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It is a phase III trial to explore the efficacy and safety of vinorelbine plus capecitabine (NX) and docetaxel plus capecitabine (TX) as first line treatment followed by capecitabine alone till Progressive Disease(PD). We plan to enroll 200 pts for limited budget and the non-inferior trend of the two curves is anticipated.
We designed the randomized non-inferiority study. Main Inclusion& exclusion Criteria include: 1) Histologically or cytologically confirmed breast cancer with unresectable locally advanced and/or metastatic disease; 2) Untreated patients with unresectable locally advanced and/or metastatic disease; 3) with at least 1 lesion measurable by radiological method(RECIST criteria); 4) Karnofsky Performance Status(KPS)≥70; 5) normal Adequate hepatic, renal, and bone marrow function; 6) Life expectancy of at least 12 weeks; 7) No previous chemotherapy for metastatic breast cancer. Primary endpoint is Progression free survival(PFS), second endpoint are safety profiles (National Cancer Institute-Common Toxicity Criteria 3.0, NCI-CTC 3.0), overall survival and response rate. During Primary study treatment, Arm A: Capecitabine: 1,000 mg/m2 per ora(PO) twice daily (day 1-14), Vinorbine 25 mg/m2 intravenous(IV) over 3 hours on day 1 and 8, every 3 weeks, 21 days as one cycle and 6-8 cycles are required; Arm B: Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14), Docetaxel 75 mg/m2 IV over 3 hours on day 1, every 3 weeks, 21 days as one cycle and 6-8 cycles are required. Patients who are responding (complete or partial), or whose disease is stable followed by Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14) 21 days as one cycle until progression or unacceptable toxicity
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Histologically or Cytologically Confirmed Breast Cancer With Unresectable Locally Advanced and/or Metastatic Disease
Vinorbine plus Capecitabine for 6 cycles, followed by Capecitabine, Docetaxel plus Capecitabine for 6 cycles, followed by Capecitabine
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Not yet recruiting
Chinese Academy of Medical Sciences
Published on BioPortfolio: 2014-08-27T03:13:35-0400
Docetaxel Followed by CEF (Cyclophosphamide, Epirubicin and 5-Fluorouracil) Compared to Docetaxel and Capecitabine Followed by CEX (Cyclophosphamide, Epirubicin and Capecitabine) as Adjuvant Treatment for Breast Cancer
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Bouts of physical irritability or movement alternating with periods of quiescence. It includes biochemical activity and hormonal activity which may be cellular. These cycles are shorter than 24 hours and include sleep-wakefulness cycles and the periodic activation of the digestive system.
A dimension of auditory sensation varying with cycles per second of the sound stimulus.
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In a clinical trial or interventional study, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or change...
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