Spots Global Cancer Trial Database for Chemotherapy in Treating Patients With Breast Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Chemotherapy in Treating Patients With Breast Cancer

Official Title: Phase I/II Clinical and Pharmacological Study of Liposomal Annamycin in Anthracycline-Resistant Breast Cancer

Study ID: NCT00012129

Conditions

Breast Cancer

Interventions

liposomal annamycin

Study Description

Brief Summary: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase I/II trial to study the effectiveness of annamycin liposomal in treating patients who have locally advanced or metastatic breast cancer that has not responded to previous chemotherapy.

Detailed Description: OBJECTIVES: I. Determine the observed anti-tumor activity of annamycin liposomal in patients with anthracycline-resistant locally advanced or metastatic breast cancer. II. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients. III. Determine the clinical pharmacology of this regimen in these patients. IV. Determine the rationale for the dose and chosen schedule of this regimen in these patients. OUTLINE: Patients receive annamycin liposomal IV over 60 minutes on day 1. Treatment continues every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 14-30 patients will be accrued for this study within 7-30 months.