Partial Breast Irradiation With Chemotherapy
Phase I/II Partial Breast Irradiation With Concurrent Chemotherapy
Sponsor: National Cancer Institute (NCI)
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
Change History
9 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE1/PHASE2
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Sep 2024 — Present [monthly]
Completed PHASE1/PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
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Jan 2021 — Jul 2024 [monthly]
Completed PHASE1_PHASE2
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Mar 2020 — Jan 2021 [monthly]
Completed PHASE1_PHASE2
▶ Show 4 earlier versions
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Apr 2019 — Mar 2020 [monthly]
Completed PHASE1_PHASE2
Status: Unknown Status → Completed
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Jun 2018 — Apr 2019 [monthly]
Unknown Status PHASE1_PHASE2
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Feb 2017 — Jun 2018 [monthly]
Unknown Status PHASE1_PHASE2
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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
- National Cancer Institute (NCI)
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
For direct contact, visit the study record on ClinicalTrials.gov .