A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00576901
First received: December 18, 2007
Last updated: October 7, 2013
Last verified: October 2013

December 18, 2007
October 7, 2013
November 2007
June 2009   (final data collection date for primary outcome measure)
Pathological response rate [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Pathological response rate.
Complete list of historical versions of study NCT00576901 on ClinicalTrials.gov Archive Site
  • Clinical response rate, breast-conservative surgery rate, disease-free survival. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters. [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
Efficacy: Clinical response rate, breast-conservative surgery rate, disease-free survival. Safety: AEs, lab parameters.
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer.
"An Open Label Study to Assess the Effect of Neoadjuvant Treatment With Docetaxel + Xeloda + Avastin on Pathological Response Rate in Inflammatory or Locally Advanced Breast Cancer"

This single arm study will assess the efficacy and safety of combination first-line treatment with docetaxel + Xeloda + Avastin in patients with inflammatory or locally advanced breast cancer. Patients will receive 3-weekly cycles of Avastin (15mg/kg i.v. on day 1 of each cycle), docetaxel (75mg/m2 i.v. on day 1 of each cycle, after Avastin) and Xeloda (2000mg/m2 p.o. on days 1-15 of each cycle). Four cycles of chemotherapy are planned, plus an optional additional two cycles; after chemotherapy patients will be assessed for surgery. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.

Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: bevacizumab [Avastin]
    15mg/kg iv on day 1 of each 3 week cycle
  • Drug: Docetaxel
    75mg/m2 iv on day 1 of each 3 week cycle
  • Drug: Xeloda
    2000mg/m2 po on days 1-15 of each 3 week cycle
Experimental: 1
Interventions:
  • Drug: bevacizumab [Avastin]
  • Drug: Docetaxel
  • Drug: Xeloda
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
June 2009
June 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • female patients, >=18 years of age;
  • HER2-negative, locally advanced (stage II or III) or inflammatory cancer of the breast;
  • ECOG performance status 0-1.

Exclusion Criteria:

  • metastatic disease (stage IV);
  • previous treatment for breast cancer;
  • evidence of CNS metastasis;
  • current or recent (within 10 days of first dose of Avastin) use of aspirin (>325mg/day) NSAIDs or full dose anticoagulants for therapeutic purposes;
  • clinically significant cardiovascular disease.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00576901
ML20561
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2013

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