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sac-TMT + Pembrolizumab for Breast Cancer

Phase 3
Recruiting
Research Sponsored by Merck Sharp & Dohme LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Had neoadjuvant treatment based on the KEYNOTE-522 regimen followed by surgery according to National Comprehensive Cancer Network (NCCN) treatment guidelines for TNBC
Has non-pathologic complete response at surgery
Must not have
Has Grade >2 peripheral neuropathy
Received prior radiotherapy within 3 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to ~101 months
Awards & highlights

Summary

"This trial is comparing the effectiveness and safety of sacituzumab tirumotecan (sac-TMT) combined with pembrolizumab to standard treatment in patients with triple-negative breast

Who is the study for?
This trial is for individuals with triple-negative breast cancer (TNBC) who didn't fully respond to neoadjuvant therapy and surgery. Participants must have completed any required radiation, be able to continue on pembrolizumab, and not show signs of cancer relapse. Strict contraception or abstinence is required for both male and female participants during the trial and for a period after.
What is being tested?
The study compares sacituzumab tirumotecan (sac-TMT) combined with pembrolizumab against the physician's choice of treatment in TNBC patients post-surgery without a pathological complete response. The main goal is to see if sac-TMT plus pembrolizumab improves disease-free survival compared to other treatments.
What are the potential side effects?
Potential side effects include those common to chemotherapy such as nausea, fatigue, hair loss, increased risk of infection due to lowered immunity, as well as specific reactions related to sac-TMT or pembrolizumab like infusion reactions or autoimmune-like symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I followed the KEYNOTE-522 treatment before surgery for triple-negative breast cancer.
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My surgery did not remove all of my cancer.
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I can continue taking pembrolizumab as a follow-up treatment.
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My breast cancer is triple-negative, confirmed by specific guidelines.
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My cancer has not returned or spread, as confirmed by my doctor.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have severe nerve damage in my hands or feet.
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I had radiation therapy less than 3 weeks ago or need steroids for radiation side effects.
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I have a severe eye condition that affects my cornea or eyelid glands.
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I have a BRCA gene mutation and can receive olaparib as follow-up treatment.
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I have active inflammatory bowel disease or a history of it.
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I do not have serious heart or brain blood vessel problems.
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I am taking medication that strongly affects liver enzymes and can't stop during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to ~101 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to ~101 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Invasive Disease-Free Survival (iDFS)
Secondary outcome measures
Change from baseline in EORTC QLQC30 Fatigue Score
Change from baseline in EORTC QLQC30 Physical Functioning Score
Change from baseline in EORTC QLQC30 Role Functioning Score
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pembrolizumab + sac-TMTExperimental Treatment2 Interventions
Participants receive pembrolizumab every 6 weeks (q6w) in combination with sac-TMT every 2 weeks (q2w) for 24 weeks. In addition, participants receive an antihistamine, an H2 antagonist of investigator's choice, acetaminophen (or equivalent), and dexamethasone (or equivalent) per each drug's product label prior to sac-TMT infusions.
Group II: Treatment of Physician's ChoiceActive Control2 Interventions
Participants receive pembrolizumab q6w or pembrolizumab q6w in combination with capecitabine (twice daily \[BID\] on Days 1 to 14 and 22 to 35 every 42 days x 4 \[2 weeks 1, 1 week off\]) for 24 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2070

Find a Location

Who is running the clinical trial?

Merck Sharp & Dohme LLCLead Sponsor
3,950 Previous Clinical Trials
5,173,576 Total Patients Enrolled
59 Trials studying Breast Cancer
7,408 Patients Enrolled for Breast Cancer
Medical DirectorStudy DirectorMerck Sharp & Dohme LLC
2,834 Previous Clinical Trials
8,078,250 Total Patients Enrolled
8 Trials studying Breast Cancer
5,963 Patients Enrolled for Breast Cancer
~1020 spots leftby Dec 2030
Unbiased ResultsWe believe in providing patients with all the options.
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