New hope for aggressive breast cancer: drug combo trial launches

NCT ID NCT06103864

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 4 times

Summary

This Phase 3 trial is testing whether a new drug called datopotamab deruxtecan (Dato-DXd), given alone or with another drug called durvalumab, works better than standard chemotherapy for people with a certain type of advanced triple-negative breast cancer (PD-L1 positive). About 625 participants will be randomly assigned to one of three treatment groups. The main goal is to see if the new combinations delay cancer growth or improve survival.

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 new, more effective treatment option for people with advanced triple-negative breast cancer that has PD-L1 expression, potentially improving how long they live without their cancer growing.
What could go wrong: This is an early-stage Phase 3 trial, so results are not yet known. The experimental drugs may not work better than current chemotherapy, and they could have serious side effects. The study only includes people with a specific biomarker (PD-L1 positive), so findings may not apply to all patients.

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

About 625 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Sep 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 years and older

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.

Key Inclusion Criteria * Histologically or cytologically documented locally recurrent inoperable, which cannot be treated with curative intent, or metastatic TNBC, as defined by the ASCO-CAP guidelines. * ECOG PS 0 or 1. * Participants are expected to provide an FFPE tumour sample collected from a locally recurrent inoperable or metastatic tumour. Alternatively, an archival FFPE tumour sample can be submitted; it must have been collected ≤ 3 years prior to the participant signing informed consent (screening start). * PD-L1 positive TNBC based on results from an appropriately validated investigational PD-L1 (22C3) assay (CPS ≥ 10) from a sponsor designated central laboratory. * No prior chemotherapy or other systemic anti-cancer therapy for metastatic or locally recurrent inoperable breast cancer. \- Patients with recurrent disease will be eligible if they have completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months have elapsed between completion of treatment with curative intent and the first documented recurrence. * Eligible for one of the chemotherapy options listed as ICC (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin). * Measurable disease as per RECIST 1.1. * Adequate bone marrow reserve and organ function. * Male and female participants of childbearing potential must agree to use protocol-specified method(s) of contraception. Key Exclusion Criteria * As judged by investigator, any evidence of diseases (such as severe or uncontrolled medical conditions including systemic diseases, uncontrolled hypertension, serious gastrointestinal conditions associated with diarrhoea, chronic diverticulitis or previous complicated diverticulitis, history of allogeneic organ transplant, and active bleeding diseases, ongoing and active infection, significant cardiac conditions, substance abuse, psychiatric illness/social situation or psychological conditions) which, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol. * History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 2 years before Cycle 1 Day 1 and of low potential risk for recurrence. * Participants with a history of previously treated neoplastic spinal cord compression or treated, clinically inactive brain metastases that are no longer symptomatic, who require no treatment with corticosteroids or anticonvulsants, may be included in the study if they have recovered from acute toxic effects of radiotherapy. \- Participants with treated clinically inactive brain metastases that are no longer symptomatic, who require no treatment with corticosteroids or anticonvulsants, may be included in the study if they have recovered from acute toxic effects of radiotherapy. * Uncontrolled infection requiring IV antibiotics, antivirals or antifungals. * Active or uncontrolled hepatitis B or C virus infection. * Known HIV infection that is not well controlled. * Uncontrolled or significant cardiac disease. * History of non-infectious ILD/pneumonitis (including radiation pneumonitis) that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. * Clinically severe pulmonary function compromise. * Clinically significant corneal disease. * Active or prior documented autoimmune or inflammatory disorders. * Prior exposure to any treatment including ADC containing a chemotherapeutic agent targeting topoisomerase I and TROP2-targeted therapy. * Any concurrent anti-cancer treatment. * Participants with a known severe hypersensitivity to PD-1/PD-L1 inhibitors or Dato-DXd. * Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.

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Get notified about this study

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Neoplasm Metastasis triple-negative breast carcinoma

As listed by the trial registrant

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

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

250 sites in 23 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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Daphne, Alabama, 36526, United States
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Springdale, Arkansas, 72762, United States
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Duarte, California, 91010, United States
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NOT_YET_RECRUITING

Fountain Valley, California, 92708, United States
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Glendale, California, 91204, United States
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Sacramento, California, 95817, United States
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Santa Rosa, California, 95403, United States
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Aurora, Colorado, 80012, United States
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Denver, Colorado, 80210, United States
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New Haven, Connecticut, 06510, United States
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Altamonte Springs, Florida, 32701, United States
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Jacksonville, Florida, 32256, United States
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Miami, Florida, 33176, United States
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Palm Bay, Florida, 32909, United States
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Plantation, Florida, 33324, United States
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SUSPENDED

Atlanta, Georgia, 30318, United States
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Honolulu, Hawaii, 96819, United States
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Chicago, Illinois, 60637, United States
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Decatur, Illinois, 62526, United States
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Elmhurst, Illinois, 60126, United States
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Naperville, Illinois, 60540, United States
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New Albany, Indiana, 47150, United States
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Des Moines, Iowa, 50309, 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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Baton Rouge, Louisiana, 70808, United States
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Baton Rouge, Louisiana, 70809, United States
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Baltimore, Maryland, 21215, United States
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Columbia, Maryland, 21044, United States
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Boston, Massachusetts, 02111, United States
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Worcester, Massachusetts, 01655, United States
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Detroit, Michigan, 48201, United States
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Grand Rapids, Michigan, 49503, United States
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Saint Paul, Minnesota, 55109, United States
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Hattiesburg, Mississippi, 39401, United States
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St Louis, Missouri, 63129, United States
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Albuquerque, New Mexico, 87109, United States
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Albany, New York, 12206, United States
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New York, New York, 10065, United States
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Stony Brook, New York, 11794-7263, United States
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Cincinnati, Ohio, 45219, United States
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Cincinnati, Ohio, 45245, United States
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Cleveland, Ohio, 44195, United States
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York, Pennsylvania, 17403, United States
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Providence, Rhode Island, 02903, United States
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Chattanooga, Tennessee, 37404, United States
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Nashville, Tennessee, 37203, United States
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Dallas, Texas, 75230, United States
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Dallas, Texas, 75246, United States
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Dallas, Texas, 75246, United States
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El Paso, Texas, 79902, United States
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Flower Mound, Texas, 75028, United States
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Fort Worth, Texas, 76104, United States
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Houston, Texas, 77054, United States
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Houston, Texas, 77090, United States
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Houston, Texas, 77098, United States
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Kingwood, Texas, 77339, United States
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McKinney, Texas, 75071, United States
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Sugar Land, Texas, 77479, United States
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Charlottesville, Virginia, 22903, 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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Roanoke, Virginia, 24014, United States
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Tacoma, Washington, 98405, United States
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Madison, Wisconsin, 53792, United States
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CABA, 1414, Argentina
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CABA, 1425, Argentina
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CABA, C1113AAE, Argentina
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CABA, C1425, Argentina
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Ciudad Autónoma Buenos Aires, C1430EFA, Argentina
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Ciudad de Buenos Aires, C1015ABO, Argentina
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Rosario, 2000, Argentina
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San Nicolás de los Arroyos, B2900, Argentina
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Camperdown, 2050, Australia
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Darlinghurst, 2010, Australia
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Heidelberg, 3084, Australia
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Melbourne, 3000, Australia
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Nedlands, 6009, Australia
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Waratah, 2298, Australia
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Barretos, 14784-400, Brazil
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Curitiba, 80730-150, Brazil
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Florianópolis, 88034-000, Brazil
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Goiânia, 74000-000, Brazil
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Itajaí, 88301-220, Brazil
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Porto Alegre, 90035-003, Brazil
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Recife, 52010-075, Brazil
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São Paulo, 01246-000, Brazil
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São Paulo, 01317-001, Brazil
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Teresina, 64049-200, Brazil
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Barrie, Ontario, L4M 6M2, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Montreal, Quebec, H2X 0A9, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Québec, Quebec, G1S 4L8, Canada
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Regina, Saskatchewan, S4T 7T1, Canada
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Saskatoon, Saskatchewan, S7N 4H4, Canada
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Anyang, 455000, China
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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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Changsha, 410013, China
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Chengdu, 610000, China
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Chengdu, 610041, China
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Chongqing, 400030, China
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Fuzhou, 350014, China
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Guangzhou, 510060, China
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Guangzhou, 510120, China
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Guangzhou, 510700, China
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Hangzhou, 310009, China
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Hangzhou, 310016, China
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Hangzhou, 310022, China
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Harbin, 150081, China
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Hefei, 230031, China
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ACTIVE_NOT_RECRUITING

