Status:
COMPLETED
Partial Breast Irradiation With Chemotherapy
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
40+ years
Phase:
PHASE1
PHASE2
Brief Summary
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...
Detailed Description
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 cycl...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT00278109
Start Date
July 1 2004
End Date
December 1 2016
Last Update
February 19 2020
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410