Chemotherapy and Progenitor Cell Transplantation to Treat Inflammatory Breast Cancer

Launched by NATIONAL CANCER INSTITUTE (NCI) · Nov 3, 1999

Keywords

ClinConnect Summary

BACKGROUND:

Efforts to cure high-risk breast cancer have increasingly focused on the application of dose intensive chemotherapy. To date, the use of dose intensive and high-dose chemotherapy has not significantly changed the survival for the majority of high risk and metastatic patients. The optimal schedule and combination of agents to improve the results of high-dose chemotherapy is not known. This study will pilot a combination of chemotherapy agents for the treatment of Inflammatory Breast Cancer.

OBJECTIVES:

To define, in a statistically relevant manner, the clinical efficacy of thi...

Gender

ALL

Eligibility criteria

• * ELIGIBILITY CRITERIA:
• INCLUSION CRITERIA:
• • Age greater or equal to 18 years.
• • All patients must have a histologically confirmed diagnosis of Inflammatory Breast Carcinoma stage III B. Patients with no clinical inflammatory signs but with tumor invasion of dermal lymphatic on histology are eligible. Patients with metastatic disease and Inflammatory Breast Carcinoma are not eligible. All pathologic material must be reviewed and confirmed by the Department of Pathology of the treating institution prior to treatment (there will be no central pathology review).
• • Patients may be untreated or may have received prior induction chemotherapy outside the NCI. If patients received prior induction chemotherapy, they may not have been unresponsive to it. They may have received chemotherapy either before (neo-adjuvant setting) or after local surgery (adjuvant setting).
• • Karnofsky performance status of greater than 70% (ECOG 0 or 1).
• • Ejection fraction by MUGA or 2-D echocardiogram within institution normal limits.
• • Creatinine clearance of greater than 60 cc/mm.
• • AST and ALT less than 3 times the upper limit of normal.
• • Bilirubin less than 1.5 (except in cases of Gilbert's disease).
• • ANC greater than l000/mm(3).
• • Platelet count greater than 90,000/mm(3).
• • DLCO greater than 50%.
• • No history of medical or psychiatric disease which would preclude safe treatment in the view of the principal investigator.
• • No history of abnormal bleeding tendency or predisposition to repeated infections.
• • Patients must be able to give informed consent.
• EXCLUSION CRITERIA:
• • Patients with Inflammatory Breast Cancer but with metastatic disease.
• • Any patient may be excluded from this study at the discretion of the principal investigator if it is deemed that allowing participation would represent an unacceptable medical or psychiatric risk.
• • Any patient with a need for chronic steroids or anticoagulation will be ineligible.
• • Any patient testing positive for HIV (AIDS) or hepatitis B or C will be ineligible.
• • Any female patient known or found to be pregnant will be considered ineligible. Patients of childbearing potential unwilling to practice contraception will be ineligible.
• • Any patient with an active second malignancy (excluding treated skin cancers or carcinoma in situ) will be ineligible.

Trial Officials