Study to Evaluate Markers of Response in Locally Advanced Breast Cancer (IMAGING)
This study is ongoing, but not recruiting participants.
Sponsor:
Clinica Universidad de Navarra, Universidad de Navarra
Collaborator:
Roche Farma, S.A
Information provided by (Responsible Party):
Clinica Universidad de Navarra, Universidad de Navarra
ClinicalTrials.gov Identifier:
NCT01338753
First received: March 4, 2011
Last updated: June 7, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Neoplasms |
Other: Bevacizumab, docetaxel and doxorubicin followed by surgery |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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 |
Resource links provided by NLM:
Further study details as provided by Clinica Universidad de Navarra, Universidad de Navarra:
Primary Outcome Measures:
- Evaluation of SNPs genotyping. [ Time Frame: This evaluation will be performed within 14 days before start of treatment ] [ Designated as safety issue: No ]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.
- Assessment of tumoral response by Dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) [ Time Frame: This evaluation will be performed within 14 days before start of treatment (baseline assesment). ] [ Designated as safety issue: No ]The radiological interpretation of the images will evaluate size, shape, extent, distribution and kinetics of the lesons according to American College of Radiology Breast Imaging Reporting and Data System (ACR BIRADS- MRI (2003) guidelines).
- Assessment of tumoral response by Dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) [ Time Frame: This evaluation will be performed within 12-19 days after first cycle ] [ Designated as safety issue: No ]The radiological interpretation of the images will evaluate size, shape, extent, distribution and kinetics of the lesons according to American College of Radiology Breast Imaging Reporting and Data System (ACR BIRADS- MRI (2003) guidelines).
- Assessment of tumoral response by Dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) [ Time Frame: This evaluation will be performed within 12-19 days aftet fifth cycle. ] [ Designated as safety issue: No ]The radiological interpretation of the images will evaluate size, shape, extent, distribution and kinetics of the lesons according to American College of Radiology Breast Imaging Reporting and Data System (ACR BIRADS- MRI (2003) guidelines).
- Positron emission tomography (PET) scan [ Time Frame: This evaluation will be performed within 14 days before start of treatment (baseline assesment) ] [ Designated as safety issue: No ]It will be determined the association between tissue:blood activity ratio and hypoxic tumor volume by 18F-fluoromisonidazole positron emission tomography (FMISO-PET). DNA synthesis, assesed by [18F]-fluoro-3'-deoxy-3'-L-fluorothymidine PET (FLT-PET), will be compared to quantitative kinetics data adquired through previously described DCE-MRI. Finally, these results will be correlated with the Risk Score obtained in the genomic analysis
- Positron emission tomography (PET) scan [ Time Frame: This evaluation will be performed within 12-19 days after first cycle ] [ Designated as safety issue: No ]It will be determined the association between tissue:blood activity ratio and hypoxic tumor volume by 18F-fluoromisonidazole positron emission tomography (FMISO-PET). DNA synthesis, assesed by [18F]-fluoro-3'-deoxy-3'-L-fluorothymidine PET (FLT-PET), will be compared to quantitative kinetics data adquired through previously described DCE-MRI. Finally, these results will be correlated with the Risk Score obtained in the genomic analysis
- Positron emission tomography (PET) scan [ Time Frame: This evaluation will be performed within 12-19 days aftet fifth cycle ] [ Designated as safety issue: No ]It will be determined the association between tissue:blood activity ratio and hypoxic tumor volume by 18F-fluoromisonidazole positron emission tomography (FMISO-PET). DNA synthesis, assesed by [18F]-fluoro-3'-deoxy-3'-L-fluorothymidine PET (FLT-PET), will be compared to quantitative kinetics data adquired through previously described DCE-MRI. Finally, these results will be correlated with the Risk Score obtained in the genomic analysis
- Evaluation of Genomic tissular profile in a sample of biopsy [ Time Frame: This evaluation will be performed within 14 days before start of treatment (baseline assesment ] [ Designated as safety issue: No ]A correlative analysis will be performed between the expression profile of the sample obtained by Affymetrix 's GeneChip Human Genome U133 and its association with tumor response (based on the imaging markers described previously) on the proposed stages (baseline, before first cycle of treatment and after fifth cycle of treatment
- Evaluation of Genomic tissular profile in a sample of biopsy [ Time Frame: This evaluation will be performed within 12-19 days after first cycle ] [ Designated as safety issue: No ]A correlative analysis will be performed between the expression profile of the sample obtained by Affymetrix 's GeneChip Human Genome U133 and its association with tumor response (based on the imaging markers described previously) on the proposed stages (baseline, before first cycle of treatment and after fifth cycle of treatment
- Evaluation of Genomic tissular profile in a sample of biopsy [ Time Frame: This evaluation will be performed within 12-19 days aftet fifth cycle ] [ Designated as safety issue: No ]A correlative analysis will be performed between the expression profile of the sample obtained by Affymetrix 's GeneChip Human Genome U133 and its association with tumor response (based on the imaging markers described previously) on the proposed stages (baseline, before first cycle of treatment and after fifth cycle of treatment).
