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Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 2 to 3 Eligibility criteria expanded, about 15 words · Secondary endpoints: details revised at 1 of 3 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 15 words
    • Secondary endpoints: details revised at 1 of 3 entries
  2. Re-verified, no change to tracked fieldsv16
  3. Site details revised at 1 of 2 sitesv15
  4. Site details revised at 1 of 2 sitesv14
  5. Interventions: Abemaciclib (Drug), Anastrozole (Drug), Biospecimen Collection (Procedure), Computed Tomography (Procedure), Diagnostic Imaging… to Abemaciclib (Drug), Anastrozole (Drug), Biospecimen Collection (Procedure), Computed Tomography (Procedure), Diagnostic Imaging Testing… Eligibility criteria expanded, about 29 wordsv13 Show 1 more changeShow less
    • Eligibility criteria expanded, about 29 words

    See this version in full on ClinicalTrials.gov ↗

Show 11 earlier versionsHide 11 earlier versions
  1. Primary completion date: Mar 1, 2025 to Mar 1, 2027 Completion date: Jun 1, 2026 to Jun 1, 2028v12 Show 1 more changeShow less
    • Completion date: Jun 1, 2026 to Jun 1, 2028
  2. Trial status: Suspended to Recruiting Site details revised at 2 of 2 sitesv11 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  3. Re-verified, no change to tracked fieldsv10
  4. Trial status: Recruiting to Suspended Sponsor's reason: Study enrollment temporarily on hold pending availability of the FFNP radiotracer Site details revised at 2 of 2 sitesv9 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  5. Start date changed from estimate of Aug 8, 2024 to Jul 22, 2024v8
  6. Trial status: Not Yet Recruiting to Recruiting Site details revised at 2 of 2 sitesv7 Show 1 more changeShow less
    • Site details revised at 2 of 2 sites
  7. Start date: Jul 6, 2024 to Aug 8, 2024v6
  8. Start date: Jun 1, 2024 to Jul 6, 2024v5
  9. Completion date: Mar 1, 2025 to Jun 1, 2026 Study description expanded, about 8 words · Study sites revised (2) · Eligibility criteria expanded, about 3 wordsv4 Show 3 more changesShow less
    • Study description expanded, about 8 words
    • Study sites revised (2)
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  10. Re-verified, no change to tracked fieldsv3
  11. Study sites: 1 to 2v2
  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 phase II trial tests the accuracy of functional imaging (FFNP)-positron emission tomography (PET)/computed tomography (CT) to predict response to abemaciclib plus endocrine therapy. Abemaciclib is a drug used to treat certain types of hormone receptor positive (HR+), HER2 negative breast cancer. Abemaciclib blocks certain proteins, which may help keep tumor cells from growing. Endocrine therapy adds, blocks, or removes hormones that can cause cancer to grow. FFNP PET imaging is a form of x-ray that uses FFNP as an imaging agent that may provide more precise information about the location of tumors that "light up" with FFNP than a PET scan alone can provide.
Trial Details
NCT Number NCT06179303
Lead Sponsor University of Washington
Collaborators: Breast Cancer Research Foundation
Conditions Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Unresectable HER2-Negative Breast Carcinoma, Locally Advanced Unresectable Hormone Receptor-Positive Breast Carcinoma, Metastatic HER2-Negative Breast Carcinoma, Metastatic Hormone Receptor-Positive Breast Carcinoma
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov