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
Launched by ASTRAZENECA · Oct 31, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying two different treatment approaches for patients with triple-negative breast cancer (TNBC) or hormone receptor-low/HER2-negative breast cancer. The goal is to see how effective and safe a new combination of medications called Dato-DXd and durvalumab is compared to an existing treatment that involves pembrolizumab and chemotherapy. Participants will receive these treatments before surgery (neoadjuvant) and may continue with additional therapy after surgery (adjuvant) to help prevent cancer from coming back.
To be eligible for this trial, participants must be at least 18 years old and have a confirmed diagnosis of Stage II or III breast cancer that fits the specific criteria. They should have good overall health, as determined by a performance status scale. Participants can expect regular check-ups and monitoring throughout the study, and they will need to provide a tumor sample for testing. It's important to know that certain medical conditions and treatments may prevent someone from joining the trial, such as having another active cancer or specific infections. Overall, this study aims to find better treatment options for patients facing these types of breast cancer.
Gender
ALL
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
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Los Angeles, California, United States
Durham, North Carolina, United States
Houston, Texas, United States
Hong Kong, , Hong Kong
Fairfax, Virginia, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Norfolk, Virginia, United States
Plovdiv, , Bulgaria
Shumen, , Bulgaria
Detroit, Michigan, United States
Brasschaat, , Belgium
Gent, , Belgium
Nyíregyháza, , Hungary
Marg Jaipur, , India
Aurora, Colorado, United States
Guildford, , United Kingdom
Tacoma, Washington, United States
Atlanta, Georgia, United States
Minneapolis, Minnesota, United States
El Paso, Texas, United States
Bethesda, Maryland, United States
Dresden, , Germany
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Kiel, , Germany
Milano, , Italy
Barcelona, , Spain
Zaragoza, , Spain
Bakersfield, California, United States
Fullerton, California, United States
Santa Barbara, California, United States
Charlotte, North Carolina, United States
Leuven, , Belgium
Wilrijk, , Belgium
Calgary, Alberta, Canada
Toronto, Ontario, Canada
Paris, , France
Napoli, , Italy
Padova, , Italy
Bialystok, , Poland
Warszawa, , Poland
Miskolc, , Hungary
Vratza, , Bulgaria
Nice, , France
Philadelphia, Pennsylvania, United States
Erlangen, , Germany
Torino, , Italy
Feldkirch, , Austria
Graz, , Austria
Innsbruck, , Austria
Linz, , Austria
Salzburg, , Austria
Heidelberg, , Australia
Charleroi, , Belgium
Basel, , Switzerland
Los Angeles, California, United States
New Haven, Connecticut, United States
Pittsburgh, Pennsylvania, United States
Orange, California, United States
Oshawa, Ontario, Canada
Bydgoszcz, , Poland
Gdańsk, , Poland
Levis, Quebec, Canada
Sylmar, California, United States
Bridgeport, Connecticut, United States
Saint Petersburg, Florida, United States
Annapolis, Maryland, United States
Grand Rapids, Michigan, United States
Saint Louis, Missouri, United States
Winston Salem, North Carolina, United States
Canton, Ohio, United States
Chattanooga, Tennessee, United States
Dallas, Texas, United States
Roanoke, Virginia, United States
St. John's, Newfoundland And Labrador, Canada
Montreal, Quebec, Canada
Sherbrooke, Quebec, Canada
Hamburg, , Germany
Heidelberg, , Germany
Mainz, , Germany
Udine, , Italy
Gdynia, , Poland
Richmond, Virginia, United States
Jonesboro, Arkansas, United States
Omaha, Nebraska, United States
Tallahassee, Florida, United States
Eugene, Oregon, United States
Herston, , Australia
Atlanta, Georgia, United States
New Brunswick, New Jersey, United States
New York, New York, United States
Newark, Delaware, United States
Portland, Oregon, United States
Freiburg, , Germany
Münster, , Germany
Hospitalet Dellobregat, , Spain
Wroclaw, , Poland
Austin, Texas, United States
Roma, , Italy
Samsun, , Turkey
Jacksonville, Florida, United States
Reims Cedex, , France
East Melbourne, , Australia
Providence, Rhode Island, United States
Villejuif Cedex, , France
Tainan, , Taiwan
Budapest, , Hungary
Kecskemét, , Hungary
Camden, New Jersey, United States
West Palm Beach, Florida, United States
Madrid, , Spain
Oxford, , United Kingdom
Port Saint Lucie, Florida, United States
Jacksonville, Florida, United States
Fort Collins, Colorado, United States
Sevilla, , Spain
Fort Myers, Florida, United States
Santa Fe, New Mexico, United States
Fort Worth, Texas, United States
Irving, Texas, United States
