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

Part of paid clinical trials in Daphne, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06103864
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dato-DXd — DRUG
    Provided in 100mg vials. IV infusion. Experimental drug.
  • Durvalumab — DRUG
    Provided in 500mg vials. IV infusion. Experimental drug.
  • Paclitaxel — DRUG
    IV infusion. Active comparator.
  • Nab-paclitaxel — DRUG
    IV infusion. Active comparator.
  • Gemcitabine — DRUG
    IV infusion. Active comparator.
  • Carboplatin — DRUG
    IV infusion. Active comparator.
  • Pembrolizumab — DRUG
    IV infusion. Active comparator.

Study Details

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.

Key Dates

Start date
Nov 23, 2023
Status verified
Apr 2026
Primary completion
Jul 28, 2027
Completion
Sep 30, 2030

Study Design

Enrollment
625 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: From randomisation until progression per RECIST 1.1 as assessed by BICR, or death due to any cause (anticipated to be up to 33 months). ]

Central Contacts

Locations (64)

FacilityCityStateZIPSite coordinators
Research SiteDaphneAlabama36526-
Research SiteSpringdaleArkansas72762-
Research SiteDuarteCalifornia91010-
Research SiteGlendaleCalifornia91204-
Research SiteSacramentoCalifornia95817-
Research SiteSanta RosaCalifornia95403-
Research SiteAuroraColorado80012-
Research SiteNew HavenConnecticut06510-
Research SiteJacksonvilleFlorida32256-
Research SiteMiamiFlorida33176-
Research SitePalm BayFlorida32909-
Research SitePlantationFlorida33324-
Research SiteAtlantaGeorgia30318-
Research SiteHonoluluHawaii96819-
Research SiteChicagoIllinois60637-
Research SiteDecaturIllinois62526-
Research SiteElmhurstIllinois60126-
Research SiteNapervilleIllinois60540-
Research SiteNew AlbanyIndiana47150-
Research SiteDes MoinesIowa50309-
Research SiteLexingtonKentucky40503-
Research SiteLouisvilleKentucky40202-
Research SiteLouisvilleKentucky40207-
Research SiteBaton RougeLouisiana70808-
Research SiteBaton RougeLouisiana70809-
Research SiteBaltimoreMaryland21215-
Research SiteColumbiaMaryland21044-
Research SiteBostonMassachusetts02111-
Research SiteWorcesterMassachusetts01655-
Research SiteDetroitMichigan48201-
Research SiteGrand RapidsMichigan49503-
Research SiteSaint PaulMinnesota55109-
Research SiteHattiesburgMississippi39401-
Research SiteSt LouisMissouri63129-
Research SiteAlbuquerqueNew Mexico87109-
Research SiteAlbanyNew York12206-
Research SiteNew YorkNew York10065-
Research SiteStony BrookNew York11794-7263-
Research SiteCincinnatiOhio45219-
Research SiteCincinnatiOhio45245-
Research SiteClevelandOhio44195-
Research SiteYorkPennsylvania17403-
Research SiteProvidenceRhode Island02903-
Research SiteChattanoogaTennessee37404-
Research SiteNashvilleTennessee37203-
Research SiteDallasTexas75230-
Research SiteDallasTexas75246-
Research SiteDallasTexas75246-
Research SiteEl PasoTexas79902-
Research SiteFlower MoundTexas75028-
Research SiteFort WorthTexas76104-
Research SiteHoustonTexas77054-
Research SiteHoustonTexas77090-
Research SiteHoustonTexas77098-
Research SiteKingwoodTexas77339-
Research SiteMcKinneyTexas75071-
Research SiteSugar LandTexas77479-
Research SiteCharlottesvilleVirginia22903-
Research SiteFairfaxVirginia22031-
Research SiteMidlothianVirginia23114-
Research SiteNorfolkVirginia23502-
Research SiteRoanokeVirginia24014-
Research SiteTacomaWashington98405-
Research SiteMadisonWisconsin53792-

Find similar trials in Daphne, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Research Site· Daphne, ALResearch Site· Springdale, ARResearch Site· Duarte, CAResearch Site· Glendale, CAResearch Site· Sacramento, CAResearch Site· Santa Rosa, CA

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