deltatrials
Completed PHASE1/PHASE2 INTERVENTIONAL 1-arm NCT00278109

Partial Breast Irradiation With Chemotherapy

Phase I/II Partial Breast Irradiation With Concurrent Chemotherapy

Sponsor: National Cancer Institute (NCI)

Conditions Breast Cancer
Updated 9 times since 2017 Last updated: Feb 11, 2020 Started: Jul 31, 2004 Primary completion: Dec 31, 2016 Completion: Dec 31, 2016
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1/PHASE2 trial investigates Breast Cancer and is currently completed. National Cancer Institute (NCI) leads this study, which shows 9 recorded versions since 2004 — indicating limited longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Study Description(click to expand)

OBJECTIVES: * Assess the potential acute and late skin and subcutaneous toxicities in women with resected stage I or II breast cancer treated with partial breast irradiation (PBI) and concurrent cyclophosphamide/doxorubicin (AC) chemotherapy. * Assess the cosmetic effects of partial breast irradiation/chemotherapy (PBIC) in these patients. * Assess the local control rate in patients treated with this regimen. OUTLINE: Patients undergo partial breast radiotherapy once daily, 5 days a week, for 3 weeks. Patients also receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment with doxorubicin and cyclophosphamide repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for approximately 10 years. PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

OBJECTIVES:

* Assess the potential acute and late skin and subcutaneous toxicities in women with resected stage I or II breast cancer treated with partial breast irradiation (PBI) and concurrent cyclophosphamide/doxorubicin (AC) chemotherapy. * Assess the cosmetic effects of partial breast irradiation/chemotherapy (PBIC) in these patients. * Assess the local control rate in patients treated with this regimen.

OUTLINE: Patients undergo partial breast radiotherapy once daily, 5 days a week, for 3 weeks. Patients also receive doxorubicin IV over 15 minutes and cyclophosphamide IV over 30 minutes on day 1. Treatment with doxorubicin and cyclophosphamide repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for approximately 10 years.

PROJECTED ACCRUAL: A total of 42 patients will be accrued for this study.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotUnknown Status~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotUnknown Status~Jun 2018 – ~Apr 2019 · 10 months · monthly snapshotUnknown Status~Apr 2019 – ~Mar 2020 · 11 months · monthly snapshotCompleted~Mar 2020 – ~Jan 2021 · 10 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 19 months · monthly snapshotCompleted~Jan 2026 – present · 3 months · monthly snapshotCompleted

Change History

9 versions recorded
  1. Jan 2026 — Present [monthly]

    Completed PHASE1/PHASE2

  2. Sep 2024 — Present [monthly]

    Completed PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1/PHASE2

    Phase: PHASE1_PHASE2PHASE1/PHASE2

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1_PHASE2

  5. Mar 2020 — Jan 2021 [monthly]

    Completed PHASE1_PHASE2

Show 4 earlier versions
  1. Apr 2019 — Mar 2020 [monthly]

    Completed PHASE1_PHASE2

    Status: Unknown StatusCompleted

  2. Jun 2018 — Apr 2019 [monthly]

    Unknown Status PHASE1_PHASE2

  3. Feb 2017 — Jun 2018 [monthly]

    Unknown Status PHASE1_PHASE2

  4. Jan 2017 — Feb 2017 [monthly]

    Unknown Status PHASE1_PHASE2

    First recorded

Jul 2004

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)
  • Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Data source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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

Study Locations