A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer

StatusActive, Not Recruiting
PhasePhase 1/2
Started

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Record History

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  1. Enrollment closed, study ongoing
    • Eligibility criteria expanded, about 62 words
    • Site details revised at 7 of 7 sites
    • Collaborators: details revised at 1 of 1 entry
  2. Enrollment target: 54 to 56v14
  3. Enrollment increased: 49 → 54 participantsv13
  4. Primary and study completion dates: Nov 2026 to Nov 2027v12
  5. Enrollment target: 43 to 49v11
Show 9 earlier versionsHide 9 earlier versions
  1. 7 versions Re-verified since Jul 26, 2024, no change to tracked fieldsv4-v10
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2024 to Dec 29, 2023
    • Site details revised at 7 of 7 sites
    v3
  3. Start date: Nov 2023 to Jan 2024v2
  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.
The purpose of this study is to test whether the combination of lenvatinib, pembrolizumab, and fulvestrant is a safe and effective treatment that causes few or mild side effects in people with ER+/HER2- metastatic breast cancer.
Trial Details
NCT Number NCT06110793
Lead Sponsor Memorial Sloan Kettering Cancer Center
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Metastatic Breast Cancer
Related terms Breast Neoplasms
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov