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

StatusActive, Not Recruiting
PhasePhase 3
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date changed from estimate of Jun 2026 to Aug 12, 2026 Show 5 more changesShow less
    • Interventions: Capecitabine (Drug), DB-1303/BNT323 (Drug), Nab-paclitaxel (Drug), Paclitaxel (Drug) to Capecitabine (Drug), DB-1303/BNT323 (Drug), Nab-paclitaxel (Drug), Paclitaxel (Drug)
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 4 of 10 entries
    • Study description revised
    • Site details revised at 2 of 258 sites
  2. Trial sites reduced: 261 → 258 locations
    • Primary completion pushed from May 2026 to Jun 2026
    • Study completion pushed from Jul 2028 to Aug 2028
    v13
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 532 to confirmed 541
    • Study sites: 253 to 261
    v12
  4. Study sites: 185 to 253v11
  5. Primary completion date: Dec 2025 to May 2026
    • Study completion date: May 2028 to Jul 2028
    v10
Show 8 earlier versionsHide 8 earlier versions
  1. Site details revised at 3 of 185 sitesv9
  2. Study sites: 127 to 185
    • Eligibility criteria expanded, about 461 words
    • Secondary endpoints: details revised at 2 of 10 entries
    • Study description revised
    v8
  3. Study sites: 45 to 127v7
  4. Re-verified, no change to tracked fieldsv6
  5. Study sites: 4 to 45v5
  6. Trial status: Not Yet Recruiting to Recruitingv4 Show 10 more changesShow less
    • Study sites: 1 to 4
    • Primary completion date: Aug 2025 to Dec 2025
    • Study completion date: Jun 2027 to May 2028
    • Start date changed from estimate of Jan 2024 to Jan 18, 2024
    • Interventions: Capecitabine (Drug), DB-1303 (Drug), Nab-paclitaxel (Drug), Paclitaxel (Drug) to Capecitabine (Drug), DB-1303/BNT323 (Drug), Nab-paclitaxel (Drug), Paclitaxel (Drug)
    • Eligibility criteria expanded, about 38 words
    • Secondary endpoints: 5 to 10
    • Study description expanded, about 12 words
    • Collaborators expanded, about 2 words
    • Study title expanded, about 5 words
  7. Start date: Nov 2023 to Jan 2024v3
  8. Primary endpoint revised
    • Enrollment target: 466 to 532
    • Secondary endpoints: 6 to 5
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
DualityBio Inc.
11 trials monitored
See 1 trial at risk
Breast Cancer
5,455 trials monitored
See 306 trials at risk
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.
Trial Details
NCT Number NCT06018337
Lead Sponsor DualityBio Inc.
Collaborators: BioNTech SE
Conditions
(from sponsor)		 Metastatic Breast Cancer
Related terms Breast Neoplasms
Enrollment 541 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov