A Study of DB-1303/BNT323 vs Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Metastatic Breast Cancer (DYNASTY-Breast02)

Part of paid clinical trials in Tucson, Arizona.

Sponsor
DualityBio Inc.
Study ID
NCT06018337
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • DB-1303/BNT323 — DRUG
    IV
  • Capecitabine — DRUG
    Oral
  • Paclitaxel — DRUG
    IV
  • Nab-paclitaxel — DRUG
    IV

Study Details

The goal of this clinical trial is to assess the efficacy of DB-1303/BNT323 compared with investigator's choice chemotherapy in terms of progression-free survival (PFS) by blinded independent central review (BICR) in the HR+, HER2-low (immunohistochemistry \[IHC\]2+/in situ hybridization \[ISH\]- and IHC 1+) population.

Key Dates

Start date
Jan 18, 2024
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Aug 31, 2028

Study Design

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

Arms

  • Experimental: DB-1303/BNT323
    Enrolled Subjects will be randomized to receive a 8 mg/kg IV dose of DB-1303/BNT323 on Day 1 of each cycle Q3W
  • Active Comparator: investigator's choice single agent chemotherapy
    Enrolled Subjects will be randomized to receive investigator's choice single agent chemotherapy (capecitabine:1000 or 1250 mg/m2, Oral, Twice daily orally for 2 weeks followed by a 1-week rest period in 3-week cycles; paclitaxel：80 mg/m2， IV, Every week (QW) in 3-week cycles; or nab-paclitaxel: 100 mg/m2, IV, Every week (QW) for 3 weeks followed by a one-week rest period in 4-week cycles) until RECIST 1.1 defined disease progression (PD), unless there is unacceptable toxicity, withdrawal of consent, or another criterion for discontinuation is met.

Primary Outcome Measure

Progression-free survival (PFS) in the HR+, HER2-low population [ Time Frame: Up to approximately 51 months ]

Locations (45)

FacilityCityStateZIPSite coordinators
Research Site 1141-0TucsonArizona85704-
Research Site 1114-0FullertonCalifornia92835-
Research Site 1107-0Los AngelesCalifornia90095-
Research Site 1118-0OrangeCalifornia92868-3201-
Research Site 1143-0SacramentoCalifornia95814-
Research Site 1132-0Santa BarbaraCalifornia93105-
Research Site 1137-0AuroraColorado80045-
Research Site 1129-0Lone TreeColorado80124-
Research Site 1154-0JacksonvilleFlorida32256-
Research Site 1145-0MiamiFlorida33136-
Research Site 1150-0Orange CityFlorida32763-
Research Site 1125-0Palm BayFlorida32909-
Research Site 1155-0AthensGeorgia30607-
Research Site 1110-0SavannahGeorgia31405-
Research Site 1147-0ChicagoIllinois60611-
Research Site 1124-0Chicago RidgeIllinois60415-
Research Site 1152-0Fort WayneIndiana46804-
Research Site 1106-0MerriamKansas66204-
Research Site 1104-0LouisvilleKentucky40202-
Research Site 1122-0Silver SpringMaryland20904-
Research Site 8639-0Silver SpringMaryland20904-
Research Site 1109-0Kansas CityMissouri64111-
Research Site 1158-0CamdenNew Jersey08103-
Research Site 1111-0Florham ParkNew Jersey07932-
Research Site 1157-0Sante FeNew Mexico87505-
Research Site 1148-0Staten IslandNew York10314-
Research Site 1105-0WestburyNew York11590-
Research Site 1144-0Chapel HilNorth Carolina27599-
Research Site 1138-0AkronOhio44305-
Research Site 1160-0CincinnatiOhio45220-
Research Site 1133-0EugeneOregon97401-8122-
Research Site 1126-0TigardOregon97223-
Research Site 1134-0BroomallPennsylvania19008-
Research Site 1123-0HorshamPennsylvania19044-
Research Site 1149-0KnoxvilleTennessee37909-
Research Site 1102-0NashvilleTennessee37203-
Research Site 1159-0NashvilleTennessee37203-
Research Site 1101-0DallasTexas75246-
Research Site 1116-0DenisonTexas75020-
Research Site 1115-0HoustonTexas77030-
Research Site 1117-0San AntonioTexas78240-
Research Site 1130-0Salt Lake CityUtah84124-
Research Site 1108-0FairfaxVirginia22031-
Research Site 1131-0FairfaxVirginia22031-
Research Site 1127-0RoanakeVirginia24014-

Find similar trials in Tucson, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
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