Breast Cancer Clinical Trial
Official title:
An EORTC-IDBBC/ECSG Phase II Study Evaluating The Role Of The Multi-Drug Resistance (MDR) Reversor, R101933, In Patients With Taxane Refractory Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Combining
R101933 with paclitaxel or docetaxel may reduce resistance to the drug and allow the tumor
cells to be killed.
PURPOSE: Phase II trial to study the effectiveness of combining R101933 with either
paclitaxel or docetaxel in treating patients who have metastatic breast cancer that has not
responded to previous chemotherapy.
OBJECTIVES:
- Determine the activity of R101933 in combination with paclitaxel or docetaxel in terms
of response to treatment and level of clinical benefit in patients with
taxane-refractory metastatic breast cancer.
- Determine the safety of this regimen in these patients.
- Determine the acute side effects in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive R101933 IV over 1 hour immediately followed by paclitaxel IV over 3 hours
or docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for 7 courses in the
absence of disease progression or unacceptable toxicity. Patients who have no disease
progression after 7 courses may continue with treatment at the investigator's discretion.
Patients are followed every 6 weeks until disease progression.
PROJECTED ACCRUAL: A total of 12-35 patients will be accrued for this study.
;
Primary Purpose: Treatment
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