Clinical trial · Interventional
Study to Evaluate Markers of Response in Locally Advanced Breast Cancer
A Multicenter Phase II Study, to Evaluate the Predictive Markers of Response in Locally Advanced Breast Cancer, Treated With Bevacizumab Combined With Neoadjuvant Chemotherapy
NCT01338753CI-TRIAL-00012042IMAGINGcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab, docetaxel and doxorubicin followed by surgery | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (13)
- measure
- Evaluation of SNPs genotyping.
- timeFrame
- This evaluation will be performed within 14 days before start of treatment
- 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.
- 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).
- description
- 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).
- 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
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.