Study Comparing Concomitant Docetaxel + Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine

This is an open, multicenter, two-armed Phase III study

Patients will be randomized to either of the following two arms:

Arm A (concomitant arm), Gemcitabine 1000 mglm2 will be administered intravenously on Days 1 and 8, repeated on Day 22. Docetaxel 75 mg/m2 will be given on Day 8 (before Gemcitabine), repeated on Day 22. This 3-week schedule defines a cycle of treatment for this arm. Overall 8 cycles will be administered.

Arm B (sequential arm) four cycles of Docetaxel 100 mg/m2 an Day 1, repeated an Day 22, followed by four cycles of Gemcitabine 1250 mg/m2 an a Day 1 and 8, repeated an Day 22, will be given. Both drugs will be administered in a 3-week schedule.

Bimonthly follow-up for patients without confirmed disease progression until progression of disease. Long-term follow-up for patients with confirmed disease progression will be done in 4 intervals.

For therapy control frequent blood chemistry and hematology, physical examination, weight control, potential adverse events and imaging procedures (CT, X-ray, MRI, Bone scan) am foreseen.

Inclusion criteria

• Patients with histologic or cytologic diagnosis of breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.
• Females, 18 to 75 years of age
• pre-treated with ONE anthracyclines containing chemotherapy either in neoadjuvant/adjuvant or 1st line metastatic setting will be enrolled into the study
• Patients with clinically measurable lesions will be enrolled in this study. Measurability is determined according to RECIST criteria
• Performance status of 70 or higher on the Karnofsky Performance Scale
• Adequate bone marrow reserve
• Adequate liver function
• Adequate renal function
• Informed consent form patient or guardian
• Childbearing potential either terminated by surgery, radiation, or menopause, use of an approved contraceptive method

Exclusion criteria

• Active infection (at the discretion of the investigator).
• Known or suspected brain metastases requiring steroid or radiation treatment.
• Pregnancy (recent negative urine pregnancy test for pre-menopausal patients mandatory)
• Breast-feeding
• Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator).
• Second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin).
• Bone metastases, pleural effusion, or ascites as the only site of disease.
• Bone marrow transplantation or autologous stern cell infusion following high-dose chemotherapy for adjuvant or metastatic disease.