Breast NeoplasmsPhase 2IMAGINGNCT01338753
Study to Evaluate Markers of Response in Locally Advanced Breast Cancer
A Phase 2 study testing Bevacizumab, docetaxel and doxorubicin followed by surgery in people with Breast Neoplasms, run by Clinica Universidad de Navarra, Universidad de Navarra at 11 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- Bevacizumab, docetaxel and doxorubicin followed by surgery
- Type of treatment
- Injection or infusion
- How many people
- 74 participants
- Where
- 11 sitesSpain
- Study dates
- Oct 2009to May 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Hospital de Basurto
Bilbao, Vizcaya, 48013
Hospital General Yagüe
Burgos, Burgos, 09005
Hospital de San Millan
Logroño, La Rioja, 26006
Clinica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital de Navarra
Pamplona, Navarre, 31008
Hospital de Donosti
San Sebastián, Guipúzcoa, 20014
Onkologikoa
San Sebastián, Guipúzcoa, 20014
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Obispo Polanco
Teruel, Aragon, 44002
Hospital de Tudela
Tudela, Navarre, 31500
Hospital Miguel Servet
Zaragoza, Aragon, 50009
About this study
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
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.
Read the 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.
- Conditions
- Breast Neoplasms
- Being tested
- Bevacizumab, docetaxel and doxorubicin followed by surgery
- Keywords
- breast, cancer, Pharmacogenomics, bevacizumab
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bevacizumab, docetaxel and doxorubicin followed by surgeryOther
Also called 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: This evaluation will be performed within 12-19 days aftet fifth cycle.
Secondary outcomes (1)
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.
Measured: This evaluation will be performed within 20-22 weeks after start of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startOct 2009
- Primary completionOct 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Farma, S.A
- Responsible party
- Sponsor
- Investigators
- Antonio Anton, MD, Principal investigator, Hospital Miguel ServetJesus Garcia-Foncillas, MD, Principal investigator, Clinica Universitaria de NavarraAlfonso Yubero, MD, Principal investigator, Hospital Obispo PolancoIsabel Alvarez, MD, Principal investigator, Hospital DonostiJose Manuel Lopez-Vega, MD, Principal investigator, Hospital Universitario Marqués de ValdecillaBlanca Hernando, MD, Principal investigator, Hospital General YagüeJose Juan Illarramendi, Md, Principal investigator, Hospital de NavarraIrene Gil, MD, Principal investigator, Hospital de Tudela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338753
- Sponsor's protocol ID
- ML22197/2009-01
- Other IDs
- 2009-011037-27, 2009
- Acronym
- IMAGING
- Status last verified
- Sep 2013
- First submitted
- 4 Mar 2011
- Last updated
- 10 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01338753
- Acronym / sponsor ID
- IMAGING / ML22197/2009-01
- Conditions
- Breast Neoplasms
- Keywords
- breast, cancer, Pharmacogenomics, bevacizumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Collaborators
- Roche Farma, S.A
- Study start
- Oct 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 19 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female
- Signed Informed consent form
- Ages between 18 and 70
- 12 months of life expectancy at least
- Histologically confirmed breast cancer
Key exclusion criteria (19 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bevacizumab, docetaxel and doxorubicin followed by surgeryAlso: Avastin, Taxotere, AdriamycinThe 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 | – |
Primary outcome
Evaluation of SNPs genotyping.
Time frame: This evaluation will be performed within 14 days before start of treatment
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).
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
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.
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)
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
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
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
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
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
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)
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:
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.
To determine the proteomic expression in blood serum, a ZeptoMARK Reverse Array assay will be performed according to manufacturer's instructions.
1 secondary outcome
Evaluation of Complete pathological response in surgical piece
Time frame: This evaluation will be performed within 20-22 weeks after start of treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Anton, MD principal investigator
Hospital Miguel Servet
Jesus Garcia-Foncillas, MD principal investigator
Clinica Universitaria de Navarra
Alfonso Yubero, MD principal investigator
Hospital Obispo Polanco
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bevacizumab, docetaxel and doxorubicin followed by surgery in people with Breast Neoplasms, run by Clinica Universidad de Navarra, Universidad de Navarra at 11 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of SNPs genotyping. (time frame: This evaluation will be performed within 14 days before start of treatment). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2013.