Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib

Study acronym: SAFIR 03
StatusTerminated
PhasePhase 2
SponsorUNICANCER
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. Trial terminated Sponsor's reason: poor accrual Show 7 more changesShow less
    • Final enrollment: 4 participants — 2% of the 162 planned
    • Primary completion date changed from estimate of Jul 2028 to Mar 30, 2025
    • Study completion date changed from estimate of Jun 2030 to Jan 20, 2026
    • Eligibility criteria expanded, about 80 words
    • Secondary endpoints: details revised at 1 of 9 entries
    • Study description revised
    • Site details revised at 4 of 44 sites
  2. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 44 of 44 sites
    v8
  3. Study sites: 43 to 44v7
  4. Study sites: 42 to 43v6
  5. Re-verified, no change to tracked fieldsv5
Show 3 earlier versionsHide 3 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 42
    • Start date changed from estimate of Nov 2023 to Oct 19, 2023
    v4
  2. Start date: Jun 2023 to Nov 2023v3
  3. Start date: Feb 2023 to Jun 2023v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
UNICANCER
98 trials monitored
See 6 trials at risk
Breast Cancer
5,455 trials monitored
See 306 trials at risk
After an initial screening phase (SAFIR 03 - SCREENING) to identify patients with blood circulating mutated-PIK3CA tumours persistent, patients will be enrolled in the treatment phase of SAFIR 03 (SAFIR 03 - ARRIBA) that was designed as a randomised, open-label, multicentre, phase II study, for comparison of alpelisib to ribociclib in combination with fulvestrant (as the continuation of the CDK4/6 inhibitor-fulvestrant strategy) in terms of progression-free survival (PFS).
Trial Details
NCT Number NCT05625087
Lead Sponsor UNICANCER
Collaborators: Novartis, Breast Cancer Research Foundation
Conditions
(from sponsor)		 Breast Cancer Stage IV
Related terms Breast Neoplasms
Enrollment 4 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov