Clinical trial NCT01338753: Study to Evaluate Markers of Response in Locally Advanced Breast Cancer
Official title: A Multicenter Phase II Study, to Evaluate the Predictive Markers of Response in Locally Advanced Breast Cancer, Treated With Bevacizumab Combined With Neoadjuvant Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Neoplasms
Keywords: breast
cancer
Pharmacogenomics
bevacizumab
Lead sponsor: Clinica Universidad de Navarra, Universidad de Navarra
Sponsor class: OTHER
Collaborators: name: Roche Farma, S.A
First posted: 2011-04-19
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of SNPs genotyping.
timeFrame: This evaluation will be performed within 14 days before start of treatment
measure: Assessment of tumoral response by Dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI)
timeFrame: This evaluation will be performed within 14 days before start of treatment (baseline assesment).
measure: Assessment of tumoral response by Dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI)
timeFrame: This evaluation will be performed within 12-19 days after first cycle
measure: Assessment of tumoral response by Dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI)
timeFrame: This evaluation will be performed within 12-19 days aftet fifth cycle.
measure: Positron emission tomography (PET) scan
timeFrame: This evaluation will be performed within 14 days before start of treatment (baseline assesment)
measure: Positron emission tomography (PET) scan
timeFrame: This evaluation will be performed within 12-19 days after first cycle
measure: Positron emission tomography (PET) scan
timeFrame: This evaluation will be performed within 12-19 days aftet fifth cycle
measure: Evaluation of Genomic tissular profile in a sample of biopsy
timeFrame: This evaluation will be performed within 14 days before start of treatment (baseline assesment
measure: Evaluation of Genomic tissular profile in a sample of biopsy
timeFrame: This evaluation will be performed within 12-19 days after first cycle
measure: Evaluation of Genomic tissular profile in a sample of biopsy
timeFrame: This evaluation will be performed within 12-19 days aftet fifth cycle
measure: Evaluation of Proteomic expression in blood serum
timeFrame: This evaluation will be performed within 14 days before start of treatment (baseline assesment)
measure: Evaluation of Proteomic expression in blood serum
timeFrame: This evaluation will be performed within 12-19 days after first cycle. Description:
measure: Evaluation of Proteomic expression in blood serum
timeFrame: This evaluation will be performed within 12-19 days aftet fifth cycle.
Secondary outcomes:
measure: Evaluation of Complete pathological response in surgical piece
timeFrame: This evaluation will be performed within 20-22 weeks after start of treatment.
Other outcomes:
Locations:
city: Teruel
country: Spain
facility: Hospital Obispo Polanco
state: Aragón
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
state: Aragón
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: San Sebastián
country: Spain
facility: Hospital de Donosti
state: Guipúzcoa
city: San Sebastián
country: Spain
facility: Onkologikoa
state: Guipúzcoa
city: Logroño
country: Spain
facility: Hospital de San Millan
state: La Rioja
city: Pamplona
country: Spain
facility: Clinica Universitaria de Navarra
state: Navarra
city: Pamplona
country: Spain
facility: Hospital de Navarra
state: Navarra
city: Tudela
country: Spain
facility: Hospital de Tudela
state: Navarra
city: Bilbao
country: Spain
facility: Hospital de Basurto
state: Vizcaya
city: Burgos
country: Spain
facility: Hospital General Yagüe
Study officials:
affiliation: Hospital Miguel Servet
name: Antonio Anton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinica Universitaria de Navarra
name: Jesus Garcia-Foncillas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Obispo Polanco
name: Alfonso Yubero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Donosti
name: Isabel Alvarez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Marqués de Valdecilla
name: Jose Manuel Lopez-Vega, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Yagüe
name: Blanca Hernando, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Navarra
name: Jose Juan Illarramendi, Md
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Tudela
name: Irene Gil, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Basurto
name: Purificacion Martinez del Prado, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Complejo Hospitalario San Millán San Pedro De La Rioja
name: Rosa Sanchez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Onkologikoa
name: Arrate Plazaola, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Arnau Vilanova de Lleida
name: Serafin Morales, MD
role: PRINCIPAL_INVESTIGATOR
References: