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NX vs TX as 1-line Chemotherapy on MBC

2014-08-27 03:13:35 | BioPortfolio

Summary

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.

Description

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

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Histologically or Cytologically Confirmed Breast Cancer With Unresectable Locally Advanced and/or Metastatic Disease

Intervention

Vinorbine plus Capecitabine for 6 cycles, followed by Capecitabine, Docetaxel plus Capecitabine for 6 cycles, followed by Capecitabine

Location

Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing
China
100021

Status

Not yet recruiting

Source

Chinese Academy of Medical Sciences

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:35-0400

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Medical and Biotech [MESH] Definitions

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

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.

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A genus of fungi in the phylum BLASTOCLADIOMYCOTA. They exhibit complex life cycles and are parasitic on the larvae of MOSQUITOES.

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