Radiation Therapy, Cyclophosphamide, and Doxorubicin in Treating Women With Stage I or Stage II Breast Cancer Who Have Undergone Surgery
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cyclophosphamide and doxorubicin after surgery may kill any tumor cells that remain.
PURPOSE: This phase I/II trial is studying the side effects of radiation therapy when given together with cyclophosphamide and doxorubicin and to see how well they work in treating women with stage I or stage II breast cancer who have undergone surgery.
Drug: doxorubicin hydrochloride
Procedure: adjuvant therapy
Radiation: radiation therapy
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase I/II Partial Breast Irradiation With Concurrent Chemotherapy|
- Potential acute, late skin, and subcutaneous toxicity [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
- Local control rate [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Cosmetic effects [ Time Frame: 1 year ] [ Designated as safety issue: No ]
|Study Start Date:||July 2004|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
chemotherapyDrug: doxorubicin hydrochloride
chemotherapyProcedure: adjuvant therapy
chemotherapyRadiation: radiation therapy
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00278109
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Study Chair:||Richard C. Zellars, MD||Sidney Kimmel Comprehensive Cancer Center|