A Phase-3, Open-Label, Randomized Study of Dato-DXd Versus Investigator's Choice of Chemotherapy (ICC) in Participants With Inoperable or Metastatic HR-Positive, HER2-Negative Breast Cancer Who Have Been Treated With One or Two Prior Lines of Systemic Chemotherapy (TROPION-Breast01)

Part of paid clinical trials in Duarte, California.

Sponsor
AstraZeneca
Study ID
NCT05104866
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Dato-DXd — DRUG
    Experimental drug. Provided in 100mg vials. IV infusion.
  • Capecitabine — DRUG
    Tablet. Oral route of administration. Active comparator
  • Gemcitabine — DRUG
    IV Infusion. Active comparator
  • Eribulin — DRUG
    IV Infusion. Active comparator
  • Vinorelbine — DRUG
    IV Infusion. Active comparator

Study Details

The study will evaluate the safety and efficacy of datopotamab deruxtecan (also known as Dato-DXd, DS-1062a), when compared with Investigator's choice of standard of care single-agent chemotherapy (eribulin, capecitabine, vinorelbine, or gemcitabine) in participants with inoperable or metastatic HR-positive, HER2- negative breast cancer who have been treated with one or two prior lines of systemic chemotherapy.

Key Dates

Start date
Oct 18, 2021
Status verified
May 2026
Primary completion
Jul 24, 2024
Completion
Jul 31, 2026

Study Design

Enrollment
732 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dato-DXd
    Arm 1: Dato-DXd
  • Active Comparator: Investigators Choice of Chemotherapy (ICC)
    Arm 2: ICC Capecitabine Gemcitabine Eribulin mesylate Vinorelbine

Primary Outcome Measure

Progression-Free Survival [ Time Frame: On-study tumor assessments occur every 6 weeks then every 9 weeks until disease progression, death or withdrawal of consent assessed up to data cut-off (17Jul2023) to a maximum of approximately 21 months ]

Locations (14)

FacilityCityStateZIPSite coordinators
Research SiteDuarteCalifornia91010-
Research SiteLos AngelesCalifornia90095-
Research SitePalo AltoCalifornia94305-5826-
Research SiteSan FranciscoCalifornia94143-
Research SiteJacksonvilleFlorida32207-
Research SiteAtlantaGeorgia30322-
Research SiteBostonMassachusetts02114-
Research SiteBostonMassachusetts02215-
Research SiteGrand RapidsMichigan49503-
Research SiteNew YorkNew York10065-
Research SiteClevelandOhio44119-
Research SitePortlandOregon97239-
Research SiteNashvilleTennessee37203-
Research SiteRichmondVirginia23219-

Find similar trials in Duarte, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Research Site· Duarte, CAResearch Site· Los Angeles, CAResearch Site· Palo Alto, CAResearch Site· San Francisco, CAResearch Site· Jacksonville, FLResearch Site· Atlanta, GA

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