Status:
COMPLETED
Trastuzumab and External Beam Radiation Therapy in Treating Women With Stage III or Stage IV Breast Cancer
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or...
Detailed Description
OBJECTIVES: Primary * Determine the tolerability of trastuzumab (Herceptin®) and concurrent external beam radiotherapy in women with HER2-overexpressing stage III or IV breast cancer. Secondary * ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed\* invasive primary carcinoma of the breast by fine-needle aspiration, core needle biopsy, or incisional biopsy
- Excisional biopsy is not allowed
- Stage III or IV disease (clinical and radiographic staging), including any of the following:
- Any T with N2 disease (metastasis to ipsilateral axillary lymph nodes fixed to one another or other structures) or N3 disease (metastasis to ipsilateral internal mammary lymph nodes)
- T4, any N disease
- Inflammatory disease
- Supraclavicular and/or infraclavicular adenopathy
- Distant metastasis with measurable disease in the breast or lymph nodes
- HER2-overexpressing tumor
- Measurable or evaluable disease
- Residual locoregional disease after completion of neoadjuvant chemotherapy OR locoregional recurrent disease
- Synchronous bilateral primary cancers allowed provided the more serious of the two cancers meets staging criteria
- Hormone receptor status not specified
- PATIENT CHARACTERISTICS:
- Menopausal status not specified
- WBC \> 2,000/mm\^3
- Platelet count \> 50,000/mm\^3
- Hemoglobin \> 11 g/dL
- Negative pregnancy test
- Fertile patients must use effective contraception
- Radionucleotide ventriculography/LVEF normal OR ≤ 10% asymptomatic decline from baseline after completion of neoadjuvant chemotherapy
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy to the breast or regional lymph nodes
- Concurrent participation in neoadjuvant chemotherapy clinical trials allowed
Exclusion
Key Trial Info
Start Date :
March 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2009
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00943410
Start Date
March 1 2000
End Date
July 1 2009
Last Update
August 15 2012
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