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A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT02005549
First received: December 4, 2013
Last updated: June 30, 2014
Last verified: May 2014

December 4, 2013
June 30, 2014
February 2006
April 2008   (final data collection date for primary outcome measure)
Percentage of Participants With Pathological Complete Response (pCR) [ Time Frame: Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18]) ] [ Designated as safety issue: No ]
pCR was defined as the absence of signs for invasive tumor in the final surgical sample as judged by the local pathologist. Surgery was performed 2 to 4 weeks after the last chemotherapy cycle.
Pathological complete response rate [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT02005549 on ClinicalTrials.gov Archive Site
  • Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR) [ Time Frame: Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18]) ] [ Designated as safety issue: No ]
    Percentage of participants with pCR plus the percentage of participants without pCR who achieved CR or PR as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<] 10 millimeters [mm]). No new lesions. PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
  • Percentage of Participants Undergoing Breast-Conserving Surgery [ Time Frame: 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18]) ] [ Designated as safety issue: No ]
    Percentage of participants undergoing a breast-conserving procedure versus a modified radical mastectomy at final surgery, performed 2 to 4 weeks after the last chemotherapy cycle (Week 18)
  • Clinical objective response rate [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • Rate of breast-conserving surgery [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of serious and specific adverse events [ Time Frame: approximately 1.5 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer
A Phase II Study of Bevacizumab With Docetaxel and Capecitabine in the Neoadjuvant Setting for Breast Cancer Patients

This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time on study treatment is 3-12 months.

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]
    15 mg/kg iv on Day 1 of each 3-week cycle, 5 cycles
  • Drug: docetaxel
    75 mg/m2 on Day 1 of each 3-week cycle, 6 cycles
  • Drug: capecitabine [Xeloda]
    950 mg/m2, orally twice daily, evening of Day 1 until morning of Day 15, followed by a 7 day rest period, every 3 weeks
Experimental: Neoadjuvant Therapy
Interventions:
  • Drug: bevacizumab [Avastin]
  • Drug: docetaxel
  • Drug: capecitabine [Xeloda]
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
18
April 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • female patients, 18-70years of age;
  • histologically-proven invasive breast cancer;
  • no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;
  • no distant disease/secondary cancer.

Exclusion Criteria:

  • pregnant or lactating women;
  • pre-operative local treatment for breast cancer;
  • prior or concurrent systemic antitumor therapy;
  • clinically significant cardiac disease.
Female
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT02005549
ML19869
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Chair: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
May 2014

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