Webster, Texas, United States
São Paulo, , Brazil
Chongqing, , China
Shanghai, , China
Taichung, , Taiwan
Rozzano, , Italy
Hannover, , Germany
Bern, , Switzerland
Commack, New York, United States
Modena, , Italy
Tianjin, , China
Cardiff, , United Kingdom
London, Ontario, Canada
Tucson, Arizona, United States
Newport Beach, California, United States
Des Moines, Iowa, United States
Traverse City, Michigan, United States
Winchester, Virginia, United States
Madison, Wisconsin, United States
Thiruvananthapuram, , India
Chuo Ku, , Japan
Fukuoka Shi, , Japan
Niigata Shi, , Japan
Sapporo Shi, , Japan
Taipei, , Taiwan
Barrie, Ontario, Canada
Trier, , Germany
Matsuyama Shi, , Japan
Torrance, California, United States
Beijing, , China
Hangzhou, , China
Nanning, , China
Suzhou, , China
Szekszárd, , Hungary
Kuching, , Malaysia
Changhua, , Taiwan
Northampton, , United Kingdom
Bayonne, , France
Koto Ku, , Japan
Mannheim, , Germany
Tokyo, , Japan
Sunto Gun, , Japan
Essen, , Germany
Clermont Ferrand, , France
Augsburg, , Germany
Montpellier, , France
Marseille, , France
Berlin, , Germany
Edgewood, Kentucky, United States
Ulm, , Germany
Changchun, , China
Kunming, , China
Wuhan, , China
Xi'an, , China
Lyon, , France
Sendai Shi, , Japan
Kraków, , Poland
Abbotsford, British Columbia, Canada
Guangzhou, , China
Kumamoto Shi, , Japan
Sofia, , Bulgaria
Chiba Shi, , Japan
Goodyear, Arizona, United States
London, , United Kingdom
Frankfurt Am Main, , Germany
Phoenix, Arizona, United States
Henderson, Nevada, United States
Limoges, , France
Darlinghurst, , Australia
Seoul, , Korea, Republic Of
Santiago De Compostela, , Spain
Hanoi, , Vietnam
Ho Chi Minh City, , Vietnam
Falls Church, Virginia, United States
Changsha, , China
Tsu Shi, , Japan
Columbia, Missouri, United States
Nedlands, , Australia
Hirakata Shi, , Japan
Kashiwa, , Japan
Shinjuku Ku, , Japan
Caen Cedex 5, , France
Waratah, , Australia
Lucca, , Italy
Saint Herblain, , France
Bengbu, , China
Urumqi, , China
Zhengzhou, , China
Sapporo Shi, , Japan
Yokohama Shi, , Japan
Taoyuan, , Taiwan
Saskatoon, Saskatchewan, Canada
Osaka Shi, , Japan
Kyoto Shi, , Japan
East Brunswick, New Jersey, United States
Isehara Shi, , Japan
Kurume Shi, , Japan
Shinagawa Ku, , Japan
Daegu, , Korea, Republic Of
Kayseri, , Turkey
Shijiazhuang, , China
Avignon, , France
Esslingen Am Neckar, , Germany
Hidaka Shi, , Japan
Goyang Si, , Korea, Republic Of
łódź, , Poland
Blue Ash, Ohio, United States
Akashi Shi, , Japan
Nagoya Shi, , Japan
Muang, , Thailand
Van Nuys, California, United States
Libramont Chevigny, , Belgium
Bunkyo Ku, , Japan
Kaohsiung, , Taiwan
Harbin, , China
Salgótarján, , Hungary
George Town, , Malaysia
Fukushima Shi, , Japan
Toulouse, , France
Rogers, Arkansas, United States
Vandoeuvre Les Nancy, , France
Santo Andre, , Brazil
Okayama, , Japan
Nanchang, , China
Linhai, , China
Nanjing, , China
Taunton, , United Kingdom
Lancaster, , United Kingdom
Istanbul, , Turkey
Akita Shi, , Japan
Fortaleza, , Brazil
Ottawa, , Canada
Vancouver, British Columbia, Canada
Flower Mound, Texas, United States
Hiroshima Shi, , Japan
Tomaszów Mazowiecki, , Poland
Bangkok, , Thailand
Songkhla, , Thailand
Granada, , Spain
Kuala Lumpur, , Malaysia
Seongnam, , Korea, Republic Of
Chengdu, , China
Essen, , Germany
München, , Germany
Macerata, , Italy
Frauenfeld, , Switzerland
Adapazari, , Turkey
Tianjin, , China
Hong Kong, , Hong Kong
Londrina, , Brazil
Port Jefferson Station, New York, United States
Natal, , Brazil
Xintai, , China
Kwai Chung, , Hong Kong
San Antonio, Texas, United States
Jinan, , China
Nagpur, , India
Selangor, , Malaysia
Delhi, , India
Baton Rouge, Louisiana, United States
Ribeirão Preto, , Brazil
Porto Alegre, , Brazil
Ankara, , Turkey
Gifu Shi, , Japan
Nashik, , India
Dusit, , Thailand
Santa Rosa, California, United States
Brasilia, , Brazil
Curitiba, , Brazil
Chicago Ridge, Illinois, United States
Vadodara, , India
Delhi, , India
Shenyang, , China
Burnsville, Minnesota, United States
Vitória, , Brazil
Tricase, , Italy
Taubaté, , Brazil
Puducherry, , India
Longmont, Colorado, United States
St Jerome, Quebec, Canada
Samsun, , Turkey
Singapore, , Singapore
Hefei, , China
Suining, , China
Dyer, Indiana, United States
Linhai, , China
Dallas, Texas, United States
Angers, , France
Empoli, , Italy
Rennaz, , Switzerland
Edinburgh, , United Kingdom
Dessau Roßlau, , Germany
Bengaluru, , India
Dehradun, , India
Kolkata, , India
Vinh, , Vietnam
Birmingham, , United Kingdom
Horsham, Pennsylvania, United States
Baden, , Switzerland
Daphne, Alabama, United States
Irvine, California, United States
Charleroi, , Belgium
Calgary, Alberta, Canada
Zhaoqing, , China
Bengbu, , China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported