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)

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMerck Sharp & Dohme LLC

About this trial

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.

Eligibility criteria

Qualifiers

Has locally advanced, non-metastatic (M0), breast cancer, defined as any of the following combined primary tumor (T) and regional lymph node (N) staging per current American Joint Committee on Cancer (AJCC) criteria: cT1c, N1-N2; cT2, N0-N2; cT3, N0-N2; or cT4a-d, N0-N2

Has centrally confirmed diagnosis of breast cancer that is triple-negative or HR-low+/HER2- breast cancer that will be treated according to the triple-negative breast cancer (TNBC) paradigm

Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load

Participants with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable

Disqualifiers

Has uncontrolled or significant cardiovascular disease before randomization

Has any history of or evidence of any current leptomeningeal carcinomatosis.

Has clinically significant corneal disease

Has human immunodeficiency virus (HIV) infection with a history of Kaposi sarcoma and/or multicentric Castleman disease

Trial design

Treatments tested in this trial

  • Patritumab deruxtecan
  • Pembrolizumab
  • Paclitaxel
  • Carboplatin
  • Doxorubicin hydrochloride
  • Epirubicin hydrochloride
  • Cyclophosphamide
  • Capecitabine
  • Olaparib

Treatment groups

372 Participants
are divided into 4 treatment groups

Sponsors and collaborators

Merck Sharp & Dohme LLC

Lead sponsor

Daiichi Sankyo

Collaborator