A clinical study of sac-TMT in people with breast cancer (MK-2870-032)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Merck Sharp & Dohme LLC

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

10 Nov 2025 → ongoing

Decision date (initial)

2025-08-28

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Merck Sharp & Dohme LLC

External identifiers

EU CT number

2024-520190-12-00

WHO UTN

U1111-1316-7898

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Therapy, Safety, Pharmacogenetic, Pharmacoeconomic, Diagnosis, Pharmacogenomic, Pharmacokinetic

1. To compare sac-TMT followed by carboplatin/paclitaxel versus chemotherapy, both in combination with pembrolizumab as neoadjuvant therapy with respect to rate of pCR (ypT0/Tis ypN0) at the time of surgery, as assessed by local pathologist in all participants.

2. To compare sac-TMT followed by carboplatin/paclitaxel versus chemotherapy, both in combination with pembrolizumab as neoadjuvant therapy and pembrolizumab with optional adjuvant TPC with respect to EFS as assessed by investigator in all participants.

Secondary objectives 8

1. To compare sac-TMT followed by carboplatin/paclitaxel versus chemotherapy, both in combination with pembrolizumab as neoadjuvant therapy and pembrolizumab with optional adjuvant TPC with respect to OS in all participants.
2. To compare sac-TMT followed by carboplatin/paclitaxel versus chemotherapy, both in combination with pembrolizumab as neoadjuvant therapy with respect to rate of pCR-no DCIS (ypT0 ypN0) at the time of surgery, as assessed by local pathologist in all participants.
3. To compare sac-TMT followed by carboplatin/paclitaxel versus chemotherapy, both in combination with pembrolizumab as neoadjuvant therapy with respect to rate of pCR (ypT0/Tis ypN0) at the time of surgery, as assessed by local pathologist in all participants with high-risk, early-stage, TNBC.
4. To compare sac-TMT followed by carboplatin/paclitaxel versus chemotherapy, both in combination with pembrolizumab as neoadjuvant therapy and pembrolizumab with optional adjuvant TPC with respect to EFS as assessed by investigator in all participants with high-risk, early-stage, TNBC.
5. To compare sac-TMT followed by carboplatin/paclitaxel versus chemotherapy, both in combination with pembrolizumab as neoadjuvant therapy and pembrolizumab with optional adjuvant TPC with respect to OS in participants with high-risk, early-stage, TNBC.
6. To compare sac-TMT followed by carboplatin/paclitaxel versus chemotherapy, both in combination with pembrolizumab as neoadjuvant therapy and pembrolizumab with optional adjuvant TPC with respect to DPDRFS in all participants.
7. To evaluate mean change from baseline in HRQoL assessments using EORTC QLQ-C30 and EORTC QLQ-BR42 questionnaires in both arms.
8. To evaluate the safety and tolerability of sac-TMT plus pembrolizumab followed by carboplatin/paclitaxel plus pembrolizumab.

Conditions and MedDRA coding

Breast Cancer: triple negative breast cancer (TNBC) and hormone receptor (HR)-low positive/HER2 negative breast cancer

Regulatory references

Scientific advice from competent authorities

Food And Drug Administration

Plan to share IPD

Yes

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Has previously untreated high-risk, early-stage, non-metastatic (M0) breast cancer (BC), defined as tumor stage T1c, nodal stage N1-2, or tumor stage T2-4, nodal stage N0-2
2. Has centrally confirmed diagnosis of BC that is triple-negative or hormone receptor (HR)-low positive/ human epidermal growth factor receptor-2 (HER2) negative, based on the American Society of Clinical Oncology/College of American Pathologists guidelines
3. Has Eastern Cooperative Oncology Group performance status of 0 or 1 performed within 28 days before treatment randomization
4. Has left ventricle ejection fraction of ≥50% or ≥ institution lower limit of normal as assessed by echocardiogram or multigated acquisition scan performed at screening
5. Has a history of exposure to anthracycline; participants can be eligible after completion of a Sponsor consultation form, if cumulative lifetime doses are as follows: Doxorubicin <100 mg/m2, Epirubicin <180 mg/m2, Mitoxantrone <40 mg/m2, Idarubicin <22.5 mg/m2. Note: If another anthracycline or more than one anthracycline has been used, the cumulative dose must not exceed the equivalent of 100 mg/m2 of doxorubicin.

Exclusion criteria 16

1. Has Grade ≥2 peripheral neuropathy
2. Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing
3. Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn’s disease, ulcerative colitis, or chronic diarrhea)
4. Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
5. Has uncontrolled systemic disease (eg, uncontrolled hypertension or diabetes, or clinically symptomatic pleural effusion, pericardial effusion, or ascites)
6. Has human immunodeficiency virus and a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease
7. Received any prior treatment, including radiation, systemic therapy, and/or definitive surgery for currently diagnosed BC
8. Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
9. Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed
10. Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention
11. Known additional malignancy that is progressing or has required active treatment within the past 5 years
12. Active autoimmune disease that has required systemic treatment in the past 2 years
13. History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
14. Concurrent active Hepatitis B or Hepatitis C virus infection
15. History of stem cell/solid organ transplant
16. Has not adequately recovered from major surgery or has ongoing surgical complications

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Pathological Complete Response (pCR) Rate Using the Definition of ypT0/Tis ypN0
2. Event-Free Survival (EFS)

Secondary endpoints 13

1. Overall Survival (OS)
2. pCR-No Ductal Carcinoma in Situ (DCIS) Rate Using the Definition of ypT0 ypN0
3. pCR (ypT0/Tis ypN0) in Participants with High-Risk, Early-Stage, Triple Negative Breast Cancer (TNBC)
4. EFS in Participants with High-Risk, Early-Stage, TNBC
5. OS in Participants with High-Risk, Early-Stage, TNBC
6. Distant Progression or Distant Recurrence-Free Survival (DPDRFS)
7. Change from Baseline in the European Organisation for Research and Treatment of Cancer (EORTC)- Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status/Quality of Life (GHS/QoL) Score
8. Change from Baseline in EORTC-QLQ-C30 Physical Functioning Score
9. Change from Baseline in EORTC QLQ-C30 Role Functioning Score
10. Change from Baseline in EORTC QLQ-C30 Fatigue Score
11. Change from Baseline in EORTC QLQ-Breast Cancer Questionnaire (BR42) Systemic Therapy Side Effects
12. Number of Participants with One or More Adverse Events (AEs)
13. Number of Participants Who Discontinue Study Intervention Due to an AE

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Comparator 3

Auxiliary 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Merck Sharp & Dohme LLC

Sponsor organisation

Merck Sharp & Dohme LLC

Address

126 East Lincoln Avenue, P. O. Box 2000 P. O. Box 2000

City

Rahway

Postcode

07065-4607

Country

United States

Scientific contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Francisco Beca

Public contact point

Organisation

Merck Sharp & Dohme LLC

Contact name

Francisco Beca

Third parties 12

Locations

14 EU/EEA countries · 92 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 130 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

14 submissions — initial application plus substantial / non-substantial modifications