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: February 3, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: bevacizumab [Avastin]
Drug: docetaxel
Drug: capecitabine [Xeloda]
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Bevacizumab With Docetaxel and Capecitabine in the Neoadjuvant Setting for Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Pathological complete response rate [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 18
Study Start Date: February 2006
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neoadjuvant Therapy 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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT02005549

Locations
Austria
Salzburg, Austria, 5020
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Chair: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02005549     History of Changes
Other Study ID Numbers: ML19869
Study First Received: December 4, 2013
Last Updated: February 3, 2014
Health Authority: Austria: Austrian Federal Office for Safety in Health Care

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Docetaxel
Capecitabine
Bevacizumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on April 17, 2014