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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00559845
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : May 5, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: FEC Drug: Paclitaxel Drug: bevacizumab [Avastin] Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
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
Study Start Date : February 2008
Primary Completion Date : July 2015
Study Completion Date : July 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Bevacizumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1 Drug: FEC
As prescribed
Drug: Paclitaxel
As prescribed
Drug: bevacizumab [Avastin]
10mg/kg iv every 2 weeks



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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559845


Locations
Italy
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00559845     History of Changes
Other Study ID Numbers: ML19884
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: May 5, 2016
Last Verified: May 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents