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Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Start date: May 30, 2024 to Jun 11, 2024v9
  2. Start date changed from estimate of Jan 31, 2025 to May 30, 2024 Site details revised at 1 of 5 sitesv8 Show 1 more changeShow less
    • Site details revised at 1 of 5 sites
  3. Start date: Sep 30, 2024 to Jan 31, 2025v7
  4. Trial status: Not Yet Recruiting to Recruiting Site details revised at 5 of 5 sitesv6 Show 1 more changeShow less
    • Site details revised at 5 of 5 sites
  5. Primary completion date: Jan 30, 2029 to Apr 30, 2030 Start date: Apr 30, 2024 to Sep 30, 2024 · Completion date: Jan 30, 2030 to Apr 30, 2031v5 Show 2 more changesShow less
    • Start date: Apr 30, 2024 to Sep 30, 2024
    • Completion date: Jan 30, 2030 to Apr 30, 2031
Show 3 earlier versionsHide 3 earlier versions
  1. Start date: Dec 30, 2023 to Apr 30, 2024 Primary completion date: Oct 30, 2028 to Jan 30, 2029 · Completion date: Oct 30, 2029 to Jan 30, 2030v4 Show 2 more changesShow less
    • Primary completion date: Oct 30, 2028 to Jan 30, 2029
    • Completion date: Oct 30, 2029 to Jan 30, 2030
  2. Start date: Oct 30, 2023 to Dec 30, 2023 Eligibility criteria expanded, about 157 wordsv3 Show 1 more changeShow less
    • Eligibility criteria expanded, about 157 words

    See this version in full on ClinicalTrials.gov ↗

  3. Start date: Jul 30, 2023 to Oct 30, 2023 Primary completion date: Jul 30, 2028 to Oct 30, 2028 · Completion date: Jul 30, 2029 to Oct 30, 2029v2 Show 2 more changesShow less
    • Primary completion date: Jul 30, 2028 to Oct 30, 2028
    • Completion date: Jul 30, 2029 to Oct 30, 2029
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 how well neratinib prior to the primary treatment (neoadjuvant) works in treating patients with stage I-III HER2 mutated lobular breast cancers. Neratinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells. Giving neratinib in addition to normal therapy may work better in treating cancer than the endocrine therapy patients would normally receive.
Trial Details
NCT Number NCT05919108
Lead Sponsor Vanderbilt-Ingram Cancer Center
Collaborators: National Cancer Institute (NCI), Puma Biotechnology, Inc.
Conditions Anatomic Stage I Breast Cancer, Anatomic Stage II Breast Cancer, Anatomic Stage III Breast Cancer, Invasive Breast Lobular Carcinoma
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov