A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)

NCT06966700
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Phase
Phase 3
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Recruitment status
Recruiting
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Participants
2,400
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Lead sponsor
Merck Sharp & Dohme LLC
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Start date
2025-06-30
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Number of sites
321
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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
clinicaltrials.gov
Short title
A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
clinicaltrials.gov
Official title
A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Sac-TMT (Sacituzumab Tirumotecan, MK-2870) Followed by Carboplatin/Paclitaxel vs Chemotherapy, Both in Combination With Pembrolizumab as Neoadjuvant Therapy for High-Risk, Early-Stage, Triple-Negative Breast Cancer or Hormone Receptor-low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2034-12-29
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First posted
2025-05-13
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Registry last updated
2026-08-28
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Primary completion date
2033-03-23
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Start date
2025-06-30
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Participants
2,400
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Participant count basis
Estimated
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Planned participants
2,400
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Protocol amendments
2
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Number of sites
321
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Merck Sharp & Dohme LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06966700
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ClinicalTrials.gov ID
NCT06966700
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Percentage of Participants with Pathological Complete Response (pCR) at the Time of Definitive Surgery

    Timeframe: Up to approximately 30 weeks

    pCR (ypT0/Tis ypN0) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy per current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.

  2. Event-Free Survival (EFS)

    Timeframe: Up to approximately 92 months

    EFS is defined as the time from randomization to disease progression that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first.

  1. Overall Survival (OS)

    Timeframe: Up to approximately 115 months

    OS is defined as the time from randomization to death due to any cause.

  2. Percentage of Participants with pCR with No Ductal Carcinoma in Situ (pCR-no DCIS) at the Time of Definitive Surgery

    Timeframe: Up to approximately 30 weeks

    pCR-no ductal carcinoma in situ (DCIS) (ypT0 ypN0) is defined as the absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy per current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery.

  3. Percentage of Participants with pCR at the Time of Definitive Surgery (High-risk, early-stage, TNBC subset)

    Timeframe: Up to approximately 30 weeks

    pCR (ypT0/Tis ypN0) is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes after completion of neoadjuvant systemic therapy per current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery. The pCR will be presented for the subset of participants who enrolled with high-risk, early-stage, TNBC.

  4. Event-Free Survival (EFS) (High-risk, early-stage, TNBC subset)

    Timeframe: Up to approximately 92 months

    EFS is defined as the time from randomization to disease progression that precludes surgery, local or distant recurrence, or death due to any cause, whichever occurs first. The EFS will be presented for the subset of participants who enrolled with high-risk, early-stage, TNBC.

  5. Overall Survival (OS) (High-risk, early-stage, TNBC subset)

    Timeframe: Up to approximately 115 months

    OS is defined as the time from randomization to death due to any cause.

  6. Distant Progression or Distant Recurrence-Free Survival (DPDRFS)

    Timeframe: Up to approximately 92 months

    DPDRFS is defined as the time from randomization to first distant progression or distant recurrence event as assessed by investigator, or death due to any cause, whichever occurs first.

  7. Change from Baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Global Health Status-Quality of Life Score

    Timeframe: Baseline and up to approximately 3 years

    The EORTC-QLQ-C30 is a 30-item questionnaire developed to assess the QoL of cancer patients. Participant responses to Item 30 (""How would you rate your overall quality of life during the past week?") is scored on a 7-point scale (1=Very Poor to 7=Excellent). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher value indicates a better level of function. The change from baseline in EORTC QLQ-C30 Item 30 score will be reported.

  8. Change from Baseline in EORTC QLQ-C30 Physical Functioning Score

    Timeframe: Baseline and up to approximately 3 years

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their physical functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of physical functioning.

  9. Change from Baseline in EORTC QLQ-C30 Role Functioning Score

    Timeframe: Baseline and up to approximately 3 years

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their role functioning are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A higher score indicates a better level of physical functioning.

