Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Albumin-Bound Paclitaxel; Antibodies; Antibodies, Monoclonal; Cyclophosphamide; Dexrazoxane; Doxorubicin; Liposomal doxorubicin; Paclitaxel; Razoxane; Tamoxifen; Trastuzumab

Criteria

Inclusion Criteria:

• 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)

• No other currently active malignancy except nonmelanoma skin cancer

• Not pregnant or nursing

• Fertile patients must use effective contraception

• Patients taking tamoxifen must use effective nonhormonal contraception during and for 2 months after study

• No prior chemotherapy

• No other concurrent chemotherapy

• No more than 4 weeks of prior tamoxifen for disease

• Prior tamoxifen or raloxifene for longer than 4 weeks as chemoprevention allowed

• No concurrent tamoxifen or raloxifene

• No other concurrent hormonal therapy except for steroids for adrenal failure, hormones for non-disease-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic

• See Disease Characteristics

• No prior radiotherapy for index malignancy

• No prior radiotherapy to the ipsilateral breast, regional nodes, mediastinum, or heart

• Prior radiotherapy to the contralateral breast for ductal carcinoma in situ or early stage invasive breast cancer allowed provided earlier radiotherapy does not preclude optimal delivery of study radiotherapy and criterion of low risk for metastasis from first malignancy is met

• See Disease Characteristics

• No prior sentinel lymph node biopsy