Breast CancerPhase 3NCT05629585
A Study of Dato-DXd With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Without Pathological Complete Response Following Neoadjuvant Therapy (TROPION-Breast03)
A Phase 3 study testing Dato-DXd, Durvalumab and Capecitabine in people with Breast Cancer, run by AstraZeneca at 276 sites in 17 countries.
Trial summary
This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection… Read more about this study
- Who is it for?
- Ages 18 to 130 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dato-DXd, Durvalumab and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,174 participants
- Where
- 276 sitesin 17 countries
- Study dates
- 28 Nov 2022to 28 Feb 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 130 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must be ≥ 18 years at the time of screening.
- Histologically confirmed invasive TNBC, as defined by the ASCO/CAP guidelines.
- Residual invasive disease in the breast and/or axillary lymph node(s) at surgical resection following neoadjuvant therapy.
- Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline and/or a taxane with or without platinum chemotherapy, with or without pembrolizumab.
- No evidence of locoregional or distant relapse.
- Surgical removal of all clinically evident disease in the breast and lymph nodes.
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- ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to randomisation.
- All participants must provide an FFPE tumour sample from residual invasive disease at surgery for tissue-based analysis.
- No adjuvant systemic therapy.
- Radiotherapy (if indicated) delivered before the start of study intervention.
- If post-operative radiation therapy is given, an interval of no more than 6 weeks between the completion of radiation therapy and the date of randomisation (radiation therapy can be completed during screening period). If no post-operative radiation therapy is given, an interval of no more than 16 weeks between the date of breast surgery and the date of randomisation.
- Has LVEF ≥ 50% by either an ECHO or MUGA scan within 28 days before randomisation.
- Eligible for one of the therapy options listed as investigator's choice per investigator assessment.
- No known germline BRCA1 or BRCA2 pathogenic mutation.
- Adequate bone marrow reserve and organ function within 7 days before randomisation.
Who cannot join
- Stage IV (metastatic) TNBC.
- History of prior invasive breast cancer, or evidence of recurrent disease following preoperative therapy and surgery.
- Severe or uncontrolled medical conditions including systemic diseases, history of allogeneic organ transplant and active bleeding diseases, ongoing or active infection, serious chronic gastrointestinal conditions associated with diarrhea chronic diverticulitis or previous complicated diverticulitis.
- History of another primary malignancy except for adequately resected basal cell carcinoma of the skin or squamous cell carcinoma of the skin, in situ disease (including ductal carcinoma in situ) that has undergone potentially curative therapy, or other solid malignancy treated with curative intent with no known active disease within 5 years before randomisation and of low potential risk for recurrence.
- Persistent toxicities caused by previous anticancer therapy, excluding alopecia, not yet improved to Grade ≤ 1 or baseline. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss).
- Active or prior documented autoimmune or inflammatory disorders.
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- Clinically significant corneal disease.
- Active or uncontrolled hepatitis B or C virus infection.
- Known HIV infection that is not well controlled
- Active tuberculosis infection.
- Mean resting corrected QTcF > 470 ms regardless of gender, obtained from triplicate 12-lead ECGs performed at screening.
- Uncontrolled or significant cardiac disease.
- History of non-infectious ILD/pneumonitis including radiation, pneumonitis that required steroids, has current ILD/pneumonitis, or has suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
- Has severe pulmonary function compromise.
- Any known active liver disease.
- Grade ≥ 2 peripheral neuropathy of any aetiology.
- Prior exposure to a PD-1/PD-L1 inhibitor other than pembrolizumab.
- Current or prior use of immunosuppressive medication within 14 days prior to randomisation.
- Participants with a known severe hypersensitivity to Dato-DXd or any of the excipients of these products including but not limited to polysorbate 80 or other monoclonal antibodies.
- Participants with a known severe hypersensitivity to PD-1/PD-L1 inhibitors.
- Participation in another clinical study with a study intervention or investigational medicinal device administered in the last 4 weeks prior to randomisation, randomisation into a prior Dato-DXd, T-DXd, or durvalumab study regardless of treatment assignment.
- Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.
Trial locations and contacts
276 sites in 17 countries.
276 sites in 17 countries
United States88 sites
Research Site
Albuquerque, New Mexico, 87109
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Altamonte Springs, Florida, 32701
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Annapolis, Maryland, 21401
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Athens, Georgia, 30607
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Atlanta, Georgia, 30318
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Atlanta, Georgia, 30322
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Baltimore, Maryland, 21202
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Bedford, Texas, 76022
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Beverly Hills, California, 90211
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Boston, Massachusetts, 02114
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Camden, New Jersey, 08103
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Canton, Ohio, 44710
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Charlotte, North Carolina, 28204
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Chicago, Illinois, 60611
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Cleveland, Ohio, 44106
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Cleveland, Ohio, 44111
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Cleveland, Ohio, 44195
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Columbia, Maryland, 21044
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Columbus, Ohio, 43219
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Costa Mesa, California, 92627
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Dallas, Texas, 75246
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Denver, Colorado, 80220
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Detroit, Michigan, 48201
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Duarte, California, 91010
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Edmonds, Washington, 98026
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Fairfax, Virginia, 22031
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Fort Worth, Texas, 76104
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Fountain Valley, California, 92708
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Germantown, Tennessee, 38138
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Gilbert, Arizona, 85234
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Hershey, Pennsylvania, 17033
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Hollywood, Florida, 33021
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Hot Springs, Arkansas, 71913
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Houston, Texas, 77024
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Houston, Texas, 77030
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Irvine, California, 92618
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Irving, Texas, 75063
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Issaquah, Washington, 98029
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La Jolla, California, 92093
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Lakewood, California, 90805
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Lexington, Kentucky, 40503
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Little Rock, Arkansas, 72205
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Los Angeles, California, 90017
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Los Angeles, California, 90095
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Louisville, Kentucky, 40202
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Louisville, Kentucky, 40207
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Louisville, Kentucky, 40241
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Maywood, Illinois, 60153
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McAllen, Texas, 78503
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Memphis, Tennessee, 38120
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Miami Beach, Florida, 33140
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Midlothian, Virginia, 23114
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Morgantown, West Virginia, 26506
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Nashville, Tennessee, 37203
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Nashville, Tennessee, 37232
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New Haven, Connecticut, 06510
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New Orleans, Louisiana, 70121
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New York, New York, 10011
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New York, New York, 10021
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New York, New York, 10029
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New York, New York, 10032
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New York, New York, 10065
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Newark, Delaware, 19713
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Newport Beach, California, 92660
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Newport Beach, California, 92663
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Norfolk, Virginia, 23502
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Orange, California, 92868
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Philadelphia, Pennsylvania, 19111
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Pittsburgh, Pennsylvania, 15213
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Portland, Oregon, 97227
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Providence, Rhode Island, 02903
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Puyallup, Washington, 98373
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Reston, Virginia, 20190
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Roseville, California, 95661
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Seattle, Washington, 98104
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Seattle, Washington, 98133
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Spokane Valley, Washington, 99216
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Springdale, Arkansas, 72762
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St Louis, Missouri, 63110
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Tallahassee, Florida, 32308
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Tucson, Arizona, 85711
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Tucson, Arizona, 85719
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Tyler, Texas, 75702
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Upland, California, 91786
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Vallejo, California, 94589
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Washington D.C., District of Columbia, 20007
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West Palm Beach, Florida, 33401
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Westwood, Kansas, 66205
China34 sites
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Beijing, 100044
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Beijing, 100142
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Bengbu, 233004
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Changchun, 130021
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Changsha, 410008
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Chengdu, 610000
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Chengdu, 610072
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Chongqing, 400030
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Fuzhou, 350011
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Guangzhou, 510060
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Guangzhou, 510100
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Guangzhou, 510120
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Guangzhou, 510700
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Haikou, 570311
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Hangzhou, 310009
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Hangzhou, 310020
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Harbin, 150081
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Hefei, 230001
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Jinan, 250030
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Nanchang, 330009
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Nanjing, 210008
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Nanjing, 210009
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Nanning, 530021
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Qingdao, 110016
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Shanghai, 200025
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Shanghai, 200032
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Shenzhen, 518020
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Shijiazhuang, 050020
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Tianjin, 300060
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Wuhan, 430022
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Wuhan, 430060
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Xi'an, 710038
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Xiamen, 361003
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Zhengzhou, 450052
Japan24 sites
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Akashi-shi, 673-8558
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Chiba, 260-8717
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Chūōku, 104-0045
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Fukuoka, 811-1395
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Fukushima, 960-1295
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Hiroshima, 730-8518
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Isehara-shi, 259-1193
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Kashiwa, 277-8577
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Kōtoku, 135-8550
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Kyoto, 606-8507
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Matsuyama, 791-0280
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Nagoya, 464-8681
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Nagoya, 466-8560
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Niigata, 951-8566
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Nishinomiya-shi, 663-8501
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Okayama, 700-8558
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Osaka, 541-8567
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Ota-shi, 373-8550
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Sapporo, 003-0804
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Sendai, 980-8574
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Shinagawa-ku, 142-8666
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Shinjuku-ku, 162-8655
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Tsukuba, 305-8577
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Yokohama, 241-8515
Germany16 sites
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Frankfurt am Main, 65929
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Hamburg, 20357
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Hanover, 30177
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Heilbronn, 74078
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Kiel, 24105
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Langen, 63225
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Leipzig, 4103
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Ludwigsburg, 71640
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Mönchengladbach, 41061
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München, 80337
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Paderborn, 33098
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Regensburg, 93053
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Stuttgart, 70199
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Troisdorf, 53840
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Tübingen, 72076
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Wuppertal, 42283
Canada13 sites
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Barrie, Ontario, L4M 6M2
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Kingston, Ontario, K7L 2V7
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Laval, Quebec, H7M 3L9
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Montreal, Quebec, H2X 0C1
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Montreal, Quebec, H3T 1E2
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Montreal, Quebec, H4A 3J1
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North Vancouver, British Columbia, V7L 2L7
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Oakville, Ontario, L6M 0L8
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Ottawa, Ontario, K1H 8L6
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Québec, Quebec, G1S 4L8
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Saskatoon, Saskatchewan, S7N 4H4
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Toronto, Ontario, M5G 1X5
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Toronto, Ontario, M5G 2M9
Italy13 sites
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Bologna, 40138
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Brescia, 25123
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Florence, 50134
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Genova, 16132
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Livorno, 57124
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Meldola, 47014
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Messina, 98158
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Milan, 20132
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Milan, 20141
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Naples, 80131
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Padova, 35128
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Roma, 00168
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Rozzano, 20089
United Kingdom12 sites
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Cambridge, CB2 0QQ
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Cardiff, CF14 2TL
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Edinburgh, EH4 2XU
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Greater London, SW3 6JJ
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London, EC1A 7BE
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London, SE1 9RT
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Londonderry, BT47 6SB
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Manchester, M20 4BX
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Newcastle upon Tyne, NE7 7AF
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Portsmouth, PO6 3LY
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Surrey, SM2 5PT
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Taunton, TA1 5DA
Belgium11 sites
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Anderlecht, 1070
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Brussels, 1090
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Brussels, 1200
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Charleroi, 6060
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Edegem, 2650
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Ghent, 9000
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Hasselt, 3500
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Liège, 4000
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Namur, 5000
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Sint-Niklaas, 9100
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Wilrijk, 2610
France11 sites
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Angers, 49055
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Bordeaux, 33076
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Dijon, 21000
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Lyon, 69008
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Montpellier, 34070
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Nîmes, 30029
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Paris, 75248
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Poitiers, 86021
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Rennes, 35000
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Saint-Herblain, 44805
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Villejuif, 94805
South Korea10 sites
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Busan, 49241
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Daegu, 41404
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Goyang-si, 10408
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Seongnam-si, 463-712
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Seoul, 02841
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Seoul, 03080
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Seoul, 03722
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Seoul, 05505
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Seoul, 06273
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Seoul, 06351
Spain10 sites
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Barcelona, 08028
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Barcelona, 8035
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Bilbao (Vizcaya), 48013
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Elche(Alicante), 03202
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Madrid, 28040
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Madrid, 28041
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Málaga, 29010
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Palma de Mallorca, 07010
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Toledo, 45007
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Valencia, 46010
Brazil9 sites
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Brasília, 71681-603
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Porto Alegre, 90035-000
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Recife, 52010-075
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Salvador, 41253-190
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São Paulo, 01321-001
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São Paulo, 01508-010
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São Paulo, 03102-002
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São Paulo, 04532-030
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Vitória, 29055-450
Taiwan8 sites
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Hsinchu, 300
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Taichung, 40447
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Tainan, 70403
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Taipei, 10002
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Taipei, 10449
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Taipei, 112
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Taoyuan, 333
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Yung Kang City, 71044
Denmark6 sites
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Copenhagen, 2100
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Herning, 7400
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Næstved, 4700
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Odense, 5000
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Sønderborg, 6400
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Vejle, 7100
Greece6 sites
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Athens, 115 22
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Athens, 11528
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Athens, 12462
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Heraklion, 71110
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Thessaloniki, 54639
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Thessaloniki, 57001
Sweden4 sites
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Stockholm, 11281
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Stockholm, 17176
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Sundsvall, 851 86
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Uppsala, 751 85
About this study
Official title: A Phase 3 Open-label, Randomised Study of Datopotamab Deruxtecan (DatoDXd) With or Without Durvalumab Versus Investigator's Choice of Therapy in Patients With Stage I-III Triple-negative Breast Cancer Who Have Residual Invasive Disease in the Breast and/or Axillary Lymph Nodes at Surgical Resection Following Neoadjuvant Systemic Therapy (TROPION-Breast03)
This is a Phase III, randomized, open-label, 3-arm, multicenter, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with ICT in participants with stage I to III TNBC with residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.
Read the detailed description
The study will investigate the efficacy and safety of Dato-DXd with or without durvalumab when compared with ICT (capecitabine and/or pembrolizumab) in participants with stage I to III TNBC who have residual invasive disease in the breast and/or axillary lymph nodes at surgical resection following neoadjuvant systemic therapy.
The primary objective of the study is to demonstrate superiority of Dato-DXd in combination with durvalumab relative to ICT by assessment of iDFS in participants with stage I to III TNBC with residual invasive disease at surgical resection following neoadjuvant therapy.
- Conditions
- Breast Cancer
- Being tested
- Dato-DXd, Durvalumab, Capecitabine, Pembrolizumab
- Keywords
- Breast Cancer, TNBC, Triple-negative, Adjuvant, Datopotamab Deruxtecan, Dato-DXd, DS1062a, Antibody Drug Conjugate, ADC, TROP2, Durvalumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dato-DXdDrug
Also called Datopotamab deruxtecan (Dato-DXd, DS-1062a)
Experimental drug. Provided in 100mg vials. IV infusion
DurvalumabDrug
Also called MEDI4736
Experimental drug. Provided in 50mg vials. IV infusion
CapecitabineDrug
Also called XELODA®, Capecitabine Cell Pharm, Capecitabine EG, Capecitabine Accord
Active Comparator. Tablet. Oral route of administration
PembrolizumabDrug
Also called KEYTRUDA®
Active Comparator. Provided in 100mg vials. IV infusion
| Study group | Role | What they receive |
|---|---|---|
| Dato-DXd in combination with Durvalumab | Experimental | Arm 1: Dato-DXd 6 mg/kg IV Q3W x 8 cycles + Durvalumab 1120 mg IV Q3W x 9 cycles Receives: Drug: Dato-DXd; Drug: Durvalumab |
| Dato-DXd | Experimental | Arm 2: Dato-DXd 6 mg/kg IV Q3W x 8 cycles Receives: Drug: Dato-DXd |
| Investigators Choice Therapy | Active comparator | Arm 3: Capecitabine (1000 or 1250 mg/m2 oral BID on Days 1 to 14, Q3W) for 8 cycles
Pembrolizumab* (200 mg IV on Day 1, Q3W) for 9 cycles
Capecitabine (1000 or 1250 mg/m2 oral BID on Days 1 to 14, Q3W) for 8 cycles + pembrolizumab* (200 mg IV on Day 1, Q3W) for 9 cycles
* Only participants who have received prior pembrolizumab in the neoadjuvant setting should receive pembrolizumab as part of their adjuvant therapy on Arm 3. Receives: Drug: Capecitabine; Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive disease-free survival (iDFS) for Dato-DXd + durvalumab vs. ICT
iDFS is defined as time from randomisation until date of first occurrence of one of the following events: ipsilateral invasive breast tumour (local) recurrence, regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and skin of ipsilateral breast), or distant recurrence (metastatic breast cancer that has either been biopsy-confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; second primary non-breast invasive cancer (other than squamous or basal cell skin cancer); or death from any cause.
iDFS will be determined based on disease recurrence per investigator assessment based on all available clinical assessments. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy.
The measure of interest will be the HR (hazard ratio) of iDFS for Dato-DXd + durvalumab vs ICT.
Measured: From randomisation to date of the event, up to 57 months from first subject in
Secondary outcomes (13)
Distant disease-free survival (DDFS) for Dato-DXd + durvalumab vs ICT
DDFS is defined as time from randomisation to date of first distant recurrence, occurrence of second primary non-breast invasive cancer, or death from any cause.
DDFS is determined based on disease recurrence per investigators assessment based on all available clinical assessments.
The analysis will include all randomised participants, as randomised regardless of whether the participant withdraws from randomised therapy or received another anticancer therapy. The measure of interest will be the HR (hazard ratio) of DDFS for Dato-DXd + durvalumab vs ICT.
Measured: From randomisation to date of the event, up to 57 months from first subject in
DDFS for Dato-DXd vs ICT
DDFS is defined as time from randomisation to date of first distant recurrence, occurrence of second primary non-breast invasive cancer, or death from any cause. DDFS is determined based on disease recurrence per investigators assessment based on all available clinical assessments. The measure of interest will be the HR (hazard ratio) of DDFS for Dato-DXd vs ICT.
Measured: From randomisation to date of the event, up to 57 months from first subject in
DDFS for Dato-DXd + durvalumab vs Dato-DXd
DDFS is defined as time from randomisation to date of first distant recurrence, occurrence of second primary non-breast invasive cancer, or death from any cause. DDFS is determined based on disease recurrence per investigators assessment based on all available clinical assessments. The measure of interest will be the HR (hazard ratio) of DDFS for Dato-DXd + durvalumab vs Dato-DXd.
Measured: From randomisation to date of the event, up 57 months from first subject in
Overall Survival (OS) for Dato-DXd + durvalumab vs ICT
OS is defined as time from randomisation until date of death due to any cause.
The analysis will include all randomised participants, as randomised regardless of whether the participant withdraws from randomised therapy or received another anticancer therapy. The measure of interest will be the HR (hazard ratio) of OS for Dato-DXd + durvalumab vs ICT.
Measured: From randomisation to date of death, due to any cause, up to 87 months from first subject in
OS for Dato-DXd vs ICT
OS is defined as time from randomisation until date of death due to any cause. The measure of interest will be the HR (hazard ratio) of OS for Dato-DXd vs ICT.
Measured: From randomisation to date of death, due to any cause, up to 87 months from first subject in
iDFS for Dato-DXd vs ICT
iDFS is defined as time from randomisation until date of first occurrence of one of the following events: ipsilateral invasive breast tumour (local) recurrence, regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and skin of ipsilateral breast), or distant recurrence (metastatic breast cancer that has either been biopsy-confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; second primary non-breast invasive cancer (other than squamous or basal cell skin cancer); or death from any cause.
iDFS will be determined based on disease recurrence per investigator assessment based on all available clinical assessments. The analysis will include all randomised participants, as randomised, regardless of whether the participant withdraws from randomised therapy or receives another anticancer therapy.
The measure of interest will be the HR (hazard ratio) of iDFS for Dato-DXd vs ICT.
Measured: From randomisation to date of the event, up to 57 months from first subject in
iDFS for Dato-DXd + durvalumab vs Dato-DXd
iDFS is defined as time from randomisation until date of first occurrence of one of the following events: ipsilateral invasive breast tumour (local) recurrence, regional invasive breast cancer recurrence (axilla, regional lymph nodes, chest wall, and skin of ipsilateral breast), or distant recurrence (metastatic breast cancer that has either been biopsy-confirmed or clinically diagnosed as recurrent invasive breast cancer); contralateral invasive breast cancer; second primary non-breast invasive cancer (other than squamous or basal cell skin cancer); or death from any cause. The measure of interest will be the HR (hazard ratio) of iDFS for Dato-DXd + durvalumab vs Dato-DXd.
Measured: From randomisation to date of the event, up to 57 months from first subject in
Participant-reported physical function in participants treated with Dato-DXd with or without durvalumab compared with ICT
Time to Deterioration (TTD) and actual scores in physical function as measured by the PROMIS Physical Function Short Form 8c.TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold.
The analysis will include all dosed participants. The measure of interest is the HR (hazard ratio) of TTD and mean between-arm difference in physical function for Dato-DXd with or without durvalumab compared with ICT.
Measured: From randomisation to date of the deterioration, up to 36 months after randomisation
Participant-reported in GHS/QoL in participants treated with Dato-DXd with or without durvalumab compared with ICT
Time to Deterioration (TTD) and actual scores in GHS/QoL as measured by the GHS/QoL scale from the EORTC IL172.
TTD is defined as time from the date of randomisation to the date of deterioration. Deterioration is defined as change from baseline that reaches a clinically meaningful deterioration threshold.
The analysis will include all randomised participants. The measure of interest is the HR (hazard ratio) of TTD and mean between-arm difference in GHS/QoL for Dato-DXd with or without durvalumab compared with ICT.
Measured: From randomisation to date of the deterioration, up to 36 months after randomisation
Participant-reported fatigue in participants treated with Dato-DXd with or without durvalumab compared with ICT
Proportion of participants experiencing different levels of fatigue at 3 months (13weeks), 6 months (26 weeks), and 12 months (52 weeks) as measured by PROMIS Fatigue Short Form 7a.
The analysis will include all dosed participants. The measure of interest will be the proportion of participants reporting different levels of fatigue.
Measured: From randomisation to 24 months after randomisation
Pharmacokinetics of Dato-DXd
Concentration of Dato- DXd, total anti-TROP2 antibody, and MAAA-1181 in plasma.
Measured: Day 1 of cycles 1,2,4,6,8 (Each cycle is 21 days)
Immunogenicity of Dato-DXd
Presence of ADAs for Dato-DXd (confirmatory results: positive or negative; titres).
Measured: Day 1 of cycles 1,2,4,6,8 (Each cycle is 21 days) and within 35 days of completion of or discontinuation of study intervention (at an average of 6 months following randomization)
Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability)
Safety and tolerability will be evaluated in terms of AEs (graded by CTCAE version 5.0).
Measured: Randomization to final safety follow-up visit, either 90 days after last dose of study intervention for those who complete planned study intervention or 90 days after date of discontinuation for those who discontinue study intervention prematurely
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start28 Nov 2022
- Primary completion1 Sep 2027 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel
- Masking
- None (open label)
- Enrolment
- 1,174 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daiichi Sankyo, SWOG Clinical Trials Partnerships, LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05629585
- Sponsor's protocol ID
- D926XC00001
- Other IDs
- 2023-505552-22-00, 2022-002680-30, 2023
- Status last verified
- Sep 2026
- First submitted
- 4 Nov 2022
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Publications
Bardia A, Pusztai L, Albain K, Ciruelos EM, Im SA, Hershman D, Kalinsky K, Isaacs C, Loirat D, Testa L, Tokunaga E, Wu J, Dry H, Barlow W, Kozarski R, Maxwell M, Harbeck N, Sharma P. TROPION-Breast03: a randomized phase III global trial of datopotamab deruxtecan +/- durvalumab in patients with triple-negative breast cancer and residual invasive disease at surgical resection after neoadjuvant therapy. Ther Adv Med Oncol. 2024 Apr 29;16:17588359241248336. doi: 10.1177/17588359241248336. eCollection 2024.
PubMed 38686016