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Table 1 Main inclusion and exclusion criteria for entry in the study

From: Randomised phase 3 open-label trial of first-line treatment with gemcitabine in association with docetaxel or paclitaxel in women with metastatic breast cancer: a comparison of different schedules and treatments

Inclusion criteria Exclusion criteria
Adult women with HER-2 negative MBC Previous chemotherapy for metastatic disease
MBC relapsed after receiving one adjuvant/neoadjuvant chemotherapy containing an anthracycline, unless clinically contraindicated Previous chemotherapy with gemcitabine in any setting of disease
Could have received a prior neoadjuvant or adjuvant taxanes regimen as long as it was ≥12 months since completion of the treatment Patients with second primary malignancy (except in situ carcinoma of the cervix or adequately treated non-melanoma carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
Measurable disease as defined by RECIST 1.0 (however patients with only bone metastases were included in the study), Pre-existing sensorial or motor neuropathy NCI-CTC grade >1
Previous hormonal therapy for adjuvant setting or metastatic disease (≤2 lines), or immunotherapy, was allowed and should have been completed before the enrolment Inflammatory breast cancer without evidence of metastatic disease
Performance status ≥70 on the Karnofsky Scale Patients with serious concomitant systemic disorders (e.g., uncontrolled active cardiovascular diseases and/or myocardial infarction within the preceding 6 months)
Life expectancy ≥12 weeks Patients with clinical evidence of symptomatic brain metastasis
Adequate bone marrow and liver/renal function Pregnancy or breast-feeding
Prior radiotherapy should have been completed 4 weeks before study entry Patients with reproductive potential not using an approved contraceptive method if appropriate (except hormonal substitutive therapy)
  1. HER-2: Human Epidermal Growth Factor Receptor 2, MBC: Metastatic Breast Cancer, NCI-CTC: National Cancer Institute-Common Toxicity Criteria, RECIST: Response Evaluation Criteria in Solid Tumours.