan (also known as sac-TMT or MK-2870), the study medicine, is a type of targeted therapy. A targeted therapy is a treatment that works to control how specific types of cancer cells grow and spread. The main goals of this study are to learn if people who receive sac-TMT, pembrolizumab, and chemotherapy: - Have fewer cancer cells found in the tumors and lymph nodes removed during surgery compared to those who receive only pembrolizumab and chemotherapy - Live longer without the cancer growing, spreading, or coming back compared to people who receive only pembrolizumab with chemotherapy
Conditions
- Breast Neoplasms
- Triple Negative Breast Neoplasms
- HR Low-Positive/HER2-Negative Breast Neoplasms
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
The main inclusion criteria include but are not limited to the following: - Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per AJCC 8th edition criteria as assessed by the investigator based on radiological and/or clinical assessment: - cT1c, N1-N2 - cT2, N0-N2 - cT3, N0-N2 - cT4a-d, N0-N2 - The participant must have a centrally confirmed diagnosis of BC that is triple-negative or HR-low+/HER2- (defined as estrogen receptor (ER)-low+ expression in 1% to 10% cells and HER2-), as by the most recent American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines. - Provides a core needle biopsy from the primary breast tumor at screening to the central laboratory. - Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 28 days before treatment randomization. - Demonstrates adequate organ function.
Exclusion Criteria
The main exclusion criteria include but are not limited to the following: - Metastatic (Stage IV) breast cancer or clinical node stage 3 (cN3) nodal involvement - Has received any prior treatment, including radiation, systemic therapy,and/or definitive surgery for currently diagnosed breast cancer - Has undergone excisional biopsy of the primary tumor, axillary lymph node dissection, and/or axillary sentinel lymph node biopsy prior to study treatment. - Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization. - Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, CTLA-4, OX- 40, CD137). - Received prior treatment with a TROP2-targeted antibody-drug conjugate (ADC). - Received prior treatment with a topoisomerase I inhibitor-containing ADC. - Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. - Known additional malignancy that is progressing or has required active treatment within the past 5 years. - Uncontrolled systemic disease. - History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental sac-TMT |
Participants receive sacituzumab tirumotecan intravenously (IV) at a dose of 4 mg/kg every 2 weeks (Q2W) + IV pembrolizumab 200 mg every 3 weeks (Q3W), for 12 weeks; then receive IV pembrolizumab 200 mg Q3W and IV carboplatin area under the curve (AUC) 1.5 + IV paclitaxel 80 mg/m^2 once weekly, for 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant treatment of physician's choice (TPC) may be administered to participants with residual disease. TPC options are olaparib 300 mg oral twice daily (BID) for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); capecitabine 1000-1250 mg/m^2 oral twice daily on days 1-14 and 22-35 each cycle for 4 six-week cycles; or doxorubicin 60mg/m^2 (or epirubicin 90 mg/m^2) IV infusion Q3W/Q2W + cyclophosphamide 600 mg/m^2 IV infusion Q3W/Q2W for 4 doses. |
|
|
Active Comparator Chemotherapy |
Participants receive IV carboplatin AUC 1.5 and paclitaxel 80 mg/m^2 once weekly, alongside pembrolizumab 200 mg Q3W, for 6 weeks; then receive IV pembrolizumab 200 mg Q3W alongside IV cyclophosphamide 600 mg/m^2 Q3W and either doxorubicin 60 mg/m^2 Q3W or epirubicin 90 mg/m^2 Q3W, for up to 12 weeks. 3-6 weeks later, participants undergo surgery and optional radiation therapy, and receive IV pembrolizumab 400 mg once every 6 weeks or 200 mg Q3W for up to approximately 28 weeks. Additional adjuvant TPC may be administered to participants with residual disease. TPC options are olaparib 300 mg oral BID for 1 year (participants with germline breast cancer susceptibility gene mutation (gBRCAm) only); or capecitabine 1000-1250 mg/m^2 oral BID on days 1-14 and 22-35 each cycle for 4 six-week cycles. |
|
Recruiting Locations
Gilbert, Arizona 85234
Study Coordinator
480-256-6444
Phoenix, Arizona 85054
Study Coordinator
480-574-2802
Tucson, Arizona 85719
Study Coordinator
520-694-2873
Burbank, California 91505
Study Coordinator
818-840-0921
Fullerton, California 92835
Study Coordinator
714-446-5900
Newport Beach, California 92663
Study Coordinator
949-764-4624
Whittier, California 90602
Study Coordinator
562-698-6888
Denver, Colorado 80218
Study Coordinator
303-318-3434
Grand Junction, Colorado 81501
Study Coordinator
970-298-7638
Altamonte Springs, Florida 32701
Study Coordinator
407-834-5151
Fort Myers, Florida 33901
Study Coordinator
239-274-9930
Hialeah, Florida 33013
Study Coordinator
833-489-4968
Jacksonville, Florida 32224
Study Coordinator
904-953-7290
St. Petersburg, Florida 33701
Study Coordinator
727-216-1143
Fort Wayne, Indiana 46804
Study Coordinator
260-436-0800
Indianapolis, Indiana 46237
Study Coordinator
317-528-7060
New Orleans, Louisiana 70121
Study Coordinator
866-624-7637
Shreveport, Louisiana 71103
Study Coordinator
318-626-0000
Westbrook, Maine 04092
Study Coordinator
207-303-3300
Baltimore, Maryland 21202
Study Coordinator
410-951-7956
Kansas City, Missouri 64111
Study Coordinator
816-923-2677
St Louis, Missouri 63110
Study Coordinator
314-286-2341
Lincoln, Nebraska 68516
Study Coordinator
402-327-7363
Las Vegas, Nevada 89102
Study Coordinator
702-724-8787
Reno, Nevada 89502
Study Coordinator
775-982-4000
Hackensack, New Jersey 07601
Study Coordinator
551-996-5855
New Brunswick, New Jersey 08901
Study Coordinator
732-253-3939
Grand Forks, North Dakota 58201
Study Coordinator
701-780-5451
Cincinnati, Ohio 45220
Study Coordinator
513-853-1300
Charleston, South Carolina 29425
Study Coordinator
843-792-6434
Sioux Falls, South Dakota 57105
Study Coordinator
605-322-3000
Yankton, South Dakota 57078
Study Coordinator
605-601-1830
Knoxville, Tennessee 37909
Study Coordinator
865-934-5800
Nashville, Tennessee 37208
Study Coordinator
615-341-4383
Nashville, Tennessee 37232
Study Coordinator
615-322-2064
Abilene, Texas 79601
Study Coordinator
325-670-2000
Fort Worth, Texas 76104
Study Coordinator
817-702-8049
Houston, Texas 77025
Study Coordinator
713-239-4510
Houston, Texas 77025
Study Coordinator
713-239-4510
Houston, Texas 77030
Study Coordinator
713-275-3233
San Antonio, Texas 78240
Study Coordinator
210-595-5300
Murray, Utah 84107
Study Coordinator
801-507-3630
Midlothian, Virginia 23114
Study Coordinator
804-893-8717
Roanoke, Virginia 24014
Study Coordinator
540-982-0237
Seattle, Washington 98109
Study Coordinator
855-557-0555
Spokane, Washington 99202
Study Coordinator
509-228-1000
Tacoma, Washington 98405
Study Coordinator
253-428-8700
Madison, Wisconsin 53792
Study Coordinator
608-263-0796
More Details
- Status
- Recruiting
- Sponsor
- Merck Sharp & Dohme LLC