Dato-DXd for Triple-negative Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the effectiveness of Dato-DXd, an experimental treatment, compared to standard chemotherapy options for triple-negative breast cancer (TNBC), a hard-to-treat type. The trial includes two groups: one receiving Dato-DXd and the other receiving a chemotherapy option chosen by the investigator. Suitable candidates have TNBC that cannot be surgically removed or has metastasized and cannot be treated with certain immunotherapies. As a Phase 3 trial, this study represents the final step before FDA approval, providing patients access to a potentially groundbreaking treatment.
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.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Dato-DXd yields promising results for treating advanced triple-negative breast cancer (TNBC). In earlier studies, patients experienced mostly mild or moderate side effects that could be managed, while serious side effects were less common. Reports indicate that patients generally tolerated the treatment well, even those with extensive prior treatments.
The Investigator's Choice of Chemotherapy (ICC) group includes well-known drugs like capecitabine, carboplatin, and eribulin mesylate. These drugs have been used for other types of cancer and are considered safe. Like many chemotherapy drugs, they can cause side effects, but these are usually known and manageable with medical care.
Overall, past research has shown that both treatment options in the trial are generally safe, with side effects that are typically manageable.12345Why are researchers excited about this trial's treatments?
Dato-DXd is unique because it targets a specific protein called Trop-2 found on the surface of many triple-negative breast cancer cells. This precision approach allows the drug to directly attack cancer cells, potentially leading to better outcomes with fewer side effects compared to traditional chemotherapy. Researchers are excited about Dato-DXd because it combines a potent chemotherapy drug with an antibody that guides it straight to the cancer, offering a new hope for patients whose options are currently limited.
What evidence suggests that this trial's treatments could be effective for triple-negative breast cancer?
Research shows that Dato-DXd, which participants in this trial may receive, is a promising treatment for triple-negative breast cancer (TNBC). Studies indicate it can reduce the risk of cancer progression or death by 43% in patients who cannot use immunotherapy. Specifically, patients taking Dato-DXd lived an average of 23.7 months, five months longer than those receiving standard chemotherapy. The treatment is also considered safe, with fewer serious side effects. This evidence supports Dato-DXd as a strong option for treating TNBC. Another arm of this trial will involve the investigator's choice of chemotherapy, which may include capecitabine, carboplatin, or eribulin, depending on prior treatments.12567
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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