Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
AstraZeneca
Study ID
NCT04494425
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Advanced or Metastatic Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 105 Years
Healthy Volunteers
Not accepted

Interventions

  • Trastuzumab deruxtecan — DRUG
    Trastuzumab deruxtecan by intravenous infusion
  • Capecitabine — DRUG
    Investigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally.
  • Paclitaxel — DRUG
    Investigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion.
  • Nab-Paclitaxel — DRUG
    Investigator's choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion

Study Details

This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.

Key Dates

Start date
Jul 24, 2020
Status verified
Feb 2026
Primary completion
Mar 18, 2024
Completion
Jun 19, 2026

Study Design

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

Arms

  • Experimental: Trastuzumab deruxtecan
    Trastuzumab deruxtecan (T-DXd; DS-8201a) arm
  • Active Comparator: Standard of Care
    Investigator's choice standard of care chemotherapy (capecitabine, paclitaxel, nab-paclitaxel) arm

Primary Outcome Measure

Progression-Free Survival (PFS) Assessed by Blinded Independent Central Review (BICR) in the Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2 (HER2)-Low Population [ Time Frame: Response evaluations performed at screening, every 6 weeks (q6w) ± 1 week from randomization for 48 weeks, and then every 9 weeks (q9w) ± 1 week, starting at Week 48 until PD, up to PCD of 18 March 2024 (maximum of approximately 43.85 months) ]

Locations (27)

FacilityCityStateZIPSite coordinators
Research SiteScottsdaleArizona85259-
Research SiteSpringdaleArkansas72762-
Research SiteDuarteCalifornia91010-
Research SiteLos AngelesCalifornia90017-
Research SiteAuroraColorado80045-
Research SiteLakewoodColorado80228-
Research SiteWashington D.C.District of Columbia20016-
Research SiteJacksonvilleFlorida32224-
Research SiteKansas CityKansas66160-
Research SiteLouisvilleKentucky40202-
Research SiteBethesdaMaryland20817-
Research SiteBostonMassachusetts02114-
Research SiteDetroitMichigan48202-
Research SiteRochesterMinnesota55905-
Research SiteSt LouisMissouri63110-
Research SiteSummitNew Jersey07901-
Research SiteWestburyNew York11590-
Research SiteColumbusOhio43210-
Research SitePittsburghPennsylvania15212-
Research SiteNashvilleTennessee37232-
Research SiteAustinTexas78731-
Research SiteDallasTexas75246-
Research SiteHoustonTexas77030-
Research SiteHoustonTexas77090-
Research SiteNorfolkVirginia23502-
Research SiteSeattleWashington98104-
Research SiteMadisonWisconsin53792-5666-

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