Jinan, 250021, China
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Meizhou, 514031, China
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Nanchang, 330009, China
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Nanjing, 2100008, China
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Nanjing, 210009, China
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Nanning, 530021, China
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Shandong, China
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Shanghai, 200025, China
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Shanghai, 200080, China
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Shenyang, 110004, China
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NOT_YET_RECRUITING

Taiyuan, 030000, China
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Tianjin, 300000, China
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Wenzhou, 325000, China
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Wuhan, 430022, China
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Wuhan, 430079, China
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Xi'an, 710061, China
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Xiamen, 361003, China
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Xintai, 54031, China
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Xuzhou, 221009, China
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Zhanjiang, 524003, China
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Zhengzhou, 450008, China
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Zhengzhou, 450052, China
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Lille, 59000, France
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Lyon, 69373, France
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Montpellier, 34298, France
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Paris, 75020, France
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Saint-Herblain, 44805, France
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Toulouse, 31059, France
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Vandœuvre-lès-Nancy, 54511, France
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Villejuif, 94800, France
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Düsseldorf, 40479, Germany
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Essen, 45136, Germany
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Georgsmarienhütte, 49124, Germany
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Hamburg, 20357, Germany
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Hanover, 30625, Germany
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Heidelberg, 69120, Germany
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Heilbronn, 74078, Germany
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Leipzig, 04103, Germany
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RECRUITING

Hong Kong, 999077, Hong Kong
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Hong Kong, Hong Kong
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Shatin, 00000, Hong Kong
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Calicut, 673601, India
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Chennai, 600031, India
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Jaipur, 302004, India
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Kochi, 682027, India
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WITHDRAWN

Kolkata, 700160, India
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NOT_YET_RECRUITING

Kottayam, 686008, India
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RECRUITING

Marg Jaipur, 302004, India
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Mohali, 160055, India
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Mysuru, 570017, India
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Nagpur, 440001, India
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Nashik, 422009, India
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New Delhi, 110075, India
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New Delhi, 11029, India
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Puducherry, 605006, India
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Surat, 395002, India
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Thiruvananthapuram, 695011, India
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Vadodara, 391760, India
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Visakhapatnam, 530053, India
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Bergamo, 24127, Italy
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Empoli, 50053, Italy
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Milan, 20132, Italy
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Milan, 20141, Italy
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Modena, 41124, Italy
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Naples, 80131, Italy
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Padova, 35128, Italy
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Reggio Emilia, 42123, 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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Bunkyō City, 113-8431, Japan
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Bunkyō City, 113-8677, 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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Gifu, 501-1194, Japan
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Hidaka-shi, 350-1298, Japan
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Hiroshima, 730-8518, Japan
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Hiroshima, 734-8551, Japan
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Isehara-shi, 259-1193, Japan
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Kamogawa-shi, 296-8602, Japan
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Kashiwa, 277-8577, Japan
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Kitaadachi-gun, 362-0806, Japan
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Kōtoku, 135-8550, Japan
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Kumamoto, 860-8556, Japan
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Kurume-shi, 830-0011, Japan
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Matsuyama, 791-0280, Japan
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Nagoya, 466-8560, Japan
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Nagoya, 467-8602, 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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Osakasayama-shi, 589-8511, 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, 160-0023, Japan
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Shinjuku-ku, 162-8655, Japan
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Tsu, 514-8507, Japan
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Tsukuba, 305-8577, Japan
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Yokohama, 241-8515, Japan
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CD Mexico, 04980, Mexico
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Guadalajara, 44638, Mexico
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Guadalajara, 44670, Mexico
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Mexico City, 0 3100, Mexico
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Mexico City, 06760, Mexico
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México, 04700, Mexico
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Tuxtla Gutiérrez, 29090, Mexico
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Bacolod, 6100, Philippines
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Cebu City, 6000, Philippines
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City of Muntinlupa, 1780, Philippines
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Manila, 1000, Philippines
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Quezon City, 1112, Philippines
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San Juan City, 1502, Philippines
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Bialystok, 15-027, Poland
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Bydgoszcz, 85-796, Poland
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Gdansk, 80-952, Poland
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Gdynia, 81-519, Poland
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Konin, 62-500, Poland
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Krakow, 31-115, Poland
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Krakow, 31-501, Poland
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Legnica, 59-220, Poland
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Lodz, 90-302, Poland
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Lublin, 20-090, Poland
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Przemyśl, 37-700, Poland
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Warsaw, 02-781, Poland
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Wroclaw, 53-413, Poland
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Singapore, 119228, Singapore
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Singapore, 169610, Singapore
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Singapore, 217562, Singapore
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Singapore, 308433, Singapore
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Cape Town, 7570, South Africa
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Johannesburg, 2013, South Africa
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Johannesburg, 2193, South Africa
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Johannesburg, 2196, South Africa
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Paarl, 7646, South Africa
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ACTIVE_NOT_RECRUITING

Pretoria, 0081, South Africa
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Pretoria, 0081, South Africa
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COMPLETED

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, 13620, 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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Seoul, 06591, South Korea
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Barcelona, 08028, Spain
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Barcelona, 8035, Spain
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Granada, 18016, Spain
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Hospitalet deLlobregat, 08907, Spain
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Madrid, 28007, Spain
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Madrid, 28034, Spain
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Pamplona, 31008, Spain
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Santander, 39008, Spain
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Hsinchu, 300, Taiwan
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Kaohsiung City, 80756, Taiwan
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Taichung, 40447, Taiwan
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Tainan, 704, Taiwan
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Taipei, 100, Taiwan
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Taipei, 10449, Taiwan
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Taipei, 11259, Taiwan
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Taipei, 112, Taiwan
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Taoyuan, 333, Taiwan
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Bangkok, 10210, Thailand
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Bangkok, 10330, Thailand
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Bangkok, 10400, Thailand
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Bangkok, 10700, Thailand
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Chiang Mai, 50200, Thailand
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Dusit, 10300, Thailand
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Khon Kaen, 40002, Thailand
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Songkhla, 90110, Thailand
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Ankara, 06520, Turkey (Türkiye)
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Ankara, 6200, Turkey (Türkiye)
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Besevler Ankara, Turkey (Türkiye)
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Istanbul, 34010, Turkey (Türkiye)
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Izmir, 35575, Turkey (Türkiye)
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Küçükçekmece, 34295, Turkey (Türkiye)
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Samsun, 55200, Turkey (Türkiye)
Research Site
RECRUITING

Cardiff, CF14 2TL, United Kingdom
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RECRUITING

Chelsea, SW3 6JJ, United Kingdom
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RECRUITING

Leicester, Le5 4PW, United Kingdom
Research Site
TERMINATED

Liverpool, L7 8YA, United Kingdom
Research Site
RECRUITING

London, EC1A 7BE, United Kingdom
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WITHDRAWN

London, SW17 0QT, United Kingdom
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SUSPENDED

Oxford, OX3 7LE, United Kingdom
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SUSPENDED

Surrey, GU2 7XX, United Kingdom
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RECRUITING

Sutton, SM2 5PT, United Kingdom
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RECRUITING

Taunton, TA1 5DA, United Kingdom
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RECRUITING

Da Nang, 550000, Vietnam
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RECRUITING

Hanoi, 100000, Vietnam
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RECRUITING

Ho Chi Minh City, 700000, Vietnam
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RECRUITING

Hồ Chí Minh, 700000, Vietnam
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RECRUITING

Huế, 530000, Vietnam
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RECRUITING

Viet Tri, 35000, Vietnam
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RECRUITING

Vinh, 460000, Vietnam

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