Status:
COMPLETED
Study Comparing Concomitant Docetaxel + Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine
Lead Sponsor:
Central European Cooperative Oncology Group
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the Time To Disease Progression (TTDP) between those patients with unresectable, locally recurrent or metastatic breast cancer who are treated with concomitant ...
Detailed Description
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 intraven...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2005
Estimated Enrollment :
430 Patients enrolled
Trial Details
Trial ID
NCT00294385
Start Date
June 1 2002
End Date
October 1 2005
Last Update
June 23 2011
Active Locations (18)
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1
2. Med. Abteilung - LKH-Steyr
Steyr, Austria, 4400
2
Hanusch KrankenhausHämatologisch-Onkologisches Zentrum
Vienna, Austria, 1140
3
Intere IV Krankenhaus Wels
Wels, Austria, 4600
4
Cancer Center Plovdiv
Plovdiv, Bulgaria, 4000