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Breast NeoplasmsCancerWomen's healthBiologicalDrugPhase 2

What this study is

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.

What's being tested

  • Patritumab deruxtecan

    Intervention · BIOLOGICAL

  • Pembrolizumab

    Intervention · BIOLOGICAL

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

  • Paclitaxel

    Intervention · DRUG

  • Carboplatin

    Intervention · DRUG

  • Doxorubicin hydrochloride

    Intervention · DRUG

  • Epirubicin hydrochloride

    Intervention · DRUG

  • Cyclophosphamide

    Intervention · DRUG

  • Capecitabine

    Intervention · DRUG

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

  • Olaparib

    Intervention · DRUG

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

All of Patritumab deruxtecan, Paclitaxel, Carboplatin

Administered via IV infusion as neoadjuvant treatment

All of Doxorubicin hydrochloride, Epirubicin hydrochloride, 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

Study details

Official title
An Open-label Randomized Phase 2 Study to Evaluate Safety and Efficacy of Patritumab Deruxtecan Plus Pembrolizumab Administered Either Before or After Carboplatin/Paclitaxel Plus Pembrolizumab Compared With Pembrolizumab in Combination With Chemotherapy Followed by Surgery and Adjuvant Pembrolizumab for High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/Human Epidermal Growth Factor Receptor-2 Negative Breast Cancer (HERTHENA-Breast03)
Sponsor
Merck Sharp & Dohme LLC
Conditions
Breast Neoplasms · Breast Cancer
Enrolling
372 people
Starts
2025-03-20
Est. completion
2031-03-16
Design
Open-label, randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