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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: November 15, 2007
Last updated: May 4, 2016
Last verified: May 2016
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: FEC Drug: Paclitaxel Drug: bevacizumab [Avastin] Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Masking: None (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:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Rate of pathological complete response [ Time Frame: Event driven ]

Secondary Outcome Measures:
  • Objective response rate, disease-free interval, overall survival, rate of breast conservative surgery. [ Time Frame: Event driven ]
  • AEs, laboratory parameters [ Time Frame: Throughout study ]

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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00559845

Napoli, Campania, Italy, 80131
Reggio Emilia, Emilia-Romagna, Italy, 42100
Pordenone, Friuli-Venezia Giulia, Italy, 33170
Genova, Liguria, Italy, 16132
Mantova, Lombardia, Italy, 46100
Cuneo, Piemonte, Italy, 12100
Torino, Piemonte, Italy, 10126
Negrar, Veneto, Italy, 37024
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT00559845     History of Changes
Other Study ID Numbers: ML19884
Study First Received: November 15, 2007
Last Updated: May 4, 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents processed this record on September 18, 2017