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A Phase III Randomised Study to Evaluate Dato-DXd and Durvalumab for Neoadjuvant/Adjuvant Treatment of Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer

NCT06112379

Active Not RecruitingPhase 3

Sponsor: AstraZeneca

Conditions: Breast Cancer

Interventions: Dato-DXd, Durvalumab, Pembrolizumab, Doxorubicin, Epirubicin

Countries: United States, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China

This is a Phase III, 2-arm, randomised, open-label, multicentre, global study assessing the efficacy and safety of neoadjuvant Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without chemotherapy compared with neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab with or without chemotherapy in participants with previously untreated TNBC or hormone receptor-low/HER2-negative breast cancer.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Participant must be ≥ 18 years, at the time of signing the ICF.
* Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer
* ECOG PS of 0 or 1
* Provision of acceptable tumor sample
* Adequate bone marrow reserve and organ function
* Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies and aligned with protocol requirements.

Exclusion criteria:

* History of any prior invasive breast malignancy
* History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 5 years before randomization.
* active or prior documented autoimmune or inflammatory disorders.
* Evidence of distant disease.
* Clinically significant corneal disease.
* Has active or uncontrolled hepatitis B or C virus infection.
* Known HIV infection that is not well controlled.
* Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals; suspected infections; or inability to rule out infections.
* Known to have active tuberculosis infection
* Mean resting corrected QTcF interval \> 470 ms obtained from ECG
* Uncontrolled or significant cardiac disease.
* History of non-infectious ILD/pneumonitis
* Has severe pulmonary function compromise
* Any prior or concurrent surgery, radiotherapy or systemic anticancer therapy for TNBC or hormone receptor-low/HER2-negative breast cancer
* For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding, or planning to become pregnant.
* Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of study intervention, or as dictated by local PI for SoC if longer.
* Concurrent use of systemic hormone replacement therapy or oral hormonal contraception

Locations (283)

Daphne, Alabama, United States
Prescott, Arizona, United States
Jonesboro, Arkansas, United States
Rogers, Arkansas, United States
Los Angeles, California, United States
Santa Barbara, California, United States
Santa Rosa, California, United States
Torrance, California, United States
Aurora, Colorado, United States
Longmont, Colorado, United States
Bridgeport, Connecticut, United States
New Haven, Connecticut, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
St. Petersburg, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Des Moines, Iowa, United States
Edgewood, Kentucky, United States
Louisville, Kentucky, United States
Baton Rouge, Louisiana, United States
Annapolis, Maryland, United States
Boston, Massachusetts, United States
Grand Rapids, Michigan, United States
Traverse City, Michigan, United States
Burnsville, Minnesota, United States
Minneapolis, Minnesota, United States
Columbia, Missouri, United States
Omaha, Nebraska, United States
East Brunswick, New Jersey, United States
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