deltatrials
Active Not Recruiting NA INTERVENTIONAL 1-arm NCT01208974

Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Reconstruction

A Phase I Trial Assessing the Safety and Feasibility of Prophylactic Nipple-Areola Complex (NAC) Irradiation After Nipple-Sparing Mastectomy and Immediate Reconstruction in Patients With In-Situ or Invasive Breast Cancer

Sponsor: University of Miami

Conditions Breast Cancer Ductal Carcinoma
Interventions Axillary Surgery Breast Reconstruction Nipple-Sparing Mastectomy Prophylactic Nipple-Areolar Complex RT
Updated 19 times since 2017 Last updated: Jun 18, 2025 Started: Mar 16, 2010 Primary completion: Feb 13, 2018 Completion: May 31, 2026
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A NA clinical study on Breast Cancer and Ductal Carcinoma, this trial is ongoing. The trial is conducted by University of Miami and has accumulated 19 data snapshots since 2010. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~May 2017 · 3 months · monthly snapshot~May 2017 – ~Apr 2018 · 11 months · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Nov 2018 · 5 months · monthly snapshot~Nov 2018 – ~Feb 2019 · 3 months · monthly snapshot~Feb 2019 – ~Aug 2019 · 6 months · monthly snapshot~Aug 2019 – ~Jan 2020 · 5 months · monthly snapshot~Jan 2020 – ~Jun 2020 · 5 months · monthly snapshot~Jun 2020 – ~Nov 2020 · 5 months · monthly snapshot~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Feb 2022 · 13 months · monthly snapshot~Feb 2022 – ~Jan 2023 · 11 months · monthly snapshot~Jan 2023 – ~Jun 2023 · 5 months · monthly snapshot~Jun 2023 – ~Jun 2024 · 12 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jul 2025 · 10 months · monthly snapshot~Jul 2025 – present · 14 months · monthly snapshot

Change History

19 versions recorded

  1. Jul 2025 — Present [monthly]

    Active Not Recruiting NA

  2. Sep 2024 — Jul 2025 [monthly]

    Active Not Recruiting NA

  3. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting NA

  4. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting NA

  5. Jun 2023 — Jun 2024 [monthly]

    Active Not Recruiting NA

▶ Show 14 earlier versions

  1. Jan 2023 — Jun 2023 [monthly]

    Active Not Recruiting NA

  2. Feb 2022 — Jan 2023 [monthly]

    Active Not Recruiting NA

    Phase: PHASE1 → NA

  3. Jan 2021 — Feb 2022 [monthly]

    Active Not Recruiting PHASE1

  4. Nov 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1

    Phase: NA → PHASE1

  5. Jun 2020 — Nov 2020 [monthly]

    Active Not Recruiting NA

  6. Jan 2020 — Jun 2020 [monthly]

    Active Not Recruiting NA

  7. Aug 2019 — Jan 2020 [monthly]

    Active Not Recruiting NA

  8. Feb 2019 — Aug 2019 [monthly]

    Active Not Recruiting NA

    Status: Recruiting → Active Not Recruiting

  9. Nov 2018 — Feb 2019 [monthly]

    Recruiting NA

  10. Jun 2018 — Nov 2018 [monthly]

    Recruiting NA

  11. Apr 2018 — Jun 2018 [monthly]

    Recruiting NA

  12. May 2017 — Apr 2018 [monthly]

    Recruiting NA

    Phase: PHASE1 → NA

  13. Feb 2017 — May 2017 [monthly]

    Recruiting PHASE1

  14. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1

    First recorded

Mar 2010

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • University of Miami
Data source: University of Miami

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

Study Locations