A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
Breast Cancer
Unknown Primary
18 Years and older, Male and Female
2870-032 (primary)
NCI-2025-07234
2024-520190-12-00
jRCT2031250231
U1111-1316-7898
Summary
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
Eligibility
- 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 physician 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 Cycle1 Day 1 (C1D1). - 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 C1D1. - 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, has current pneumonitis/interstitial lung disease or has suspected interstitial lung disease (ILD) or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening..
Treatment Sites in Georgia
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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