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Carboplatin and Paclitaxel With or Without Atezolizumab Before Surgery in Treating Patients With Newly Diagnosed, Stage II-III Triple-Negative Breast Cancer

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 79 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Completion pushed from Sep 11, 2026 to Sep 30, 2027
  2. Re-verified, no change to tracked fields
  3. Completion date: Sep 11, 2026 to Sep 30, 2027 Eligibility criteria expanded, about 43 words · Site details revised at 1 of 14 sites Show 2 more changesShow less
    • Eligibility criteria expanded, about 43 words
    • Site details revised at 1 of 14 sites
  4. Study sites revised (14)v77 See this version in full on ClinicalTrials.gov ↗
  5. 2 versions Re-verified since Mar 28, 2026, no change to tracked fieldsv75-v76
Show 45 earlier versionsHide 45 earlier versions
  1. Completion date: Jul 1, 2026 to Sep 11, 2026v74
  2. Trial status: Completed to Active, Not Recruiting Completion date: Dec 20, 2020 to Jul 1, 2026v73 Show 1 more changeShow less
    • Completion date: Dec 20, 2020 to Jul 1, 2026
  3. Trial status: Active, Not Recruiting to Completed Study completion date changed from estimate of Jan 23, 2025 to Dec 20, 2020v72 Show 1 more changeShow less
    • Study completion date changed from estimate of Jan 23, 2025 to Dec 20, 2020
  4. Results first posted: Jun 18, 2024v71
  5. Primary endpoints: 1 to 2v70 See this version in full on ClinicalTrials.gov ↗
  6. Primary completion date: Nov 9, 2022 to Dec 18, 2019 Completion date: Dec 17, 2024 to Jan 23, 2025v69 Show 1 more changeShow less
    • Completion date: Dec 17, 2024 to Jan 23, 2025
  7. Start date: May 17, 2017 to Aug 2, 2017 Enrollment target: estimated 72 to confirmed 67 · Primary completion date changed from estimate of Jul 1, 2023 to Nov 9, 2022 · Completion date: Jul 1, 2023 to Dec 17, 2024v68 Show 3 more changesShow less
    • Enrollment target: estimated 72 to confirmed 67
    • Primary completion date changed from estimate of Jul 1, 2023 to Nov 9, 2022
    • Completion date: Jul 1, 2023 to Dec 17, 2024
  8. Re-verified, no change to tracked fieldsv67
  9. Interventions: Atezolizumab (Drug), Carboplatin (Drug), Lumpectomy (Procedure), Mastectomy (Procedure), Paclitaxel (Drug) to Atezolizumab (Drug), Biospecimen Collection (Procedure), Carboplatin (Drug), Lumpectomy (Procedure), Mastectomy (Procedure), Paclitaxel… Study description expanded, about 11 words · Eligibility criteria expanded, about 4 wordsv66 Show 2 more changesShow less
    • Study description expanded, about 11 words
    • Eligibility criteria expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  10. Re-verified, no change to tracked fieldsv65
  11. Primary and study completion dates: Jul 1, 2022 to Jul 1, 2023v64
  12. 4 versions Re-verified since Jul 23, 2021, no change to tracked fieldsv60-v63
  13. Primary and study completion dates: Jul 1, 2021 to Jul 1, 2022v59
  14. 3 versions Re-verified since Oct 17, 2020, no change to tracked fieldsv56-v58
  15. Primary and study completion dates: Jul 1, 2020 to Jul 1, 2021v55
  16. Study sites revised (14)v54 See this version in full on ClinicalTrials.gov ↗
  17. 3 versions Re-verified since Apr 14, 2020, no change to tracked fieldsv51-v53
  18. Study description revisedv50 See this version in full on ClinicalTrials.gov ↗
  19. 5 versions Re-verified since Oct 28, 2019, no change to tracked fieldsv45-v49
  20. Trial status: Suspended to Active, Not Recruitingv44
  21. 3 versions Re-verified since Sep 11, 2019, no change to tracked fieldsv41-v43
  22. Trial status: Recruiting to Suspended Sponsor's reason: Other - pending preliminary analysis Site details revised at 14 of 14 sitesv40 Show 1 more changeShow less
    • Site details revised at 14 of 14 sites
  23. Site contacts updated at 1 of 14 sitesv39
  24. Trial status: Suspended to Recruiting Site details revised at 14 of 14 sitesv38 Show 1 more changeShow less
    • Site details revised at 14 of 14 sites
  25. Enrollment target: 60 to 72 Interventions: Atezolizumab (Drug), Carboplatin (Drug), Laboratory Biomarker Analysis (Other), Lumpectomy (Procedure), Mastectomy (Procedure), Paclitaxel… to Atezolizumab (Drug), Carboplatin (Drug), Lumpectomy (Procedure), Mastectomy (Procedure), Paclitaxel (Drug) · Study description revisedv37 Show 2 more changesShow less
    • Interventions: Atezolizumab (Drug), Carboplatin (Drug), Laboratory Biomarker Analysis (Other), Lumpectomy (Procedure), Mastectomy (Procedure), Paclitaxel… to Atezolizumab (Drug), Carboplatin (Drug), Lumpectomy (Procedure), Mastectomy (Procedure), Paclitaxel (Drug)
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  26. Re-verified, no change to tracked fieldsv36
  27. Primary and study completion dates: May 17, 2019 to Jul 1, 2020v35
  28. Re-verified, no change to tracked fieldsv34
  29. Trial status: Recruiting to Suspended Sponsor's reason: Other - Amendment pending to replace non-evaluable pts Site details revised at 14 of 14 sitesv33 Show 1 more changeShow less
    • Site details revised at 14 of 14 sites
  30. Site contacts updated at 1 of 14 sitesv32
  31. Site contacts updated at 3 of 14 sitesv31
  32. Site contacts updated at 6 of 14 sitesv30
  • 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 studies how well carboplatin and paclitaxel with or without atezolizumab before surgery works in treating patients with newly diagnosed, stage II-III triple negative breast cancer. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving carboplatin and paclitaxel with or without atezolizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
Trial Details
NCT Number NCT02883062
Lead Sponsor National Cancer Institute (NCI)
Conditions Invasive Breast Carcinoma, Stage II Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Triple-Negative Breast Carcinoma
Enrollment 67 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov