Multimodality Treatment for Women With Stage II, Stage III, or Stage IV Breast Cancer
Completed · Phase 2
Conditions studied: Breast Cancer
In brief
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy, monoclonal antibody therapy, and surgery may be a more effective treatment for breast cancer. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, monoclonal antibody therapy, and surgery in treating women who have stage II, stage III, or stage IV breast cancer.
Key facts
- Study ID
- NCT00006110
- Run by
- UNC Lineberger Comprehensive Cancer Center
- People needed
- 82
- Starts
- 1998-12-01
- Expected to finish
- 2013-04-01
- Last updated by the study team
- 2017-07-31
Who can join
Age: 1 and older, up to 120. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed stage IIB, IIIA, IIIB, IIIC, or previously untreated stage IV primary carcinoma of the breast
- Fine needle aspiration, core needle biopsy, or incisional biopsy allowed
- No excisional biopsy
- Any of the following:
- Tumor size 2, Nodes 1 (T2N1) or tumor size 3 nodes 0 (T3N0)
- Any T with N2 (including axillary lymph nodes matted to one another) or N3
- Any T4, including inflammatory breast cancer
- Adjuvant patients with at least 4 positive lymph nodes and HER-2 overexpressing tumor
- Supraclavicular or infraclavicular positive lymph nodes without distant metastases
- Distant metastases with measurable disease in breast or lymph nodes
- Synchronous bilateral primary breast cancer allowed if the more serious cancer meets entry criteria
- Measurable or evaluable disease
- PATIENT CHARACTERISTICS:
- Age: Not specified
- Sex: Female
- Menopausal status: Not specified
- Performance status: Not specified
- Life expectancy: Not specified
- Hematopoietic:
- White cell count > 3000 / mm3 Platelet count > 100,000 / mm3
- Hemoglobin > 9 mg / dl Bilirubin < 1.5 x normal Creatinine < 1.5 x normal left ventricular ejection fraction (LVEF) normal by resting nuclear ventriculogram Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception
- Exclusions
- Prior malignancies except:
- Effectively treated squamous cell or basal cell skin cancer Carcinoma in situ of the cervix that has been curatively treated by surgery alone Nonbreast malignancy from which patient has been disease-free for 5 years and is at low risk of recurrence
Where it is running
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill — Chapel Hill, North Carolina, United States
- Comprehensive Cancer Center at Wake Forest University — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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