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Clinical Trials/EUCTR2005-005048-19-IT
EUCTR2005-005048-19-IT
Active, not recruiting
Not Applicable

A phase II randomised study to investigate the effects of Bevacizumab on cell proliferation and on pCR in patients with locally advanced operable breast cancer - ND

ISTITUTO EUROPEO DI ONCOLOGIA0 sites120 target enrollmentJanuary 31, 2006
DrugsAVASTIN

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
ISTITUTO EUROPEO DI ONCOLOGIA
Enrollment
120
Status
Active, not recruiting
Last Updated
14 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 31, 2006
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • Patients with histologically proven primary breast cancer 2\.0 cm, T2\-T3 T4 a\-d, N0\-2, M0 Women aged 18 70 years
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1\.2 Adults (18\-64 years) yes
  • F.1\.2\.1 Number of subjects for this age range
  • F.1\.3 Elderly (\>\=65 years) yes
  • F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • Patients with overexpression HER2/neu 3 or amplification of HER2/neu gene evaluated by FISH, suitable for Herceptin containing regimens as primary therapy Patients with other non\-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator. Specifically not eligible are patients with uncontrolled active infection, chronic infection such as active HBV or HCV INR greater than 1\.50\. Prior history of bleeding diathesis or coagulopathy including deep venous thrombosis or pulmonary embolism. Recent within last six months or current history of gastrointestinal bleeding.

Outcomes

Primary Outcomes

Not specified

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