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A Study of Avastin (Bevacizumab) in Patients With Inflammatory or Locally Advanced Breast Cancer.

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00559845
First received: November 15, 2007
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

This single arm study will assess the efficacy and safety of sequential neoadjuvant chemotherapy and Avastin, before surgery and/or radiotherapy, in patients with inflammatory or locally advanced operable breast cancer. Patients will receive FEC, followed by paclitaxel, given concomitantly with Avastin (10mg/kg i.v. every 2 weeks). The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.


Condition Intervention Phase
Breast Cancer
 Drug: bevacizumab [Avastin]
Drug: FEC
Drug: Paclitaxel
 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: An Open Label Neoadjuvant Study to Assess the Effect of Avastin on Tumor Response in Patients With Inflammatory or Locally Advanced Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Rate of pathological complete response [ Time Frame: Event driven ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rate, disease-free interval, overall survival, rate of breast conservative surgery. [ Time Frame: Event driven ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 57
Study Start Date: February 2008
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: bevacizumab [Avastin]
10mg/kg iv every 2 weeks
Drug: FEC
As prescribed
Drug: Paclitaxel
As prescribed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • female patients, >=18 years of age;
  • stage III, or inflammatory breast cancer;
  • ER/PgR positive or negative and HER-2 negative;
  • normal LVEF.

Exclusion Criteria:

  • previous chemotherapy/endocrine therapy;
  • evidence of distant metastatic disease;
  • other primary tumors in last 5 years (except for adequately treated cancer in situ of the cervix, or basal cell skin cancer);
  • chronic daily treatment with >325mg/day aspirin, or >75mg/day clopidogrel.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559845

Locations
Italy
Cuneo, Italy, 12100
Genova, Italy, 16132
Mantova, Italy, 46100
Napoli, Italy, 80131
Negrar, Italy, 37024
Pordenone, Italy, 33170
Reggio Emilia, Italy, 42100
Torino, Italy, 10126
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00559845     History of Changes
Other Study ID Numbers: ML19884
Study First Received: November 15, 2007
Last Updated: May 7, 2013
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Bevacizumab
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 19, 2013