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)

Status: Recruiting
Location: See all (308) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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. If no such sample is available, 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.

Locations
United States
Alabama
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Daphne
Arkansas
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Springdale
California
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Duarte
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Glendale
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Sacramento
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Santa Rosa
Colorado
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Aurora
Connecticut
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Florida
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Jacksonville
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Miami
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Palm Bay
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Plantation
Georgia
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Atlanta
Hawaii
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Honolulu
Iowa
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Des Moines
Illinois
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Chicago
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Decatur
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Elmhurst
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Naperville
Indiana
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New Albany
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Lexington
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Providence
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Houston
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Mckinney
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Sugar Land
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France
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Lyon
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Toulouse
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Germany
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Chennai
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City Of Muntinlupa
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Poland
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Gdynia
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Konin
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Lodz
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Lublin
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Przemyśl
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Warsaw
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Wroclaw
Republic of Korea
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Singapore
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South Africa
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Cape Town
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Johannesburg
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Paarl
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Pretoria
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Granada
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Hospitalet Dellobregat
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Madrid
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Pamplona
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Santander
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Hsinchu
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Kaohsiung City
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Taichung
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Tainan City
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Taipei
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Taipei
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Taipei
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Taoyuan District
Thailand
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Bangkok
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Bangkok
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Bangkok
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Chiang Mai
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Dusit
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Khon Kaen
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Songkhla
Turkey
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Ankara
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Ankara
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Besevler Ankara
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Izmir
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Küçükçekmece
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Samsun
United Kingdom
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Cardiff
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Chelsea
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Leicester
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Liverpool
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London
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London
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Oxford
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Surrey
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Sutton
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Taunton
Viet Nam
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Da Nang
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Hanoi
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Hồ Chí Minh
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Ho Chi Minh City
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Huế
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Việt Trì
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Vinh
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Backup
AstraZeneca Breast Cancer Study Locator Service
az-bcsl@careboxhealth.com
+1-877-400-4656
Time Frame
Start Date: 2023-11-23
Estimated Completion Date: 2029-04-30
Participants
Target number of participants: 625
Treatments
Experimental: Dato-DXd + durvalumab
Arm 1: Dato-DXd + durvalumab
Active_comparator: Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab
Arm 2: Investigator's Choice of Chemotherapy (ICC) in combination with pembrolizumab (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin)
Experimental: Dato-DXd
Arm 3: Dato-DXd
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca
Collaborators: Daiichi Sankyo

This content was sourced from clinicaltrials.gov