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Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Minor Start date changed from estimate of Mar 15, 2026 to Mar 3, 2026v13
  2. Minor Eligibility criteria revisedv12
  3. Notable Start date: Jan 15, 2026 to Mar 15, 2026
    • Eligibility criteria expanded, about 31 words
    v11
  4. Notable Start date: Nov 15, 2025 to Jan 15, 2026v10
  5. Minor Enrollment target: 31 to 30v9
Show 7 earlier versionsHide 7 earlier versions
  1. Notable Start date: Sep 15, 2025 to Nov 15, 2025
    • Eligibility criteria expanded, about 34 words
    v8
  2. Notable Start date: Jul 15, 2025 to Sep 15, 2025v7
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: May 15, 2025 to Jul 15, 2025
    • Site details revised
    v6
  4. Notable Start date: Feb 15, 2025 to May 15, 2025v5
  5. Notable Start date: Nov 30, 2024 to Feb 15, 2025v4
  6. Notable Start date: Sep 30, 2024 to Nov 30, 2024
    • Primary and study completion dates: Sep 30, 2028 to Nov 30, 2028
    v3
  7. Notable Start date: Jun 30, 2024 to Sep 30, 2024
    • Primary and study completion dates: Jun 30, 2028 to Sep 30, 2028
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 tamoxifen and pegylated liposomal doxorubicin works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that has spread to nearby tissue or lymph nodes (locally advanced) and is unable to be operated on (inoperable). Tamoxifen works by blocking the effects of estrogen in the breast. This may help stop the growth of tumor cells that need estrogen to grow. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Giving tamoxifen and pegylated liposomal doxorubicin together may work better in treating patients with metastatic or inoperable, locally advanced triple negative breast cancer than giving either of these drugs alone.
Trial Details
NCT Number NCT06434064
Lead Sponsor Roswell Park Cancer Institute
Conditions
(from sponsor)
Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8, Locally Advanced Unresectable Triple-Negative Breast Carcinoma, Metastatic Triple-Negative Breast Carcinoma
Related terms Triple Negative Breast Neoplasms
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov