Official Title: “A Multimodality Treatment Approach to Patients With Inflammatory Cancer of the Breast and Locally Advanced Non-Inflammatory Stage III Breast Cancer and Stage IV Breast Cancer”

This study is designed to evaluate the efficacy of high dose melphalan and autologous bone marrow transplantation given as consolidation therapy to patients with inflammatory or metastatic carcinoma of the breast in complete remission. All patients entered will receive induction therapy with cyclophosphamide, adriamycin, methotrexate and 5-fluorouracil with hormonal synchronization utilizing tamoxifen and premarin as in a previous Medicine Branch protocol (MB-160C). Among patients with inflammatory carcinoma of the breast, pathologic complete responders will receive irradiation to the breast and regional lymph nodes; convertible partial responders and clinical complete responders with residual disease on biopsy will undergo surgical resection of bulk disease followed by irradiation of the chest wall and regional lymph nodes excluding the axilla. Both groups of responders will be randomized to receive either systemic consolidation therapy with high dose melphalan (180 mg/M2 total dose over 3 days) and autologous bone marrow transplantation followed by maintenance therapy or maintenance therapy alone. Complete responders in this noninflammatory group will not receive further therapy since, historically, they have done well following induction and local therapy, with maintenance therapy alone.

Patients with metastatic breast cancer will be assessed for response throughout induction therapy. Complete and convertable partial responders will receive consolidative therapy and be randomized to ABMT followed by 6 months of maintenance therapy vs. maintenance alone.

Study Type: Interventional

Study Design: Treatment, Safety/Efficacy Study

This study is designed to evaluate the efficacy of high dose melphalan and autologous bone marrow transplantation given as consolidation therapy to patients with inflammatory or metastatic carcinoma of the breast in complete remission. All patients entered will receive induction therapy with cyclophosphamide, adriamycin, methotrexate and 5-fluorouracil with hormonal synchronization utilizing tamoxifen and premarin as in a previous Medicine Branch protocol (MB-160C). Among patients with inflammatory carcinoma of the breast, pathologic complete responders will receive irradiation to the breast and regional lymph nodes; convertible partial responders and clinical complete responders with residual disease on biopsy will undergo surgical resection of bulk disease followed by irradiation of the chest wall and regional lymph nodes excluding the axilla. Both groups of responders will be randomized to receive either systemic consolidation therapy with high dose melphalan (180 mg/M2 total dose over 3 days) and autologous bone marrow transplantation followed by maintenance therapy or maintenance therapy alone. Complete responders in this noninflammatory group will not receive further therapy since, historically, they have done well following induction and local therapy, with maintenance therapy alone.

Patients with metastatic breast cancer will be assessed for response throughout induction therapy. Complete and convertable partial responders will receive consolidative therapy and be randomized to ABMT followed by 6 months of maintenance therapy vs. maintenance alone.

Intervention(s) in this Clinical Trial

• Procedure: high dose melphalan and autologous bone marrow transplantation

• Patients must have a histologically documented diagnosis of mammary carcinoma and evaluable disease in the breast.
• Diagnostic tissue must be reviewed at NIH.
• All ICB patients must meet Haagensen's clinical criteria of ICB.
• Patients with metastatic breast cancer must have evaluable disease.
• There must be no history of prior cytotoxic therapy.
• There must be no history of previous malignancy except for cured nonmelanoma skin cancer and cervical carcinoma in situ.
• Performance status (Karnofsky scale) must be greater than 30 for patients with metastatic breast cancer.
• Staging workup must be negative for distant metastases in Stage III patients.
• WBC count greater than 4000 per mm(3) and platelet count greater than 100,000 per mm(3).
• Normal hepatic and renal function, unless due to tumor involvement.
• Patients must be willing to give informed consent and be geographically accessible for follow up.
• No history of other malignant neoplasms except for curatively treated nonmelanoma skin cancer or surgically cured carcinoma of the cervix in situ.
• Patients must not be poor medical or psychiatric risks because of non-malignant systemic disease which would preclude them being subjected to any of the treatments in this protocol.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: National Cancer Institute (NCI)

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00001193

Study ID Number: 840216

ClinicalTrials.gov Identifier: NCT00001193

Health Authority: United States: Federal Government