Patritumab + Trastuzumab for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
The primary purpose of the study is to assess the safety, tolerability, and anti-tumor activity of HER3-DXd and T-DXd in the combination dosing regimens in participants with hormone receptor positive, HER2-low or HER2-ultralow, unresectable, or metastatic breast cancer.
Are You a Good Fit for This Trial?
This trial is for adults with hormone receptor-positive, HER2-low or ultralow breast cancer that cannot be removed by surgery or has spread (metastatic). Participants must have tried and not benefited from endocrine therapy and a CDK4/6 inhibitor, and their cancer must have recently gotten worse.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Patritumab deruxtecan
- Trastuzumab deruxtecan
Trial Overview
The study is testing the safety and effectiveness of combining two drugs—Patritumab deruxtecan (HER3-DXd) and Trastuzumab deruxtecan (T-DXd)—in people with advanced HR-positive, HER2-low or ultralow breast cancer. The trial includes different dosing regimens.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Active Control
Participants with unresectable or mBC will receive T-DXd and HER3-DXd in a combination regimen based on the available Part 1 data until disease progression, death, unacceptable toxicity, or trial close.
Participants with unresectable or mBC will receive T-DXd and HER3-DXd in combination regimen B until disease progression, death, unacceptable toxicity, or trial close.
Participants with unresectable or metastatic breast cancer (mBC) will receive T-DXd and HER3-DXd in combination regimen A until disease progression, death, unacceptable toxicity, or trial close.
Participants with unresectable or mBC will receive T-DXd monotherapy until disease progression, death, unacceptable toxicity, or trial close.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Daiichi Sankyo
Lead Sponsor
Hiroyuki Okuzawa
Daiichi Sankyo
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Yuki Abe
Daiichi Sankyo
Chief Medical Officer since 2023
MD
Merck Sharp & Dohme LLC
Industry Sponsor
Chirfi Guindo
Merck Sharp & Dohme LLC
Chief Marketing Officer since 2022
Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business
Robert M. Davis
Merck Sharp & Dohme LLC
Chief Executive Officer since 2021
JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University
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