Dato-DXd for Triple-negative Breast Cancer
Trial Summary
Do I need to stop my current medications to join the trial?
The trial requires a 'washout period' (time without taking certain medications) before starting the study. This includes stopping any anti-cancer therapy, including hormonal therapy, for at least 3 weeks, and other specific medications like chloroquine/hydroxychloroquine for more than 14 days. It's best to discuss your current medications with the trial team to see if they need to be stopped.
What data supports the effectiveness of the drug Dato-DXd for treating triple-negative breast cancer?
Research shows that the drug datopotamab deruxtecan (Dato-DXd) has shown encouraging response rates in patients with advanced triple-negative breast cancer, with 34% experiencing a complete or partial response. Additionally, eribulin, another component of the treatment, has been found to work well with other drugs to kill cancer cells in this type of breast cancer.12345
Is Dato-DXd safe for humans?
What makes the drug Dato-DXd unique for treating triple-negative breast cancer?
Dato-DXd is unique because it is an antibody-drug conjugate that targets TROP-2, a protein often found in triple-negative breast cancer, and delivers a topoisomerase I inhibitor directly to the cancer cells, potentially improving effectiveness and reducing side effects compared to traditional chemotherapy.23478
What is the purpose of this trial?
This trial is testing a new drug called Dato-DXd to see if it works better than current treatments for patients with a specific type of breast cancer that has come back or spread and cannot be treated with certain common therapies. The drug aims to target and kill cancer cells more effectively.
Eligibility Criteria
This trial is for adults with triple-negative breast cancer that's locally recurrent and inoperable or has spread (metastatic), who haven't had chemotherapy for this condition, and can't use PD-1/PD-L1 inhibitor therapy. Participants need at least one measurable tumor lesion, good physical status (ECOG PS 0 or 1), adequate organ function, a life expectancy of over 12 weeks, and must not be pregnant or breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Dato-DXd or Investigator's Choice of Chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Treatment Details
Interventions
- Capecitabine
- Carboplatin
- Dato-DXd
- Eribulin mesylate
Capecitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
- Colorectal cancer
- Breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
AstraZeneca
Lead 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
Daiichi Sankyo, Inc.
Industry Sponsor
Yuki Abe
Daiichi Sankyo, Inc.
Chief Medical Officer since 2022
MD
Hiroyuki Okuzawa
Daiichi Sankyo, Inc.
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University