Trastuzumab Deruxtecan for Breast Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires a washout period (time without taking certain medications) before starting the study drug. This means you may need to stop taking some of your current medications for a certain period before joining the trial. It's best to discuss your specific medications with the study team to understand what changes might be needed.
What data supports the effectiveness of the drug Trastuzumab Deruxtecan for breast cancer?
Trastuzumab Deruxtecan has shown effectiveness in treating HER2-positive breast cancer, especially in patients who have already tried other treatments. In studies, it helped patients live longer without the cancer getting worse compared to previous treatments, and it was generally safe to use with manageable side effects.12345
Is Trastuzumab Deruxtecan safe for humans?
How is the drug Trastuzumab Deruxtecan unique for treating HER2-positive breast cancer?
Trastuzumab Deruxtecan is unique because it is an antibody-drug conjugate that combines a targeted anti-HER2 antibody with a powerful chemotherapy agent, allowing it to deliver the drug directly to cancer cells. This approach can be more effective and have a longer response duration compared to previous treatments like trastuzumab emtansine, especially in patients who have already received other anti-HER2 therapies.12359
What is the purpose of this trial?
The purpose of this study is to test the good and bad effects of a drug called trastuzumab deruxtecan (T-DXd) in adult patients with metastatic HER2-negative breast cancer and which patients might benefit the most from T-DXd.
Research Team
Maryam Lustberg, M.D.
Principal Investigator
Yale University
Eligibility Criteria
Adults with metastatic HER2-negative breast cancer, either hormone receptor-positive or negative, who have had 1-2 prior systemic treatments but no anti-HER2 therapy. Participants must have measurable disease and good heart, bone marrow, kidney, liver, and blood clotting function. They should not be pregnant or breastfeeding and must use contraception.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Trastuzumab Deruxtecan intravenously every 3 weeks at a dose of 5.4 mg/kg until disease progression, limiting toxicity, withdrawal of consent, or death
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Overall survival and progression-free survival are monitored every 3 months
Treatment Details
Interventions
- Trastuzumab Deruxtecan
Find a Clinic Near You
Who Is Running the Clinical Trial?
Yale University
Lead Sponsor
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
Daiichi Sankyo
Industry 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