Phase I/II Partial Breast Irradiation With Concurrent Chemotherapy
39 Years
N/A
Female
Breast Cancer
Trial Information
Phase I/II Partial Breast Irradiation With Concurrent Chemotherapy
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the breast by routine hematoxylin and
eosin (H&E) staining
- Primary tumor ≤ 4 cm and 0-3 positive axillary lymph nodes (pathologic T1-2,
pathologic N0-N1, M0)
- Patients with lymph nodes positive only by cytokeratin staining (i.e., H&E
negative) are eligible
- No squamous cell carcinoma or sarcoma of the breast
- Patients must have undergone a segmental mastectomy (SM) with a level I and ll
axillary dissection or sentinel lymph node biopsy within the past 14 weeks
- Surgical margins at the time of SM must be negative (> 3 mm) for both invasive
carcinoma and for non-invasive ductal carcinoma
- No active local-regional disease
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Sex: female
- Menopausal status not specified
- Not pregnant
- Negative pregnancy test
- Fertile patients must use effective non-hormonal contraception
- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or carcinoma in situ of the cervix
- No other serious or poorly controlled medical or psychiatric condition that could be
exacerbated by, or complicate compliance with study treatment
PRIOR CONCURRENT THERAPY:
- No prior radiation therapy to the breast
- No prior trastuzumab (Herceptin ®)
- No other concurrent chemotherapy
- No concurrent hormonal therapy except the following:
- Steroids given for adrenal failure
- Hormones administered for non-disease-related conditions (e.g., insulin for
diabetes, synthroid for hypothyroidism)
- Intermittent dexamethasone as an antiemetic or premedication
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Potential acute, late skin, and subcutaneous toxicity
Outcome Time Frame:
1 year
Safety Issue:
Yes
Principal Investigator
Richard C. Zellars, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Sidney Kimmel Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
J0381 CDR0000446085
NCT ID:
NCT00278109
Start Date:
July 2004
Completion Date:
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
