A Study of Herceptin (Trastuzumab) in Combination With Avastin (Bevacizumab) and Sequential Xeloda (Capecitabine) or Docetaxel in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer

Sponsor
Hoffmann-La Roche
Study ID
NCT00964704
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bevacizumab [Avastin] — DRUG
    15mg/kg iv every 3 weeks
  • capecitabine [Xeloda] — DRUG
    added at time of disease-progression, 1000mg/m2 bid po days 1-14 of every 3-week cycle
  • docetaxel — DRUG
    background therapy at time of disease progression, 100mg/m2 iv every 3 weeks
  • trastuzumab [Herceptin] — DRUG
    8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg every 3 weeks

Study Details

This single arm, open-label study will evaluate the safety and efficacy of Herceptin in combination with Avastin and sequential Xeloda in patients with locally recurrent or metastatic HER2-positive breast cancer after early relapse on adjuvant Herceptin therapy. Patients will receive Herceptin at a loading dose of 8mg/kg iv followed by 6mg/kg iv every three weeks, and Avastin 15mg/kg every 3 weeks. At first sign of disease progression Xeloda 1000mg/m2 bid po will be added on days 1-14 of each cycle, or docetaxel (100mg/m2 iv every 3 weeks) if Xeloda is not indicated for a patient. Anticipated time on study treatment is until disease-progression on second line treatment and target sample size is \<100.

Key Dates

First listed
Aug 25, 2009
Start date
Mar 31, 2011
Status verified
Nov 2016
Primary completion
Aug 31, 2013
Completion
Aug 31, 2013

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single Arm

Primary Outcome Measure

Progression-Free Survival on second-line treatment [ Time Frame: event-driven, tumour assessments every 6 weeks for 24 weeks, every 12 weeks thereafter ]

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