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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1,530
Pembrolizumab 400 mg intravenous (IV) infusion q6w
Sacituzumab tirumotecan 4 mg/kg IV infusion q2w
Capecitabine 1000 mg/m\^2 to 1250 mg/m\^2 by mouth BID
Infirmary Cancer Care ( Site 0001)
Mobile, Alabama, United States
RECRUITINGIronwood Cancer & Research Centers-Research ( Site 0054)
Chandler, Arizona, United States
RECRUITINGMemorialCare Orange Coast Medical Center ( Site 9501)
Fountain Valley, California, United States
RECRUITINGScripps Cancer Center ( Site 0052)
La Jolla, California, United States
Invasive Disease-Free Survival (iDFS)
iDFS is the time from randomization to invasive local, regional, or distant recurrence, invasive contralateral breast cancer, or death due to any cause, whichever occurs first.
Time frame: Up to ~77 months
Overall Survival (OS)
OS is the time from randomization to death due to any cause.
Time frame: Up to ~101 months
Distant recurrence-free survival (DRFS)
DRFS is the time from randomization to distant recurrence or death due to any cause, whichever occurs first.
Time frame: Up to ~101 months
Change from baseline in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status (Item 29) and Quality of Life (Item 30) Combined Score
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life in cancer patients. The overall functioning score is based on participant responses that are scored on a 7-point scale (1 = "Very poor" to 7 = "Excellent"). Higher scores indicate better overall health status.
Time frame: Baseline and up to ~60 months
Change from baseline in EORTC QLQ-C30 Physical Functioning (Items 1-5) Combined Score
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The physical functioning score is based on participant responses to questions that scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better physical functioning.
Time frame: Baseline and up to ~60 months
Change from baseline in EORTC QLQ-C30 Role Functioning (Items 6 and 7) Combined Score
EORTC QLQ-C30 is a 30-item scale to assess the overall quality of life of cancer patients. The role functioning score is based on participant responses to questions that scored on a 4-point scale (1 = 'Not at All' to 4 = 'Very Much'). Higher scores indicate better role functioning.
Time frame: Baseline and up to ~60 months
Change from baseline in EORTC QLQ-C30 Fatigue (Items 10, 12, and 18) Combined Score
EORTC QLQ-C30 is a 30-item scale 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"). Lower scores indicate a better level of fatigue.
Time frame: Baseline and up to ~60 months
Number of participants who experience one or more adverse events (AEs)
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.
Time frame: Up to ~42 weeks
Number of participants who discontinue study intervention due to an AE
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.
Time frame: Up to 24 weeks
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Cancer and Blood Specialty Clinic ( Site 0008)
Los Alamitos, California, United States
COMPLETEDKaiser Permanente - Oakland ( Site 0079)
Oakland, California, United States
RECRUITINGProfound Research LLC ( Site 0105)
Oceanside, California, United States
RECRUITINGKaiser Permanente - Roseville ( Site 0081)
Roseville, California, United States
RECRUITINGKaiser Permanente - San Francisco ( Site 0080)
San Francisco, California, United States
RECRUITINGKaiser Permanente - Santa Clara ( Site 0082)
Santa Clara, California, United States
RECRUITING...and 266 more locations