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A Study of Pembrolizumab With Carboplatin and Gemcitabine in Patients With Metastatic Triple Negative Breast Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 4, 2025 (before its estimated May 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: May 2025 to May 2026v19
  2. Primary completion date: May 2024 to May 2025
    • Study completion date: Apr 2025 to May 2026
    v18
  3. Primary completion date: Oct 2023 to May 2024v17
  4. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 6 of 6 sites
    v16
  5. Primary completion date: Oct 2022 to Oct 2023v15
Show 13 earlier versionsHide 13 earlier versions
  1. Primary completion date: Oct 2021 to Oct 2022
    • Study completion date: Apr 2024 to Apr 2025
    v14
  2. Re-verified, no change to tracked fieldsv13
  3. Study sites: 5 to 6v12
  4. Re-verified, no change to tracked fieldsv11
  5. Primary completion date: Oct 2019 to Oct 2021v10
  6. Study sites: 4 to 5v9
  7. Enrollment target: 75 to 87
    • Eligibility criteria shortened, about 26 words
    v8
  8. Enrollment target: 87 to 75v7
  9. Study sites: 3 to 4
    • Collaborators expanded, about 4 words
    v6
  10. Eligibility criteria expanded, about 1,051 wordsv5
  11. Primary completion date: Oct 2018 to Oct 2019
    • Study sites: 1 to 3
    • Study completion date: Apr 2023 to Apr 2024
    • Start date: May 2016 to May 31, 2016
    v4
  12. Primary completion date: Jun 2019 to Oct 2018
    • Study completion date: Apr 2023
    v3
  13. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 2016 to May 2016
    • Site details revised
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The main purpose of this study is to see if Pembrolizumab in combination with chemotherapy (carboplatin and gemcitabine) is safe and effective in treating patients with metastatic triple negative breast cancer. Pembrolizumab is a drug which may help the immune system to target and destroy cancer cells. Pembrolizumab has been approved by the FDA for the treatment of advanced melanoma and metastatic non-small cell lung cancer. However, it has not been approved as a treatment for breast cancer.
Trial Details
NCT Number NCT02755272
Lead Sponsor Fox Chase Cancer Center
Collaborators: University of Wisconsin, Madison
Conditions
(from sponsor)		 Carcinoma Breast Stage IV
Related terms Breast Neoplasms, Triple Negative Breast Neoplasms
Enrollment 87 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov