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A Multicenter Phase II Study, to Evaluate the Predictive Markers of Response in Locally Advanced Breast Cancer, Treated With Bevacizumab Combined With Neoadjuvant Chemotherapy

Phase 2
18 Years
70 Years
Open (Enrolling)
Breast Neoplasms

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Trial Information

A Multicenter Phase II Study, to Evaluate the Predictive Markers of Response in Locally Advanced Breast Cancer, Treated With Bevacizumab Combined With Neoadjuvant Chemotherapy

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.

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

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

- 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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Evaluation of SNPs genotyping.

Outcome Description:

The analysis of genetic differences will be determined through analysis of single nucleotide polymorphisms. It will be assesed before starting the treatment using Affymetrix's Human Mapping 500k array set.

Outcome Time Frame:

This evaluation will be performed within 14 days before start of treatment

Safety Issue:


Principal Investigator

Antonio Anton, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hospital Miguel Servet


Spain: Spanish Agency of Medicines

Study ID:




Start Date:

October 2009

Completion Date:

August 2012

Related Keywords:

  • Breast Neoplasms
  • breast
  • cancer
  • Pharmacogenomics
  • bevacizumab
  • Breast Neoplasms
  • Neoplasms