Study to Evaluate Markers of Response in Locally Advanced Breast Cancer (IMAGING)

University of Navarra

Status and phase

Completed

Phase 2

Conditions

Breast Neoplasms

Treatments

Other: Bevacizumab, docetaxel and doxorubicin followed by surgery

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01338753

ML22197/2009-01

2009-011037-27 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to compare the association between image and certain molecular markers with complete response in patients with locally advanced breast cancer, treated with neoadjuvant chemotherapy composed of Bevacizumab, Docetaxel and Doxorubicin.

Full description

This is a pharmacogenomic phase II, multicenter, prospective clinical trial whose main objective is to evaluate the association of molecular and imaging markers with the response to bevacizumab administration in combination with docetaxel and doxorubicin as neoadjuvant chemotherapy in patients diagnose with locally advanced breast cancer.

Enrollment

74 patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female
Signed Informed consent form
Ages between 18 and 70
12 months of life expectancy at least
Histologically confirmed breast cancer
No previous treatment for locally advanced breast cancer
Her2+ o Her2-
Disease measurable by PET and/or MRI
ECOG 0-1
Adequate organic function
Negative pregnancy test; fertile women must use anticonceptive methods after ICF and 30 days after last study drug administration
Enough capability to follow the procedures and follow-up test included in the protocol

Exclusion criteria

Metastatic disease
Inadequate health to receive the study chemotherapy
Previous breast cancer treatment
Pregnant or lactating women
Major surgery or significative traumatic injure in the 28 days previous to inclusion, or during treatment.
Minor surgery 24 hours before first bevacizumab infusion
Concomitant or recent aspirin(>325mg/day)or clopidogrel(>75mg/day) treatment
Concomitant or recent oral anticoagulant treatment
History or evidence or bleeding diathesis or hereditary coagulopathy with bleeding risk
Uncontrolled arterial hypertension
Clinical significative heart disease, or uncontrolled severe arrhythmia disorder
Unhealed wounds, peptic ulcer or bone fracture
History of abdominal fistula, gastrointestinal perforation or intrabdominal abscess, 6 months before inclusion
Evidence of any other disease, neurological or metabolical disorder or physical examination or laboratory finding related with any disease that makes the subjet ineligible for the study treatment or that put the subject in risk because of the study treatment.
Psychiatric disorders that may prevent the subject to complete the study treatment
Current participation in any other trial involving an investigational drug, or participation in any kind of trial 28 days before inclusion
Chronical corticosteroid treatment
Hypersensitivity reaction to bevacizumab or any of its components or any of the other study drugs or components
Patients diagnosed with different neoplasms the previous 5 years excluding non melanoma skin cancer and resected cervical cancer