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Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)

NCT06797635 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 372

Last updated 2026-05-20

No results posted yet for this study

Summary

Researchers are looking for new ways to treat triple-negative breast cancer (TNBC) and hormone receptor (HR) low positive/human epidermal growth factor receptor-2 (HER2) negative breast cancer. The main goals of this study are to learn:

* About the safety of the study treatments and if people tolerate them
* If people who receive patritumab deruxtecan, pembrolizumab, and chemotherapy before surgery have fewer cancer cells removed during surgery compared to those who receive only pembrolizumab (pembro) and chemotherapy.

Conditions

Interventions

BIOLOGICAL

Patritumab deruxtecan

Administered via IV infusion as neoadjuvant treatment

BIOLOGICAL

Pembrolizumab

Administered via IV infusion as neoadjuvant treatment in Part 1 and via IV infusion as neoadjuvant and adjuvant treatment in Part 2

DRUG

Paclitaxel

Administered via IV infusion as neoadjuvant treatment

DRUG

Carboplatin

Administered via IV infusion as neoadjuvant treatment

DRUG

Doxorubicin hydrochloride

Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2

DRUG

Epirubicin hydrochloride

Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2

DRUG

Cyclophosphamide

Administered via IV infusion as neoadjuvant treatment in Arm C and an option for adjuvant treatment for participants with residual disease in Arms A and B in Part 2

DRUG

Capecitabine

Administered via oral tablets as an option for adjuvant treatment for participants with residual disease in Part 2

DRUG

Olaparib

Administered via oral tablets as an option for adjuvant treatment for participants with germline BRCA mutations and residual disease in Part 2

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-20
Primary Completion
2029-12-31
Completion
2034-12-31
FDA Drug
Yes

Countries

  • United States
  • South Korea
  • Spain
  • Taiwan

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06797635 on ClinicalTrials.gov