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
NCT ID: NCT06112379
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
1902 participants
INTERVENTIONAL
2023-11-14
2032-09-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Dato-DXd plus durvalumab
Participants receive durvalumab every 3 weeks (Q3W) + Dato-DXd Q3W as neoadjuvant therapy prior to surgery; followed by 9 cycles of durvaluamb Q3W as adjuvant therapy post-surgery. Adjuvant chemotherapy may be given in combination with durvalumab only if participants have residual disease.
Olaparib may be given for participants with gBRCA-positive tumours and residual disease
Adjuvant chemotherapy may be one of these:
1. Doxorubicin (Q3W) or epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks) followed by paclitaxel (weekly) and carboplatin (weekly or Q3W) for 4 cycles (12 weeks);
2. Doxorubicin (Q3W) or epirubicin (Q3W) + cyclophosphamide (Q3W) for 4 cycles (12 weeks) followed by paclitaxel (weekly) for 4 cycles (12 weeks);
3. Carboplatin (weekly or Q3W) + paclitaxel (weekly) for 4 cycles (12 weeks);
4. Capecitabine (Q3W) for 8 cycles.
Dato-DXd
Experimental drug IV infusion
Durvalumab
Experimental drug IV Infusion
Doxorubicin
IV infusion Experimental/Active Comparator
Epirubicin
IV Infusion Experimental/Active Comparator
Cyclophosphamide
IV infusion Experimental/Active Comparator
Paclitaxel
IV infusion Experimental/Active Comparator
Carboplatin
IV infusion Experimental/Active Comparator
Capecitabine
Tablet Oral route of administration Experimental/Active Comparator
Olaparib
Tablet Oral route of administration Experimental/Active Comparator
Pembrolizumab plus chemotherapy
Participants receive pembrolizumab every 3 weeks (Q3W) + paclitaxel weekly + carboplatin (weekly or Q3W) x 4 cycles, followed by pembrolizumab Q3W + (doxorubicin OR epirubicin) + cyclophosphamide Q3W x 4 cycles as neoadjuvant therapy prior to surgery; followed by 9 cycles of pembrolizumab Q3W as adjuvant therapy post-surgery. Adjuvant capecitabine (Q3W) for 8 cycles may be given in combination with pembrolizumab only if participants have residual disease. Olaparib may be given for participants with gBRCA-positive tumours and residual disease.
Pembrolizumab
IV Infusion Active comparator
Doxorubicin
IV infusion Experimental/Active Comparator
Epirubicin
IV Infusion Experimental/Active Comparator
Cyclophosphamide
IV infusion Experimental/Active Comparator
Paclitaxel
IV infusion Experimental/Active Comparator
Carboplatin
IV infusion Experimental/Active Comparator
Capecitabine
Tablet Oral route of administration Experimental/Active Comparator
Olaparib
Tablet Oral route of administration Experimental/Active Comparator
Interventions
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Dato-DXd
Experimental drug IV infusion
Durvalumab
Experimental drug IV Infusion
Pembrolizumab
IV Infusion Active comparator
Doxorubicin
IV infusion Experimental/Active Comparator
Epirubicin
IV Infusion Experimental/Active Comparator
Cyclophosphamide
IV infusion Experimental/Active Comparator
Paclitaxel
IV infusion Experimental/Active Comparator
Carboplatin
IV infusion Experimental/Active Comparator
Capecitabine
Tablet Oral route of administration Experimental/Active Comparator
Olaparib
Tablet Oral route of administration Experimental/Active Comparator
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Daiichi Sankyo
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Daphne, Alabama, United States
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Prescott, Arizona, United States
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Jonesboro, Arkansas, United States
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Rogers, Arkansas, United States
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Los Angeles, California, United States
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Santa Barbara, California, United States
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Santa Rosa, California, United States
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Torrance, California, United States
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Aurora, Colorado, United States
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Longmont, Colorado, United States
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Bridgeport, Connecticut, United States
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New Haven, Connecticut, United States
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Fort Myers, Florida, United States
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Jacksonville, Florida, United States
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St. Petersburg, Florida, United States
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West Palm Beach, Florida, United States
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Atlanta, Georgia, United States
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Des Moines, Iowa, United States
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Edgewood, Kentucky, United States
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Louisville, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Annapolis, Maryland, United States
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Boston, Massachusetts, United States
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Grand Rapids, Michigan, United States
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Traverse City, Michigan, United States
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Burnsville, Minnesota, United States
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Minneapolis, Minnesota, United States
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Columbia, Missouri, United States
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Omaha, Nebraska, United States
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East Brunswick, New Jersey, United States
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New Brunswick, New Jersey, United States
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Santa Fe, New Mexico, United States
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New York, New York, United States
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Charlotte, North Carolina, United States
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Durham, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Blue Ash, Ohio, United States
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Eugene, Oregon, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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El Paso, Texas, United States
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Flower Mound, Texas, United States
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Fort Worth, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Webster, Texas, United States
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Fairfax, Virginia, United States
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Norfolk, Virginia, United States
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Roanoke, Virginia, United States
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Winchester, Virginia, United States
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Tacoma, Washington, United States
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East Melbourne, , Australia
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Feldkirch, , Austria
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Innsbruck, , Austria
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Linz, , Austria
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Salzburg, , Austria
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Antwerp, , Belgium
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Brasschaat, , Belgium
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Charleroi, , Belgium
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Ghent, , Belgium
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Leuven, , Belgium
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Libramont-Chevigny, , Belgium
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Brasília, , Brazil
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Curitiba, , Brazil
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Fortaleza, , Brazil
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Londrina, , Brazil
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Natal, , Brazil
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Porto Alegre, , Brazil
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Porto Alegre, , Brazil
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Ribeirão Preto, , Brazil
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Santo André, , Brazil
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São Paulo, , Brazil
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Taubaté, , Brazil
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Vitória, , Brazil
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Shumen, , Bulgaria
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Sofia, , Bulgaria
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Sofia, , Bulgaria
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Barrie, Ontario, Canada
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London, Ontario, Canada
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Oshawa, Ontario, Canada
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Toronto, Ontario, Canada
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Lévis, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Montreal, , Canada
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Ottawa, , Canada
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Beijing, , China
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Bengbu, , China
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Changchun, , China
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Changsha, , China
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Chengdu, , China
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Guangzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Harbin, , China
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Jinan, , China
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Linhai, , China
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Nanchang, , China
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Nanchang, , China
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Nanjing, , China
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Nanning, , China
