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Safety and Preliminary Effectiveness of BNT327, an Investigational Therapy for Breast Cancer, When Given in Combination With Chemotherapy

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv19
  2. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 100 to confirmed 83 · Study sites: 62 to 31 · Collaborators expanded, about 2 wordsv18 Show 3 more changesShow less
    • Enrollment target: estimated 100 to confirmed 83
    • Study sites: 62 to 31
    • Collaborators expanded, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 2 of 62 sitesv17
  4. Site details revised at 7 of 62 sitesv16
  5. Site details revised at 2 of 62 sitesv15
Show 13 earlier versionsHide 13 earlier versions
  1. Site details revised at 6 of 62 sitesv14
  2. Primary completion date: Nov 2027 to Aug 2028 Enrollment target: 70 to 100 · Completion date: Sep 2028 to Jun 2029 · Eligibility criteria expanded, about 7 words · 3 morev13 Show 6 more changesShow less
    • Enrollment target: 70 to 100
    • Completion date: Sep 2028 to Jun 2029
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 4 of 11 entries
    • Study description expanded, about 16 words
    • Site details revised at 29 of 62 sites

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 38 of 62 sitesv12
  4. Study sites: 67 to 62v11
  5. Primary completion date: Mar 2025 to Nov 2027 Study sites: 64 to 67 · Completion date: Jan 2027 to Sep 2028v10 Show 2 more changesShow less
    • Study sites: 64 to 67
    • Completion date: Jan 2027 to Sep 2028
  6. Study sites: 47 to 64v9
  7. Study sites: 36 to 47v8
  8. Study sites: 24 to 36v7
  9. Primary endpoints revised (5) Enrollment target: 60 to 70 · Study sites: 20 to 24 · Interventions: Alkylating agent (Drug), Antimetabolite (Drug), BNT327 Dose Level 1 (DL1) (Drug), BNT327 Dose Level 1 (DL2) (Drug), Taxane A (Drug), Taxane… to BNT327 Dose Level 1 (DL1) (Drug), BNT327 Dose Level 1 (DL2) (Drug), BNT327 Equivalent Q3W Dose (Drug), BNT327 Optimized Dose (Drug)… · 4 morev6 Show 7 more changesShow less
    • Enrollment target: 60 to 70
    • Study sites: 20 to 24
    • Interventions: Alkylating agent (Drug), Antimetabolite (Drug), BNT327 Dose Level 1 (DL1) (Drug), BNT327 Dose Level 1 (DL2) (Drug), Taxane A (Drug), Taxane… to BNT327 Dose Level 1 (DL1) (Drug), BNT327 Dose Level 1 (DL2) (Drug), BNT327 Equivalent Q3W Dose (Drug), BNT327 Optimized Dose (Drug)…
    • Eligibility criteria shortened, about 52 words
    • Secondary endpoints: 13 to 11
    • Study description expanded, about 123 words
    • Study arms: 4 to 5

    See this version in full on ClinicalTrials.gov ↗

  10. Study sites: 17 to 20v5
  11. Study sites: 15 to 17 Start date changed from estimate of Aug 2024 to Aug 26, 2024v4 Show 1 more changeShow less
    • Start date changed from estimate of Aug 2024 to Aug 26, 2024
  12. Trial status: Not Yet Recruiting to Recruiting Study sites: 3 to 15v3 Show 1 more changeShow less
    • Study sites: 3 to 15
  13. Start date: Jun 2024 to Aug 2024 Study sites: 0 to 3 · Primary completion date: Feb 2025 to Mar 2025 · Completion date: Apr 2026 to Jan 2027v2 Show 3 more changesShow less
    • Study sites: 0 to 3
    • Primary completion date: Feb 2025 to Mar 2025
    • Completion date: Apr 2026 to Jan 2027
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
This study is a Phase II, multi-site, randomized, open-label clinical study to evaluate the safety, efficacy, and pharmacokinetics (PK) of BNT327 at two dose levels in combination with chemotherapeutic agents in the first- and second-line treatment of participants with locally advanced/metastatic triple-negative breast cancer (mTNBC).
Trial Details
NCT Number NCT06449222
Lead Sponsor BioNTech SE
Collaborators: Bristol-Myers Squibb
Conditions Locally Advanced Breast Cancer, Triple Negative Breast Cancer, Metastatic Triple Negative Breast Cancers
Enrollment 83 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov