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Clinical Trial Assessing the Safety of Neoadjuvant Palbociclib in Combination With Endocrine Therapy

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion date changed from estimate of Sep 2026 to Jun 22, 2026 Eligibility criteria expanded, about 26 words · Secondary endpoints: details revised at 2 of 3 entries · Study description revised Show 3 more changesShow less
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 2 of 3 entries
    • Study description revised
  2. Re-verified, no change to tracked fieldsv11
  3. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 46 to confirmed 51 · Site details revisedv10 Show 2 more changesShow less
    • Enrollment target: estimated 46 to confirmed 51
    • Site details revised
  4. Primary completion date: Sep 2025 to Sep 2026 Completion date: Sep 2031 to Sep 2032v9 Show 1 more changeShow less
    • Completion date: Sep 2031 to Sep 2032
  5. Re-verified, no change to tracked fieldsv8
Show 6 earlier versionsHide 6 earlier versions
  1. Primary completion date: Sep 1, 2025 to Sep 2025 Completion date: Sep 1, 2031 to Sep 2031v7 Show 1 more changeShow less
    • Completion date: Sep 1, 2031 to Sep 2031
  2. Re-verified, no change to tracked fieldsv6
  3. Lead sponsor: Jairam Krishnamurthy to University of Nebraska Primary endpoints revised (2) · Secondary endpoints revised (3) · Study description expanded, about 195 words · 1 morev5 Show 4 more changesShow less
    • Primary endpoints revised (2)
    • Secondary endpoints revised (3)
    • Study description expanded, about 195 words
    • Study site revised

    See this version in full on ClinicalTrials.gov ↗

  4. 2 versions Re-verified since Mar 22, 2023, no change to tracked fieldsv3-v4
  5. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Nov 1, 2021 to Mar 2, 2022 · Study sites: 0 to 1 · Primary completion date: Apr 1, 2025 to Sep 1, 2025 · 1 morev2 Show 4 more changesShow less
    • Start date changed from estimate of Nov 1, 2021 to Mar 2, 2022
    • Study sites: 0 to 1
    • Primary completion date: Apr 1, 2025 to Sep 1, 2025
    • Completion date: Apr 1, 2031 to Sep 1, 2031
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Patients with estrogen receptor positive (ER+) and/or progesterone receptor positive (PR+) breast cancer do not achieve good responses with pre-operative chemotherapy. The sensitivity of breast cancer to chemotherapy is often determined by the underlying gene expression pattern and the molecular subtype of the tumor. In addition, not all patients tolerate chemotherapy well. Pre-operative endocrine therapy has emerged as an effective strategy to improve outcomes in patients with early-stage hormone receptor positive breast cancer. This study will assess the role of neo-adjuvant palbociclib (CDK 4/6 inhibitor) in combination with letrozole (aromatase inhibitor) +/-Goserelin (GnRH analogue) to improve overall response and surgical feasibility in post and pre-menopausal hormone receptor positive and Her-2 negative subjects with stage IIA-IIIC breast cancer.
Trial Details
NCT Number NCT05069038
Lead Sponsor University of Nebraska
Conditions Breast Cancer
Enrollment 51 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov