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RECRUITING

NCT06103864

PHASE3

A Phase III Study of Dato-DXd With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)

Sponsor: AstraZeneca

View on ClinicalTrials.gov

Summary

This is a Phase III, randomised, open-label, 3-arm, multicentre, international study assessing the efficacy and safety of Dato-DXd with or without durvalumab compared with investigator's choice chemotherapy in combination with pembrolizumab in participants with PD-L1 positive locally recurrent inoperable or metastatic TNBC.

Official title: A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

625

Start Date

2023-11-23

Completion Date

2030-09-30

Last Updated

2026-09-25

Healthy Volunteers

No

Conditions

Interventions

DRUG

Dato-DXd

Provided in 100mg vials. IV infusion. Experimental drug.

DRUG

Durvalumab

Provided in 500mg vials. IV infusion. Experimental drug.

DRUG

Paclitaxel

IV infusion. Active comparator.

DRUG

Nab-paclitaxel

IV infusion. Active comparator.

DRUG

Gemcitabine

IV infusion. Active comparator.

DRUG

Carboplatin

IV infusion. Active comparator.

DRUG

Pembrolizumab

IV infusion. Active comparator.

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.

Locations (318)

Research Site

Daphne, Alabama, United States

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Springdale, Arkansas, United States

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Duarte, California, United States

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Fountain Valley, California, United States

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Glendale, California, United States

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Sacramento, California, United States

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Santa Rosa, California, United States

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Aurora, Colorado, United States

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Denver, Colorado, United States

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New Haven, Connecticut, United States

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Altamonte Springs, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Palm Bay, Florida, United States

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Plantation, Florida, United States

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Atlanta, Georgia, United States

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Honolulu, Hawaii, United States

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Chicago, Illinois, United States

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Decatur, Illinois, United States

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Elmhurst, Illinois, United States

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Naperville, Illinois, United States

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New Albany, Indiana, United States

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Des Moines, Iowa, United States

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Lexington, Kentucky, United States

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Louisville, Kentucky, United States

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Louisville, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Baton Rouge, Louisiana, United States

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Baltimore, Maryland, United States

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Columbia, Maryland, United States

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Boston, Massachusetts, United States

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Worcester, Massachusetts, United States

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Detroit, Michigan, United States

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Grand Rapids, Michigan, United States

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Saint Paul, Minnesota, United States

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Hattiesburg, Mississippi, United States

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St Louis, Missouri, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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New York, New York, United States

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Stony Brook, New York, United States

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Cincinnati, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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York, Pennsylvania, United States

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Providence, Rhode Island, United States

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Chattanooga, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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El Paso, Texas, United States

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Flower Mound, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Kingwood, Texas, United States

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McKinney, Texas, United States

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Sugar Land, Texas, United States

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Charlottesville, Virginia, United States

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Fairfax, Virginia, United States

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Midlothian, Virginia, United States

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Norfolk, Virginia, United States

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Roanoke, Virginia, United States

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Tacoma, Washington, United States

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Madison, Wisconsin, United States

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CABA, Argentina

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CABA, Argentina

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CABA, Argentina

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CABA, Argentina

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Ciudad Autónoma Buenos Aires, Argentina

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Ciudad de Buenos Aires, Argentina

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Rosario, Argentina

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San Nicolás de los Arroyos, Argentina

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Camperdown, Australia

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Darlinghurst, Australia

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Heidelberg, Australia

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Melbourne, Australia

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Nedlands, Australia

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Waratah, Australia

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Barretos, Brazil

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Curitiba, Brazil

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Florianópolis, Brazil

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Goiânia, Brazil

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Itajaí, Brazil

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Porto Alegre, Brazil

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Recife, Brazil

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São Paulo, Brazil

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São Paulo, Brazil

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Teresina, Brazil

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Barrie, Ontario, Canada

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Hamilton, Ontario, Canada

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Toronto, Ontario, Canada

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Greenfield Park, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Regina, Saskatchewan, Canada

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Saskatoon, Saskatchewan, Canada

And 218 more locations on ClinicalTrials.gov