A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab

Clinical Trial Details

This clinical trial is for adult participants who have triple-negative breast cancer (TNBC).

The purpose of this study is to evaluate the safety and effectiveness of the study drug datopotamab deruxtecan (also called Dato-DXd) given in combination with another investigational drug called durvalumab.

Dato-DXd and Durvalumab are experimental, which means that they are being tested and are not approved by the United States Food and Drug Administration (FDA).

Dato-DXd and Durvalumab will be administered via IV infusion. Participants may also receive a combination of some of the following products: pembrolizumab, doxorubicin, epirubicin, cyclophosphamide paclitaxel, carboplatin, carboplatin, or olaparib. All of the products will be provided via IV infusion with the exception of carboplatin and olaparib which will be given orally.

Participation is expected to last about 7 years.

Key Eligibility:

Open to men and women above the age of 18 who have been diagnosed with triple-negative breast cancer (TNBC) and HR-low/HER2-negative breast cancer.
Participants must not have uncontrolled or significant cardiac disease including but not limited to myocardial infarction or uncontrolled/unstable angina and congestive heart failure.

Detailed eligibility will be reviewed when you contact the study team.

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Devonie Manzano, RN
212-746-7117
dgm4004@med.cornell.edu

Brooklyn

Contact(s)

Kate Santoso
929-470-9507
bnk9002@med.cornell.edu

Primary Investigator(s)

Ashley Schreier, DO (UES)

Evelyn Attia, MD (BRK)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2310026645

ClinicalTrials.gov:

NCT06112379

Status

Open to Enrollment

Age Group

Adult

Disease

Breast Cancer