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Shanghai, , China
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Shenyang, , China
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Shijiazhuang, , China
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Suining, , China
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Tianjin, , China
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Wuhan, , China
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Xi'an, , China
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Xintai, , China
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Zhaoqing, , China
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Zhengzhou, , China
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Avignon, , France
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Bayonne, , France
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Caen, , France
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Clermont-Ferrand, , France
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Limoges, , France
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Marseille, , France
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Montpellier, , France
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Nice, , France
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Paris, , France
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Reims, , France
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Toulouse, , France
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Vandœuvre-lès-Nancy, , France
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Villejuif, , France
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Augsburg, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Dessau, , Germany
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Dresden, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Esslingen am Neckar, , Germany
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Frankfurt am Main, , Germany
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Freiburg im Breisgau, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Heidelberg, , Germany
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Kiel, , Germany
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Mainz, , Germany
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Mannheim, , Germany
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München, , Germany
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Münster, , Germany
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Trier, , Germany
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Ulm, , Germany
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Hong Kong, , Hong Kong
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Budapest, , Hungary
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Kecskemét, , Hungary
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Miskolc, , Hungary
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Szekszárd, , Hungary
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Bengaluru, , India
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Delhi, , India
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Delhi, , India
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Kolkata, , India
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Kolkata, , India
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Marg Jaipur, , India
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Nagpur, , India
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Nashik, , India
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Thiruvananthapuram, , India
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Vadodara, , India
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Empoli, , Italy
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Lucca, , Italy
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Macerata, , Italy
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Milan, , Italy
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Modena, , Italy
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Napoli, , Italy
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Padua, , Italy
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Roma, , Italy
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Rozzano, , Italy
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Torino, , Italy
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Tricase, , Italy
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Udine, , Italy
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Akashi-shi, , Japan
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Akita, , Japan
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Bunkyō City, , Japan
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Chiba, , Japan
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Chūōku, , Japan
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Chūōku, , Japan
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Fukuoka, , Japan
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Fukushima, , Japan
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Gifu, , Japan
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Hidaka-shi, , Japan
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Hirakata-shi, , Japan
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Hiroshima, , Japan
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Hiroshima, , Japan
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Isehara-shi, , Japan
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Kashiwa, , Japan
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Kumamoto, , Japan
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Kurume-shi, , Japan
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Kyoto, , Japan
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Matsuyama, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Nagoya, , Japan
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Niigata, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Sapporo, , Japan
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Sapporo, , Japan
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Sendai, , Japan
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Shinagawa-ku, , Japan
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Shinjuku-ku, , Japan
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Shinjuku-ku, , Japan
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Sunto-gun, , Japan
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Tsu, , Japan
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Yokohama, , Japan
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George Town, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Selangor, , Malaysia
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Kuching, , Malaysia
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Gdynia, , Poland
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Krakow, , Poland
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Lodz, , Poland
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Warsaw, , Poland
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Singapore, , Singapore
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Daegu, , South Korea
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Goyang-si, , South Korea
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Seongnam, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Granada, , Spain
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Hospitalet deLlobregat, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Santiago de Compostela, , Spain
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Seville, , Spain
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Zaragoza, , Spain
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Baden, , Switzerland
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Basel, , Switzerland
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Bern, , Switzerland
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Frauenfeld, , Switzerland
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Changhua, , Taiwan
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Kaohsiung City, , Taiwan
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Taichung, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Dusit, , Thailand
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Muang, , Thailand
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Songkhla, , Thailand
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Adapazarı, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Kayseri, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
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Birmingham, , United Kingdom
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Cardiff, , United Kingdom
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Lancaster, , United Kingdom
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London, , United Kingdom
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Northampton, , United Kingdom
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Oxford, , United Kingdom
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Taunton, , United Kingdom
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Hanoi, , Vietnam
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Ho Chi Minh City, , Vietnam
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Hồ Chí Minh, , Vietnam
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Vinh, , Vietnam
Countries
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References
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McArthur HL, Tolaney SM, Dent R, Schmid P, Asselah J, Liu Q, Meisel JL, Niikura N, Park YH, Werutsky G, Bianchini G, Andersen JC, Kozarski R, Rokutanda N, Pistilli B, Loibl S. TROPION-Breast04: a randomized phase III study of neoadjuvant datopotamab deruxtecan (Dato-DXd) plus durvalumab followed by adjuvant durvalumab versus standard of care in patients with treatment-naive early-stage triple negative or HR-low/HER2- breast cancer. Ther Adv Med Oncol. 2025 Feb 5;17:17588359251316176. doi: 10.1177/17588359251316176. eCollection 2025.
Related Links
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Breast Cancer Study Locator details (for US)
Other Identifiers
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2023-505928-59-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D926QC00001
Identifier Type: -
Identifier Source: org_study_id