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

Conditions

• Carcinoma, Invasive Ductal, Breast

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Vinorelbine plus Capecitabine for 6 cycles, followed by Capecitabine — DRUG
  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
• Docetaxel plus Capecitabine for 6 cycles, followed by Capecitabine — DRUG
  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

Study Details

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.

Key Dates

Start date

Jul 31, 2010

Status verified

May 2010

Primary completion

May 31, 2015

Completion

Aug 31, 2015

Study Design

Enrollment

200 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Other: Arm A
  Vinorelbine plus Capecitabine
• Other: Arm B
  Docetaxel plus Capecitabine

Primary Outcome Measure

Progression free survival(PFS) [ Time Frame: Up to 2 years until disease progression or death ]