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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

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ClinicalTrials.gov Identifier: NCT00964704
Recruitment Status : Withdrawn (No patients have been recruited therefore study has been cancelled)
First Posted : August 25, 2009
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

August 21, 2009
August 25, 2009
November 2, 2016
March 2011
August 2013   (Final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00964704 on ClinicalTrials.gov Archive Site
  • Safety and tolerability: AEs, laboratory parameters, LVEF [ Time Frame: throughout study, laboratory parameters every 3 weeks, LVEF every 12 weeks ]
  • Overall Response Rate, Best Overall Response, Duration of Response, Progression-free Survival (first-line), Overall Survival [ Time Frame: event-driven, tumour assessment every 6 weeks for 24 weeks, every 12 weeks thereafter ]
Same as current
Not Provided
Not Provided
 
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
A Single Arm, Open-label Study to Evaluate the Efficacy on Tumor Response and the Safety of Bevacizumab and Trastuzumab Combination and Sequential Capecitabine in Patients With HER2 +Ive Locally Recurrent or Metastatic Breast Cancer After Early Relapse to Adjuvant Trastuzumab-containing Therapy
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.
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Drug: bevacizumab [Avastin]
    15mg/kg iv every 3 weeks
  • Drug: capecitabine [Xeloda]
    added at time of disease-progression, 1000mg/m2 bid po days 1-14 of every 3-week cycle
  • Drug: docetaxel
    background therapy at time of disease progression, 100mg/m2 iv every 3 weeks
  • Drug: trastuzumab [Herceptin]
    8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg every 3 weeks
Experimental: Single Arm
Interventions:
  • Drug: bevacizumab [Avastin]
  • Drug: capecitabine [Xeloda]
  • Drug: docetaxel
  • Drug: trastuzumab [Herceptin]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
55
August 2013
August 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • male or female patients, age >/=18 years
  • locally recurrent or metastatic HER2-positive breast cancer
  • disease progression during or up to 12 months after prior adjuvant therapy with trastuzumab
  • LVEF >/=55% at baseline

Exclusion Criteria:

  • prior treatment with bevacizumab or capecitabine
  • anthracyclines in prior adjuvant or neoadjuvant treatment exceeding cumulative dose of 360mg/m2 for doxorubicin and 720mg/kg for epirubicin
  • chronic daily treatment with corticosteroids (>10mg/day methylprednisolone equivalent; excluding inhaled corticosteroids), or aspirin (>325mg/day), or clopidogrel (>75mg/day)
  • clinically significant cardiac disease, or cardiac toxicity during previous trastuzumab therapy
  • evidence of spinal cord compression or CNS metastasis
  • history of other malignancy, unless disease-free for >/=5 years or treated curatively for carcinoma in situ of the cervix or non-melanomatous skin cancer
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Austria
 
NCT00964704
ML22056
2008-007495-20
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP