A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain

Study acronym: CAPItana
StatusActive, Not Recruiting
PhasePhase 3
Started

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Record History

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  1. Primary and study completion moved earlier from Dec 31, 2027 to Nov 30, 2027
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 3 of 11 entries
    • Site details revised at 1 of 17 sites
  2. 2 versions Re-verified since Apr 7, 2026, no change to tracked fieldsv15-v16
  3. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 100 to confirmed 101
    • Study sites: 18 to 17
    v14
  4. 4 versions Re-verified since Sep 19, 2025, no change to tracked fieldsv10-v13
  5. Site details revised at 1 of 18 sitesv9
Show 7 earlier versionsHide 7 earlier versions
  1. Eligibility criteria expanded, about 37 wordsv8
  2. Site details revised at 1 of 18 sitesv7
  3. Re-verified, no change to tracked fieldsv6
  4. Primary and study completion dates: Jan 31, 2028 to Dec 31, 2027
    • Site details revised at 13 of 18 sites
    v5
  5. Re-verified, no change to tracked fieldsv4
  6. Study sites: 2 to 18
    • Start date: Jan 8, 2025 to Jan 7, 2025
    v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    • Primary and study completion dates: Dec 31, 2027 to Jan 31, 2028
    • Start date changed from estimate of Dec 31, 2024 to Jan 8, 2025
    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.
AstraZeneca
729 trials monitored
See 62 trials at risk
Breast Cancer
5,455 trials monitored
See 306 trials at risk
The purpose of this study is to evaluate the effectiveness and safety of capivasertib + fulvestrant treatment administration in patients with locally advanced (inoperable) or metastatic HR+ / HER2- breast cancer with PIK3CA/AKT1/PTEN-altered following recurrence or progression on or after endocrine therapy and CDK4/6 inhibitor.
Trial Details
NCT Number NCT06764186
Lead Sponsor AstraZeneca
Collaborators: Apices Soluciones S.L., SOLTI Breast Cancer Research Group
Conditions
(from sponsor)		 Locally Advanced or Metastatic Breast Cancer
Related terms Breast Neoplasms
Enrollment 101 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov