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BettER: Biomarker Driven Early Therapeutic Selection in Patients With HR+ HER2- Metastatic or Unresectable Breast Cancer

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 12 months later Sep 30, 2034 → Sep 30, 2035
Primary endpoint added 3 → 4 primary endpoints
See other at-risk trials from Washington University School of Medicine

Record History

  1. Primary and study completion pushed from Sep 30, 2034 to Sep 30, 2035 Primary endpoint(s) modified · Enrollment increased: 65 → 145 participants · Interventions modified · 3 more Show 6 more changesShow less
    • Primary endpoint(s) modified
    • Enrollment increased: 65 → 145 participants
    • Interventions modified
    • Trial arms changed: 3 → 8
    • Eligibility criteria expanded, about 148 words
    • Secondary endpoints: 9 to 12
  2. 3 versions Re-verified since Oct 8, 2024, no change to tracked fieldsv11-v13
  3. Trial status: Not Yet Recruiting to Recruiting Primary and study completion dates: Oct 31, 2034 to Sep 30, 2034 · Start date: Oct 31, 2024 to Sep 25, 2024 · Site details revisedv10 Show 3 more changesShow less
    • Primary and study completion dates: Oct 31, 2034 to Sep 30, 2034
    • Start date: Oct 31, 2024 to Sep 25, 2024
    • Site details revised
  4. Start date: Aug 31, 2024 to Oct 31, 2024 Primary and study completion dates: Aug 31, 2034 to Oct 31, 2034v9 Show 1 more changeShow less
    • Primary and study completion dates: Aug 31, 2034 to Oct 31, 2034
  5. Site contact updatedv8
Show 6 earlier versionsHide 6 earlier versions
  1. Start date: Jun 30, 2024 to Aug 31, 2024 Primary and study completion dates: Jun 30, 2034 to Aug 31, 2034v7 Show 1 more changeShow less
    • Primary and study completion dates: Jun 30, 2034 to Aug 31, 2034
  2. Start date: Apr 30, 2024 to Jun 30, 2024 Primary and study completion dates: Apr 30, 2034 to Jun 30, 2034v6 Show 1 more changeShow less
    • Primary and study completion dates: Apr 30, 2034 to Jun 30, 2034
  3. Start date: Feb 28, 2024 to Apr 30, 2024 Primary and study completion dates: Feb 28, 2034 to Apr 30, 2034v5 Show 1 more changeShow less
    • Primary and study completion dates: Feb 28, 2034 to Apr 30, 2034
  4. Start date: Dec 31, 2023 to Feb 28, 2024 Primary and study completion dates: Dec 31, 2033 to Feb 28, 2034v4 Show 1 more changeShow less
    • Primary and study completion dates: Dec 31, 2033 to Feb 28, 2034
  5. Start date: Nov 30, 2023 to Dec 31, 2023 Primary and study completion dates: Nov 30, 2033 to Dec 31, 2033 · Site contact updatedv3 Show 2 more changesShow less
    • Primary and study completion dates: Nov 30, 2033 to Dec 31, 2033
    • Site contact updated
  6. Start date: Sep 30, 2023 to Nov 30, 2023 Primary and study completion dates: Sep 30, 2033 to Nov 30, 2033v2 Show 1 more changeShow less
    • Primary and study completion dates: Sep 30, 2033 to Nov 30, 2033
  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 is a prospective study to assess the impact of biomarker driven, early therapeutic switching and delayed imaging with the incorporation of DiviTum® serum TK1 activity ("DiviTum® TKa") in patients with hormone receptor (HR) positive, HER-2 negative metastatic or unresectable breast cancer receiving first-line or second-line treatment.
Trial Details
NCT Number NCT05977036
Lead Sponsor Washington University School of Medicine
Collaborators: Biovica
Conditions Metastatic Breast Cancer, Unresectable Breast Cancer
Enrollment 145 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov