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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011037-27 | EudraCT Number |
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| Name | Class |
|---|---|
| Roche Farma, S.A | INDUSTRY |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab, docetaxel and doxorubicin followed by surgery | Other | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of SNPs genotyping. | 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. | This evaluation will be performed within 14 days before start of treatment |
| Assessment of tumoral response by Dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) | 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). | This evaluation will be performed within 14 days before start of treatment (baseline assesment). |
| Assessment of tumoral response by Dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) | 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). | This evaluation will be performed within 12-19 days after first cycle |
| Assessment of tumoral response by Dynamic contrast enhanced-magnetic resonance imaging (DCE-MRI) | 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). | This evaluation will be performed within 12-19 days aftet fifth cycle. |
| Positron emission tomography (PET) scan | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Complete pathological response in surgical piece | 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. | This evaluation will be performed within 20-22 weeks after start of treatment. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Obispo Polanco | Teruel | Aragon | 44002 | Spain | ||
| Hospital Miguel Servet |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| D000077143 | Docetaxel |
| D004317 | Doxorubicin |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| This evaluation will be performed within 14 days before start of treatment (baseline assesment) |
| Positron emission tomography (PET) scan | 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 | This evaluation will be performed within 12-19 days after first cycle |
| Positron emission tomography (PET) scan | 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 | This evaluation will be performed within 12-19 days aftet fifth cycle |
| Evaluation of Genomic tissular profile in a sample of biopsy | 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 | This evaluation will be performed within 14 days before start of treatment (baseline assesment |
| Evaluation of Genomic tissular profile in a sample of biopsy | 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 | This evaluation will be performed within 12-19 days after first cycle |
| Evaluation of Genomic tissular profile in a sample of biopsy | 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). | This evaluation will be performed within 12-19 days aftet fifth cycle |
| Evaluation of Proteomic expression in blood serum | To determine the proteomic expression in blood serum, a ZeptoMARK Reverse Array assay will be performed according to manufacturer's instructions. | This evaluation will be performed within 14 days before start of treatment (baseline assesment) |
| Evaluation of Proteomic expression in blood serum | To determine the proteomic expression in blood serum, a ZeptoMARK Reverse Array assay will be performed according to manufacturer's instructions. | This evaluation will be performed within 12-19 days after first cycle. Description: |
| Evaluation of Proteomic expression in blood serum | To determine the proteomic expression in blood serum, a ZeptoMARK Reverse Array assay will be performed according to manufacturer's instructions. | This evaluation will be performed within 12-19 days aftet fifth cycle. |
| 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 | Principal Investigator |
| Zaragoza |
| Aragon |
| 50009 |
| Spain |
| Hospital General Yagüe | Burgos | Burgos | 09005 | Spain |
| Hospital Universitario Marqués de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital de Donosti | San Sebastián | Guipúzcoa | 20014 | Spain |
| Onkologikoa | San Sebastián | Guipúzcoa | 20014 | Spain |
| Hospital de San Millan | Logroño | La Rioja | 26006 | Spain |
| Clinica Universitaria de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital de Navarra | Pamplona | Navarre | 31008 | Spain |
| Hospital de Tudela | Tudela | Navarre | 31500 | Spain |
| Hospital de Basurto | Bilbao | Vizcaya | 48013 | Spain |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |