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Phase 1b Study of Pegylated Liposomal Doxorubicin and Pembrolizumab in Endocrine-resistant Breast Cancer

Study acronym: KEYDOX
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 23, 2020 (before its estimated April 15, 2021 completion). Its status may not reflect the trial's current state.

Record History

  1. Primary completion date: Mar 15, 2020 to Apr 15, 2021 Completion date: Jun 15, 2020 to Jun 15, 2021v6 Show 1 more changeShow less
    • Completion date: Jun 15, 2020 to Jun 15, 2021
  2. Re-verified, no change to tracked fieldsv5
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Aug 15, 2018 to Apr 18, 2019 · Site details revisedv4 Show 2 more changesShow less
    • Start date changed from estimate of Aug 15, 2018 to Apr 18, 2019
    • Site details revised
  4. Start date: Jul 15, 2018 to Aug 15, 2018v3
  5. Secondary endpoints revised (2) Study title shortened, about 2 wordsv2 Show 1 more changeShow less
    • Study title shortened, about 2 words

    See this version in full on ClinicalTrials.gov ↗

  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Very few patients with endocrine-resistant, hormone-receptor positive metastatic breast cancer respond to single agent immunotherapy. Responses to chemotherapy are usually of short duration. Combining immunotherapy with chemotherapy that has minimal immunosuppressive effect, it may be possible to achieve higher response rates while keeping the immune-associated pattern of long durations of response. This will be a single-center phase 1b study to evaluate the tumor response and appropriate dose of a chemo-immunotherapy regime consisting of treatment with pegylated liposomal doxorubicin (PLD) and pembrolizumab-based in endocrine-resistant breast cancer (ERBC) patients. Up to 15 female patients, ages 18 and above, with pathological diagnosis of breast cancer, estrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2-) negative subtype, stage III non-operable, or stage IV disease, who have received at least two lines of hormonal therapy, one of which included aromatase inhibitors will be eligible for enrollment to this single arm study.
Trial Details
NCT Number NCT03591276
Lead Sponsor Shaare Zedek Medical Center
Conditions Metastatic Breast Cancer
Enrollment 15 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov