deltatrials
Recruiting PHASE3 INTERVENTIONAL 3-arm NCT03418961

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

Prospective Observational Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity

Sponsor: 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
Interventions Carvedilol Laboratory Biomarker Analysis Patient Observation
Updated 22 times since 2018 Last updated: Oct 3, 2025 Started: Nov 1, 2017 Primary completion: Sep 15, 2027 Completion: Sep 15, 2027
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03418961, this PHASE3 trial focuses on Cardiotoxicity and HER2/Neu Positive and remains actively recruiting participants. Sponsored by National Cancer Institute (NCI), it has been updated 22 times since 2017, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Sep 2018 · 2 months · monthly snapshot~Sep 2018 – ~Sep 2019 · 12 months · monthly snapshot~Sep 2019 – ~Oct 2020 · 13 months · monthly snapshot~Oct 2020 – ~Dec 2020 · 2 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~Jun 2021 · 3 months · monthly snapshot~Jun 2021 – ~Dec 2021 · 6 months · monthly snapshot~Dec 2021 – ~Dec 2022 · 12 months · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~May 2023 · 3 months · monthly snapshot~May 2023 – ~Jul 2023 · 2 months · monthly snapshot~Jul 2023 – ~Sep 2023 · 2 months · monthly snapshot~Sep 2023 – ~May 2024 · 8 months · monthly snapshot~May 2024 – ~Jul 2024 · 2 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jun 2025 · 9 months · monthly snapshot~Jun 2025 – ~Sep 2025 · 3 months · monthly snapshot~Sep 2025 – ~Nov 2025 · 2 months · monthly snapshot~Nov 2025 – present · 7 months · monthly snapshot

Change History

22 versions recorded

  1. Nov 2025 — Present [monthly]

    Recruiting PHASE3

  2. Sep 2025 — Nov 2025 [monthly]

    Recruiting PHASE3

  3. Jun 2025 — Sep 2025 [monthly]

    Recruiting PHASE3

  4. Sep 2024 — Jun 2025 [monthly]

    Recruiting PHASE3

  5. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE3

▶ Show 17 earlier versions

  1. May 2024 — Jul 2024 [monthly]

    Recruiting PHASE3

  2. Sep 2023 — May 2024 [monthly]

    Recruiting PHASE3

  3. Jul 2023 — Sep 2023 [monthly]

    Recruiting PHASE3

  4. May 2023 — Jul 2023 [monthly]

    Recruiting PHASE3

  5. Feb 2023 — May 2023 [monthly]

    Recruiting PHASE3

  6. Dec 2022 — Feb 2023 [monthly]

    Recruiting PHASE3

  7. Dec 2021 — Dec 2022 [monthly]

    Recruiting PHASE3

  8. Jun 2021 — Dec 2021 [monthly]

    Recruiting PHASE3

  9. Mar 2021 — Jun 2021 [monthly]

    Recruiting PHASE3

  10. Jan 2021 — Mar 2021 [monthly]

    Recruiting PHASE3

  11. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  12. Oct 2020 — Dec 2020 [monthly]

    Recruiting PHASE3

  13. Sep 2019 — Oct 2020 [monthly]

    Recruiting PHASE3

  14. Sep 2018 — Sep 2019 [monthly]

    Recruiting PHASE3

  15. Jul 2018 — Sep 2018 [monthly]

    Recruiting PHASE3

  16. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE3

  17. Mar 2018 — Jun 2018 [monthly]

    Recruiting PHASE3

    First recorded

Nov 2017

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Cancer Institute (NCI)
  • SWOG Cancer Research Network
Data source: SWOG Cancer Research Network

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Aberdeen, United States , Aguadilla, Puerto Rico , Akron, United States , Albuquerque, United States , Allentown, United States , Anaconda, United States , Anchorage, United States , Ann Arbor, United States , Antioch, United States , Arecibo, Puerto Rico and 361 more locations