T-DXd Based Therapy for HER2 Positive Breast Cancer
(DB-Guide Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will evaluate a structured sequential treatment strategy starting with T-DXd + pertuzumab upfront therapy, followed by an optimized maintenance therapy with dual HER2+blockade + CDK4/6i + ET and the opportunity to retreat with T-DXd once patients progress under maintenance aimed to maximizing disease control, optimizing tolerability, and preserving T-DXd as a future therapeutic option, while ensuring participant safety and regulatory compliance in participants with HER2+/HR+ advanced/metastatic breast cancer.
Are You a Good Fit for This Trial?
This trial is for adults (18+) with advanced or metastatic breast cancer that is both HER2-positive and hormone receptor positive. Participants must not have had prior chemotherapy or HER2-targeted therapy for their metastatic disease, but can have received certain treatments earlier if enough time has passed since completion.Inclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- Endocrine Therapy
- Palbociclib
- Pertuzumab
- Trastuzumab
- Trastuzumab deruxtecan (T-DXd)
Trial Overview
The study tests a stepwise treatment: starting with T-DXd plus pertuzumab, then switching to maintenance therapy using dual HER2 blockade (pertuzumab + trastuzumab), endocrine therapy, and palbociclib. If the cancer progresses, patients may be retreated with T-DXd.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Adult participants with previously untreated advanced or metastatic HER2+/HR+ breast cancer who will receive T-DXd intravenously every 3 weeks (IV Q3W) in 3 treatment phases: Upfront treatment phase: T-DXd + pertuzumab IV Q3W Maintenance treatment phase: Trastuzumab + palbociclib + endocrine therapy + pertuzumab IV Q3W T-DXD retreatment phase: T-DXd monotherapy IV Q3W
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
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
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