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
Sponsors and collaborators
Merck Sharp & Dohme LLC
Lead sponsor
Daiichi Sankyo
Collaborator