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Biomarkers to Detect Endocrine Therapy Resistance

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Aug 2026 → Dec 2026
See other at-risk trials from University of Wisconsin, Madison

Record History

  1. Primary and study completion pushed from Aug 2026 to Dec 2026v10
  2. Re-verified, no change to tracked fieldsv9
  3. Primary and study completion dates: Jan 2026 to Aug 2026v8
  4. Start date changed from estimate of May 2024 to Apr 30, 2024v7
  5. Start date: Apr 2024 to May 2024v6
Show 4 earlier versionsHide 4 earlier versions
  1. Start date: Mar 2024 to Apr 2024v5
  2. Start date: Feb 2024 to Mar 2024v4
  3. Start date: Jan 2024 to Feb 2024v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 pilot observational study is being done to identify possible biomarkers of response to endocrine therapy in patients with ER/PR+ metastatic lobular breast cancer (LBC) starting new endocrine therapy. 18F-fluorofuranylnorprogesterone Positron Emission Tomography/Computed Tomography (FFNP-PET/CT) and liquid biopsies will be performed at baseline and after 4 weeks of treatment. Baseline levels and dynamic on-treatment changes in estrogen signaling as measured by FFNP-PET/CT and circulating tumor cell (CTC) liquid biopsy will be correlated with clinical response to endocrine therapy and progression-free survival in the above cohort of patients.
Trial Details
NCT Number NCT06067503
Lead Sponsor University of Wisconsin, Madison
Conditions
(from sponsor)		 Metastatic Cancer, Breast Cancer, Lobular Breast Carcinoma
Related terms Breast Neoplasms, Carcinoma, Lobular, Neoplasm Metastasis, Neoplastic Cells, Circulating
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov