NCT01126138

Capecitabine (NX) Versus Docetaxel Plus Capecitabine (TX) as 1-line Chemotherapy on Metastatic Breast Cancer (MBC)

A Randomized Phase III Study to Investigate the Efficacy and Safety of Docetaxel + Capecitabine vs. Vinorelbine + Capecitabine Followed by Capecitabine Alone as 1st Therapy on Locally Advanced and Metastatic Breast Cancer Patients.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Chinese Academy of Medical Sciences · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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), Vinorelbine 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

Conditions

• Carcinoma, Invasive Ductal, Breast

Interventions

Type	Name	Description
DRUG	Vinorelbine plus Capecitabine for 6 cycles, followed by Capecitabine	Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14) Vinorelbine: 25 mg/m2 IV over 3 hours on day 1 and 8, every 3 weeks 21 days as one cycle and 6 cycles are required
DRUG	Docetaxel plus Capecitabine for 6 cycles, followed by Capecitabine	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 cycles are required. Followed by Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14) 21 days as one cycle until progression or unacceptable toxicity

Timeline

• Start date: 2010-07-01
• Primary completion: 2015-05-01
• Completion: 2015-08-01
• First posted: 2010-05-19
• Last updated: 2011-05-04

Locations

1 site across 1 country: China