- Evaluation of Proteomic expression in blood serum [ Time Frame: This evaluation will be performed within 14 days before start of treatment (baseline assesment) ] [ Designated as safety issue: No ]To determine the proteomic expression in blood serum, a ZeptoMARK Reverse Array assay will be performed according to manufacturer's instructions.
- Evaluation of Proteomic expression in blood serum [ Time Frame: This evaluation will be performed within 12-19 days after first cycle. Description: ] [ Designated as safety issue: No ]To determine the proteomic expression in blood serum, a ZeptoMARK Reverse Array assay will be performed according to manufacturer's instructions.
- Evaluation of Proteomic expression in blood serum [ Time Frame: This evaluation will be performed within 12-19 days aftet fifth cycle. ] [ Designated as safety issue: No ]To determine the proteomic expression in blood serum, a ZeptoMARK Reverse Array assay will be performed according to manufacturer's instructions.
Secondary Outcome Measures:
- Evaluation of Complete pathological response in surgical piece [ Time Frame: This evaluation will be performed within 20-22 weeks after start of treatment. ] [ Designated as safety issue: No ]To determine if a patient has undergone complete pathological response, an anatomo-pathological study will be conducted on the surgical piece. The evaluation will follow the Miller and Payne criteria; a complete response will be considered just in the absence of invasive tumor cells in breast and lymphatic nodules.
| Enrollment: | 74 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Other: Bevacizumab, docetaxel and doxorubicin followed by surgery
- Avastin
- Taxotere
- Adriamycin
The dosage form is Parenteral Injection (I/V) for all study drugs. Bevacizumab 15mg/kg in a single dose on day 1. Then 3 weeks later begin the cycles. On the day 1 of the cycle the patient receives Bevacizumab 15mg/kg, docetaxel 60mg/m2 and doxorubicin 50mg/m2.
The cycles have a frequency of one every three weeks, and the protocol defines 4 cycles in total.
The surgical procedure will be done 4-6 weeks after completion of chemotherapy.
Other Names:
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| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01338753
Locations
| Spain | |
| Hospital Obispo Polanco | |
| Teruel, Aragón, Spain, 44002 | |
| Hospital Miguel Servet | |
| Zaragoza, Aragón, Spain, 50009 | |
| Hospital Universitario Marqués de Valdecilla | |
| Santander, Cantabria, Spain, 39008 | |
| Onkologikoa | |
| San Sebastián, Guipúzcoa, Spain, 20014 | |
| Hospital de Donosti | |
| San Sebastián, Guipúzcoa, Spain, 20014 | |
| Hospital de San Millan | |
| Logroño, La Rioja, Spain, 26006 | |
| Hospital de Navarra | |
| Pamplona, Navarra, Spain, 31008 | |
| Clinica Universitaria de Navarra | |
| Pamplona, Navarra, Spain, 31008 | |
| Hospital de Tudela | |
| Tudela, Navarra, Spain, 31500 | |
| Hospital de Basurto | |
| Bilbao, Vizcaya, Spain, 48013 | |
| Hospital General Yagüe | |
| Burgos, Spain, 09005 | |
Sponsors and Collaborators
Clinica Universidad de Navarra, Universidad de Navarra
Roche Farma, S.A
Investigators
| Principal Investigator: | Antonio Anton, MD | Hospital Miguel Servet |
| Principal Investigator: | Jesus Garcia-Foncillas, MD | Clinica Universitaria de Navarra |
| Principal Investigator: | Alfonso Yubero, MD | Hospital Obispo Polanco |
| Principal Investigator: | Isabel Alvarez, MD | Hospital Donosti |
| Principal Investigator: | Jose Manuel Lopez-Vega, MD | Hospital Universitario Marqués de Valdecilla |
| Principal Investigator: | Blanca Hernando, MD | Hospital General Yagüe |
| Principal Investigator: | Jose Juan Illarramendi, Md | Hospital de Navarra |
| Principal Investigator: | Irene Gil, MD | Hospital de Tudela |
| Principal Investigator: | Purificacion Martinez del Prado, MD | Hospital de Basurto |
| Principal Investigator: | Rosa Sanchez, MD | Complejo Hospitalario San Millán San Pedro De La Rioja |
| Principal Investigator: | Arrate Plazaola, MD | Onkologikoa |
| Principal Investigator: | Serafin Morales, MD | Hospital Universitario Arnau Vilanova de Lleida |
More Information
No publications provided
| Responsible Party: | Clinica Universidad de Navarra, Universidad de Navarra |
| ClinicalTrials.gov Identifier: | NCT01338753 History of Changes |
| Other Study ID Numbers: | ML22197/2009-01, 2009-011037-27 |
| Study First Received: | March 4, 2011 |
| Last Updated: | June 7, 2012 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Clinica Universidad de Navarra, Universidad de Navarra:
|
breast cancer Pharmacogenomics bevacizumab |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Doxorubicin Docetaxel Bevacizumab Antibiotics, Antineoplastic |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013