  10. Change from Baseline in EORTC QLQ-C30 Fatigue Score

    Timeframe: Baseline and up to approximately 3 years

    The EORTC QLQ-C30 is a 30-item questionnaire to assess the overall quality of life of cancer patients. Participant responses to questions about their fatigue are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a better level of function.

  11. Change from Baseline in EORTC QLQ Breast Cancer 42 (BR42) Systemic Therapy Side Effects Score

    Timeframe: Baseline and up to approximately 3 years

    The EORTC QLQ-BR42 is a 42-item questionnaire to assess the overall quality of life of breast cancer patients. Participant responses to questions about their systemic therapy side effects are scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores are standardized, so that scores range from 0 to 100. A lower score indicates a lower level of side effects.

  12. Number of Participants Who Experience One or More Adverse Events (AEs)

    Timeframe: Up to approximately 67 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

  13. Number of Participants Who Discontinue Study Treatment Due to an AE

    Timeframe: Up to approximately 54 weeks

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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.

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..
Sources for eligibility
clinicaltrials.gov

  • Banner MD Anderson Cancer Center ( Site 0066)Gilbert, United StatesRecruiting
  • Mayo Clinic Cancer Center ( Site 0034)Phoenix, United StatesRecruiting
  • University of Arizona Cancer Center ( Site 0035)Tucson, United StatesRecruiting
  • Roy and Patricia Disney Family Cancer Center ( Site 0055)Burbank, United StatesRecruiting
  • Community Cancer Institute ( Site 0100)Clovis, United StatesRecruiting
  • Providence Medical Foundation ( Site 0080)Fullerton, United StatesRecruiting
  • MemorialCare Health System - Long Beach Medical Center ( Site 9556)Long Beach, United StatesRecruiting
  • El Camino Hospital Cancer Center ( Site 0096)Mountain View, United StatesRecruiting
  • Hoag Memorial Hospital Presbyterian ( Site 0010)Newport Beach, United StatesRecruiting
  • Helios Clinical Research ( Site 0061)Whittier, United StatesRecruiting
  • Intermountain Health Cancer Center Saint Joseph ( Site 0062)Denver, United StatesRecruiting
  • Rocky Mountain Cancer Centers (RMCC) ( Site 8006)Denver, United StatesRecruiting
  • Intermountain Health St. Mary's Regional Hospital ( Site 0054)Grand Junction, United StatesRecruiting
  • AdventHealth Medical Group Oncology and Hematology at Altamonte ( Site 0044)Altamonte Springs, United StatesRecruiting
  • Florida Cancer Specialists - South ( Site 7004)Fort Myers, United StatesRecruiting
  • Bioresearch Partner ( Site 0072)Hialeah, United StatesRecruiting
  • Mayo Clinic Hospital ( Site 0013)Jacksonville, United StatesRecruiting
  • Florida Cancer Specialists - North ( Site 7002)St. Petersburg, United StatesRecruiting
  • City of Hope Cancer Center - Atlanta ( Site 0102)Newnan, United StatesRecruiting
  • Fort Wayne Medical Oncology and Hematology ( Site 0084)Fort Wayne, United StatesRecruiting
  • Franciscan Health ( Site 0077)Indianapolis, United StatesRecruiting
  • Ochsner Clinic Foundation ( Site 0021)New Orleans, United StatesRecruiting
  • Louisiana State University Health Sciences Shreveport ( Site 0053)Shreveport, United StatesRecruiting
  • New England Cancer Specialists ( Site 0051)Westbrook, United StatesRecruiting
  • Mercy Medical Center - Baltimore ( Site 0015)Baltimore, United StatesRecruiting

And 296 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • U1111-1316-7898
  • 2024-520190-12-00
  • jRCT2031250231
Sources for references
clinicaltrials.gov

Related records

Drugs (10)

Lead sponsors (1)

Conditions (2)

Targets (22)