A Randomized Phase III Study Comparing Concomitant Docetaxel Plus Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine in Anthracycline-Pretreated Metastatic or Locally Recurrent Breast Cancer Patients
18 Years
75 Years
Female
Breast Cancer
Trial Information
A Randomized Phase III Study Comparing Concomitant Docetaxel Plus Gemcitabine to Sequential Therapy of Docetaxel Followed by Gemcitabine in Anthracycline-Pretreated Metastatic or Locally Recurrent Breast Cancer Patients
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
to compare the Time To Disease Progression between those patients with unresectable, locally recurrent or metastatic breast cancer who are treated with concomitant Docetaxel plus Gemcitabine to those patients treated with sequential therapy of Doc
Principal Investigator
Christoph Wiltschke, Prof
Investigator Role:
Principal Investigator
Investigator Affiliation:
Univ. Klinik f. Innere Medizin I
Authority:
Austria: Federal Ministry for Health and Women
Study ID:
CECOG/BC 1.3.002
NCT ID:
NCT00294385
Start Date:
June 2002
Completion Date:
October 2005
Related Keywords:
- Breast Cancer
- Breast Cancer
- Docetaxel
- Breast Neoplasms
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