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Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 5 of 5 entries
    • Site details revised at 80 of 1024 sites
    • Publications: details revised at 2 of 2 entries
  2. 9 versions Re-verified since Nov 11, 2025, no change to tracked fieldsv13-v21
  3. Site details revised at 1 of 1024 sitesv12
  4. Re-verified, no change to tracked fieldsv11
  5. Start date: Apr 29, 2015 to Oct 20, 2015v10
Show 8 earlier versionsHide 8 earlier versions
  1. Re-verified, no change to tracked fieldsv9
  2. Results first posted: Oct 5, 2022v8 Show 11 more changesShow less
    • Primary endpoint revised
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 562 to confirmed 415
    • Primary completion date changed from estimate of May 31, 2021 to Apr 7, 2021
    • Study completion date: May 31, 2024 to Mar 29, 2031
    • Interventions: Capecitabine (Drug), Carboplatin (Drug), Cisplatin (Drug), Laboratory Biomarker Analysis (Other), Quality-of-Life Assessment (Procedure)… to Capecitabine (Drug), Carboplatin (Drug), Cisplatin (Drug)
    • Eligibility criteria shortened, about 90 words
    • Secondary endpoints revised (5)
    • Study description expanded, about 276 words
    • Site details revised at 1024 of 1024 sites
    • Study title shortened, about 5 words
  3. Study sites: 1013 to 1024v7
  4. Primary completion date: May 31, 2019 to May 31, 2021
    • Study sites: 907 to 1013
    v6
  5. Study sites: 849 to 907v5
  6. Study sites: 838 to 849
    • Study completion date: May 31, 2024
    v4
  7. Primary endpoint revisedv3 Show 7 more changesShow less
    • Study sites: 635 to 838
    • Primary completion date: May 2019 to May 31, 2019
    • Start date: Apr 2015 to Apr 29, 2015
    • Interventions: Capecitabine (Drug), Carboplatin (Drug), Cisplatin (Drug), Laboratory Biomarker Analysis (Other) to Capecitabine (Drug), Carboplatin (Drug), Cisplatin (Drug), Laboratory Biomarker Analysis (Other), Quality-of-Life Assessment (Procedure)…
    • Eligibility criteria expanded, about 175 words
    • Secondary endpoints: 4 to 5
    • Study description expanded, about 50 words
  8. Enrollment target: 558 to 562v2 Show 7 more changesShow less
    • Study sites: 1 to 635
    • Interventions: Carboplatin (Drug), Cisplatin (Drug), Laboratory Biomarker Analysis (Other), Quality-of-Life Assessment (Other) to Capecitabine (Drug), Carboplatin (Drug), Cisplatin (Drug), Laboratory Biomarker Analysis (Other)
    • Eligibility criteria expanded, about 33 words
    • Secondary endpoints revised (4)
    • Study description expanded, about 71 words
    • Study title revised
    • Study arms: 2 to 3
  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 randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to capecitabine in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin, carboplatin and capecitabine, 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. It is not yet known whether cisplatin or carboplatin is more effective than capecitabine in treating patients with residual triple negative basal-like breast cancer.
Trial Details
NCT Number NCT02445391
Lead Sponsor ECOG-ACRIN Cancer Research Group
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Estrogen Receptor Negative, HER2/Neu Negative, Invasive Breast Carcinoma, Progesterone Receptor Negative, Stage II Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage III Breast Cancer +4 more
Related terms Breast Neoplasms, Triple Negative Breast Neoplasms
Enrollment 415 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov