New hope for tough breast cancer: drug combo targets remaining disease after surgery

NCT ID NCT05629585

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This Phase 3 trial tests whether a new drug, datopotamab deruxtecan (Dato-DXd), given alone or with another drug (durvalumab), can help prevent breast cancer from returning in people with triple-negative breast cancer who still have cancer cells after initial treatment and surgery. About 1,174 participants will be randomly assigned to one of three groups: Dato-DXd alone, Dato-DXd plus durvalumab, or standard therapy. The main goal is to see how long people live without their cancer coming back.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Datopotamab deruxtecan (Dato-DXd) and durvalumab
What this could lead to: If successful, this could offer a more effective treatment option for triple-negative breast cancer patients who still have cancer after initial therapy, potentially reducing the chance of the cancer returning.
What could go wrong: This is an early-stage Phase 3 trial, and the experimental drugs may not prove better than existing treatments. Side effects from the combination therapy could be significant.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,174 people

The number who actually took part.

Started

Nov 2022

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 130 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant must be ≥ 18 years at the time of screening. 2. Histologically confirmed invasive TNBC, as defined by the ASCO/CAP guidelines. 3. Residual invasive disease in the breast and/or axillary lymph node(s) at surgical resection following neoadjuvant therapy. 4. Completed at least 6 cycles of neoadjuvant therapy containing an anthracycline and/or a taxane with or without platinum chemotherapy, with or without pembrolizumab. 5. No evidence of locoregional or distant relapse. 6. Surgical removal of all clinically evident disease in the breast and lymph nodes. 7. ECOG performance status of 0 or 1 with no deterioration over the previous 2 weeks prior to randomisation. 8. All participants must provide an FFPE tumour sample from residual invasive disease at surgery for tissue-based analysis. 9. No adjuvant systemic therapy. 10. Radiotherapy (if indicated) delivered before the start of study intervention. 11. 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. 12. Has LVEF ≥ 50% by either an ECHO or MUGA scan within 28 days before randomisation. 13. Eligible for one of the therapy options listed as investigator's choice per investigator assessment. 14. No known germline BRCA1 or BRCA2 pathogenic mutation. 15. Adequate bone marrow reserve and organ function within 7 days before randomisation. Exclusion Criteria: 1. Stage IV (metastatic) TNBC. 2. History of prior invasive breast cancer, or evidence of recurrent disease following preoperative therapy and surgery. 3. 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. 4. 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. 5. 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). 6. Active or prior documented autoimmune or inflammatory disorders. 7. Clinically significant corneal disease. 8. Active or uncontrolled hepatitis B or C virus infection. 9. Known HIV infection that is not well controlled 10. Active tuberculosis infection. 11. Mean resting corrected QTcF \> 470 ms regardless of gender, obtained from triplicate 12-lead ECGs performed at screening. 12. Uncontrolled or significant cardiac disease. 13. 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. 14. Has severe pulmonary function compromise. 15. Any known active liver disease. 16. Grade ≥ 2 peripheral neuropathy of any aetiology. 17. Prior exposure to a PD-1/PD-L1 inhibitor other than pembrolizumab. 18. Current or prior use of immunosuppressive medication within 14 days prior to randomisation. 19. 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. 20. Participants with a known severe hypersensitivity to PD-1/PD-L1 inhibitors. 21. 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. 22. Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

Research Site

Gilbert, Arizona, 85234, United States
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Tucson, Arizona, 85711, United States
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Tucson, Arizona, 85719, United States
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Hot Springs, Arkansas, 71913, United States
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Little Rock, Arkansas, 72205, United States
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Springdale, Arkansas, 72762, United States
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Beverly Hills, California, 90211, United States
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Costa Mesa, California, 92627, United States
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Duarte, California, 91010, United States
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Fountain Valley, California, 92708, United States
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Irvine, California, 92618, United States
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La Jolla, California, 92093, United States
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Lakewood, California, 90805, United States
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Los Angeles, California, 90017, United States
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Los Angeles, California, 90095, United States
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Newport Beach, California, 92660, United States
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Newport Beach, California, 92663, United States
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Orange, California, 92868, United States
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Roseville, California, 95661, United States
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Upland, California, 91786, United States
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Vallejo, California, 94589, United States
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Denver, Colorado, 80220, United States
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New Haven, Connecticut, 06510, United States
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Newark, Delaware, 19713, United States
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Washington D.C., District of Columbia, 20007, United States
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Altamonte Springs, Florida, 32701, United States
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Hollywood, Florida, 33021, United States
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Miami Beach, Florida, 33140, United States
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Tallahassee, Florida, 32308, United States
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West Palm Beach, Florida, 33401, United States
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Athens, Georgia, 30607, United States
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Atlanta, Georgia, 30318, United States
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Atlanta, Georgia, 30322, United States
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Chicago, Illinois, 60611, United States
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Maywood, Illinois, 60153, United States
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Westwood, Kansas, 66205, United States
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Lexington, Kentucky, 40503, United States
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Louisville, Kentucky, 40202, United States
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Louisville, Kentucky, 40207, United States
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Louisville, Kentucky, 40241, United States
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New Orleans, Louisiana, 70121, United States
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Annapolis, Maryland, 21401, United States
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Baltimore, Maryland, 21202, United States
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Columbia, Maryland, 21044, United States
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Boston, Massachusetts, 02114, United States
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Detroit, Michigan, 48201, United States
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St Louis, Missouri, 63110, United States
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Camden, New Jersey, 08103, United States
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Albuquerque, New Mexico, 87109, United States
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New York, New York, 10011, United States
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New York, New York, 10021, United States
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New York, New York, 10029, United States
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New York, New York, 10032, United States
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New York, New York, 10065, United States
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Charlotte, North Carolina, 28204, United States
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Canton, Ohio, 44710, United States
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Cleveland, Ohio, 44106, United States
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Cleveland, Ohio, 44111, United States
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Cleveland, Ohio, 44195, United States
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Columbus, Ohio, 43219, United States
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Portland, Oregon, 97227, United States
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Hershey, Pennsylvania, 17033, United States
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Philadelphia, Pennsylvania, 19111, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Providence, Rhode Island, 02903, United States
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Germantown, Tennessee, 38138, United States
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Memphis, Tennessee, 38120, United States
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Nashville, Tennessee, 37203, United States
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Nashville, Tennessee, 37232, United States
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Bedford, Texas, 76022, United States
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Dallas, Texas, 75246, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77024, United States
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Houston, Texas, 77030, United States
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Irving, Texas, 75063, United States
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McAllen, Texas, 78503, United States
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Tyler, Texas, 75702, United States
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Fairfax, Virginia, 22031, United States
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Midlothian, Virginia, 23114, United States
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Norfolk, Virginia, 23502, United States
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Reston, Virginia, 20190, United States
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Edmonds, Washington, 98026, United States
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Issaquah, Washington, 98029, United States
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Puyallup, Washington, 98373, United States
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Seattle, Washington, 98104, United States
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Seattle, Washington, 98133, United States
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Spokane Valley, Washington, 99216, United States
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Morgantown, West Virginia, 26506, United States
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Anderlecht, 1070, Belgium
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Brussels, 1090, Belgium
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Brussels, 1200, Belgium
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Charleroi, 6060, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Hasselt, 3500, Belgium
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Liège, 4000, Belgium
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Namur, 5000, Belgium
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Sint-Niklaas, 9100, Belgium
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Wilrijk, 2610, Belgium
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Brasília, 71681-603, Brazil
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Porto Alegre, 90035-000, Brazil
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Recife, 52010-075, Brazil
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Salvador, 41253-190, Brazil
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São Paulo, 01321-001, Brazil
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São Paulo, 01508-010, Brazil
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São Paulo, 03102-002, Brazil
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São Paulo, 04532-030, Brazil
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Vitória, 29055-450, Brazil
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North Vancouver, British Columbia, V7L 2L7, Canada
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Barrie, Ontario, L4M 6M2, Canada
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Kingston, Ontario, K7L 2V7, Canada
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Oakville, Ontario, L9T 6G2, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G 1X5, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Laval, Quebec, H7M 3L9, Canada
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Montreal, Quebec, H2X 0C1, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Québec, Quebec, G1S 4L8, Canada
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Saskatoon, Saskatchewan, S7N 4H4, Canada
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Beijing, 100044, China
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Beijing, 100142, China
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Bengbu, 233004, China
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Changchun, 130021, China
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Changsha, 410008, China
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Chengdu, 610000, China
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Chengdu, 610072, China
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Chongqing, 400030, China
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Fuzhou, 350011, China
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Guangzhou, 510060, China
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Guangzhou, 510100, China
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Guangzhou, 510120, China
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Guangzhou, 510700, China
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Haikou, 570311, China
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Hangzhou, 310009, China
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Hangzhou, 310020, China
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Harbin, 150081, China
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Hefei, 230001, China
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Jinan, 250030, China
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Nanchang, 330009, China
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Nanjing, 210008, China
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Nanjing, 210009, China
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Nanning, 530021, China
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Qingdao, 110016, China
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Shanghai, 200025, China
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Shanghai, 200032, China
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Shenzhen, 518020, China
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Shijiazhuang, 050020, China
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Tianjin, 300060, China
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Wuhan, 430022, China
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Wuhan, 430060, China
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Xi'an, 710038, China
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Xiamen, 361003, China
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Zhengzhou, 450052, China
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Copenhagen, 2100, Denmark
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Herning, 7400, Denmark
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Næstved, 4700, Denmark
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Odense, 5000, Denmark
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Sønderborg, 6400, Denmark
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Vejle, 7100, Denmark
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Angers, 49055, France
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Bordeaux, 33076, France
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Dijon, 21000, France
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Lyon, 69008, France
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Montpellier, 34070, France
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Nîmes, 30029, France
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Paris, 75248, France
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Poitiers, 86021, France
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Rennes, 35000, France
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Saint-Herblain, 44805, France
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Villejuif, 94805, France
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Frankfurt am Main, 65929, Germany
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Hamburg, 20357, Germany
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Hanover, 30177, Germany
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Heilbronn, 74078, Germany
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Kiel, 24105, Germany
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Langen, 63225, Germany
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Leipzig, 4103, Germany
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Ludwigsburg, 71640, Germany
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Mönchengladbach, 41061, Germany
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München, 80337, Germany
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Paderborn, 33098, Germany
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Regensburg, 93053, Germany
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Stuttgart, 70199, Germany
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Troisdorf, 53840, Germany
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Tübingen, 72076, Germany
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Wuppertal, 42283, Germany
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Athens, 115 22, Greece
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Athens, 11528, Greece
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Athens, 12462, Greece
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Heraklion, 71110, Greece
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Thessaloniki, 54639, Greece
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Thessaloniki, 57001, Greece
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Bologna, 40138, Italy
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Brescia, 25123, Italy
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Florence, 50134, Italy
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Genova, 16132, Italy
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Livorno, 57124, Italy
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Meldola, 47014, Italy
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Messina, 98158, Italy
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Milan, 20132, Italy
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Milan, 20141, Italy
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Naples, 80131, Italy
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Padova, 35128, Italy
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Roma, 00168, Italy
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Rozzano, 20089, Italy
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Akashi-shi, 673-8558, Japan
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Chiba, 260-8717, Japan
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Chūōku, 104-0045, Japan
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Fukuoka, 811-1395, Japan
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Fukushima, 960-1295, Japan
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Hiroshima, 730-8518, Japan
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Isehara-shi, 259-1193, Japan
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Kashiwa, 277-8577, Japan
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Kōtoku, 135-8550, Japan
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Kyoto, 606-8507, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 464-8681, Japan
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Nagoya, 466-8560, Japan
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Niigata, 951-8566, Japan
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Nishinomiya-shi, 663-8501, Japan
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Okayama, 700-8558, Japan
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Osaka, 541-8567, Japan
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Ota-shi, 373-8550, Japan
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Sapporo, 003-0804, Japan
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Sendai, 980-8574, Japan
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Shinagawa-ku, 142-8666, Japan
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Shinjuku-ku, 162-8655, Japan
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Tsukuba, 305-8577, Japan
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Yokohama, 241-8515, Japan
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San Juan, 00918, Puerto Rico
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Busan, 49241, South Korea
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Daegu, 41404, South Korea
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Goyang-si, 10408, South Korea
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Seongnam-si, 463-712, South Korea
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Seoul, 02841, South Korea
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Seoul, 03080, South Korea
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Seoul, 03722, South Korea
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Seoul, 05505, South Korea
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Seoul, 06273, South Korea
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Seoul, 06351, South Korea
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Barcelona, 08028, Spain
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Barcelona, 8035, Spain
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Bilbao (Vizcaya), 48013, Spain
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Elche(Alicante), 03202, Spain
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Madrid, 28040, Spain
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Madrid, 28041, Spain
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Málaga, 29010, Spain
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Palma de Mallorca, 07010, Spain
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Toledo, 45007, Spain
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Valencia, 46010, Spain
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Stockholm, 11281, Sweden
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Stockholm, 17176, Sweden
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Sundsvall, 851 86, Sweden
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Uppsala, 751 85, Sweden
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Hsinchu, 300, Taiwan
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Taichung, 40447, Taiwan
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Tainan, 70403, Taiwan
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Taipei, 10002, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 112, Taiwan
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Taoyuan, 333, Taiwan
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Yung Kang City, 71044, Taiwan
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Cambridge, CB2 0QQ, United Kingdom
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Cardiff, CF14 2TL, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Greater London, SW3 6JJ, United Kingdom
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London, EC1A 7BE, United Kingdom
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London, SE1 9RT, United Kingdom
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Londonderry, BT47 6SB, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Newcastle upon Tyne, NE7 7AF, United Kingdom
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Portsmouth, PO6 3LY, United Kingdom
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Surrey, SM2 5PT, United Kingdom
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Taunton, TA1 5DA, United Kingdom

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