Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer
Stopped early · Phase 3
Conditions studied: Cardiac Toxicity, Inflammatory Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IV Breast Cancer
In brief
Randomized phase III trial to compare the effectiveness of combination chemotherapy, surgery, and radiation therapy with or without dexrazoxane and trastuzumab in treating women who have stage IIIA, stage IIIB or stage IV breast cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dexrazoxane, may protect normal cells from the side effects of chemotherapy. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known if chemotherapy combined with surgery and radiation therapy is more effective with or without dexrazoxane and trastuzumab in treating breast cancer
Key facts
- Study ID
- NCT00016276
- Run by
- National Cancer Institute (NCI)
- People needed
- 396
- Starts
- 2001-05-01
- Last updated by the study team
- 2013-01-16
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed primary infiltrating adenocarcinoma of the breast
- Confirmed by core needle biopsy or incisional biopsy
- Amplification of HER-2 by FISH
- Overexpression (3+) of HER-2 by immunohistochemistry
- Staging criteria after complete clinical and radiographic staging:
- T3, N1, M0
- Any T, N2 or N3, M0
- T4, any N, M0, including clinical or pathological inflammatory disease
- Regional stage IV disease with supraclavicular or infraclavicular lymph nodes as only site of metastasis
- Measurable or evaluable disease
- Prior ductal carcinoma in situ of the ipsilateral breast allowed if treated with excision only without mastectomy or radiation
- Metaplastic carcinoma allowed
- Synchronous bilateral primary disease allowed (provided at least 1 cancer meets staging criteria)
- No dermal lymphatic involvement with clinical inflammatory changes
- Hormone receptor status:
- Estrogen receptor positive or negative
- Progesterone receptor positive or negative
- Female
- Granulocyte count at least 1,000/mm\^3
- Platelet count at least 100,000/mm\^3
- Bilirubin no greater than upper limit of normal (ULN)
- AST no greater than 2 times ULN
- Creatinine no greater than 1.5 times ULN
- LVEF normal by MUGA
- No uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension)
Where it is running
- Cancer and Leukemia Group B — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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