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New treatment option for Breast Neoplasms
Official title A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
ClinicalTrials.gov ID: NCT06966700
What this study is testing
What is Sacituzumab tirumotecan?
Sacituzumab tirumotecan is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for breast neoplasms.
Also referred to as Sac-TMT, MK-2870.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- The main 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)...
- cT1c, N1-N2
- cT2, N0-N2
- cT3, N0-N2
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- The main 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...
- 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...
- 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.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Burbank, California, United States
- Clovis, California, United States
- Fullerton, California, United States
- Long Beach, California, United States
- Mountain View, California, United States
- Newport Beach, California, United States
- Whittier, California, United States
- Denver, Colorado, United States
- Grand Junction, Colorado, United States
- Altamonte Springs, Florida, United States
- Fort Myers, Florida, United States
- Hialeah, Florida, United States
- Jacksonville, Florida, United States
- St. Petersburg, Florida, United States
- Newnan, Georgia, United States
- Fort Wayne, Indiana, United States
- Indianapolis, Indiana, United States
+ 257 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Burbank, California, United States; Clovis, California, United States; Fullerton, California, United States and 271 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.