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S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Enrollment target: 817 to 491 Eligibility criteria expanded, about 62 words · Study description shortened, about 8 words · Study title expanded, about 6 wordsv19 Show 3 more changesShow less
    • Eligibility criteria expanded, about 62 words
    • Study description shortened, about 8 words
    • Study title expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary and study completion dates: Jan 1, 2030 to Sep 15, 2027v18
  3. Primary and study completion dates: Jan 1, 2029 to Jan 1, 2030v17
  4. Study sites: 586 to 590v16
  5. Start date: Sep 15, 2017 to Nov 1, 2017v15
Show 13 earlier versionsHide 13 earlier versions
  1. Site details revised at 12 of 586 sitesv14
  2. Study sites: 580 to 586v13
  3. Study sites: 569 to 580v12
  4. Primary and study completion dates: Feb 1, 2023 to Jan 1, 2029v11
  5. Study sites: 568 to 569v10
  6. Study sites: 566 to 568v9
  7. Study sites: 559 to 566v8
  8. Re-verified, no change to tracked fieldsv7
  9. Study sites: 555 to 559v6
  10. Study sites: 523 to 555v5
  11. Study sites: 522 to 523v4
  12. Study sites: 1 to 522v3
  13. Primary endpoints: 5 to 1 Secondary endpoints: 1 to 5v2 Show 1 more changeShow less
    • Secondary endpoints: 1 to 5

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 trial has two cohorts of patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. All patients must be receiving trastuzumab-based treatment. Both cohorts are being observed for cardiac toxicity. The largest cohort (currently open to accrual) is observational, and contains patients who are taking a beta blocker, ACE inhibitor, or ARB as well as their trastuzumab-based treatment. The goal is to understand how common cardiac problems are in this group of patients at high risk. The smaller cohort (currently closed to accrual) is randomized. Patients in this second cohort are randomized to either carvedilol or no treatment, with the goal of seeing whether carvedilol (used to treat heart failure and high blood pressure) may prevent the heart from side effects of chemotherapy.
Trial Details
NCT Number NCT03418961
Lead Sponsor SWOG Cancer Research Network
Collaborators: National Cancer Institute (NCI)
Conditions Cardiotoxicity, HER2/Neu Positive, Metastatic Malignant Neoplasm in the Brain, Recurrent Breast Carcinoma, Stage IV Breast Cancer AJCC v6 and v7
Enrollment 491 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov