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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

No Placebo-Only Group

Pivotal Trial

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to ~101 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Invasive Disease-Free Survival (iDFS)

Secondary study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 3

~2810

0 / 12Eligibility criteria met