Clinical trial · Observational
Polymorphism Interaction to Predict Bevacizumab Efficacy
Polymorphism Interaction to Predict Bevacizumab Efficacy in Advanced Breast Cancer Patients: an Exploratory Retrospective Analysis
- 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)
Although many attempts have been done to identify vascular endothelial growth factor-A (VEGF-A) single nucleotide polymorphisms (SNPs) correlated with bevacizumab response, in advanced cancer patients, the results are still inconclusive. We will conduct a pharmacogenetic study to assess, in a population of metastatic breast cancer (MBC) patients, the possible predictive role of VEGF-A, VEGF receptor-2 (VEGFR-2), interleukin-8 (IL-8), hypoxia inducible factor-1α (HIF-1α), hypoxia inducible factor-2α (HIF-2α) and thrombospondin-1 (TSP-1) SNPs for bevacizumab response when combined with first-line paclitaxel and for progression free survival (PFS). Analyses will be performed on germline DNA obtained from blood samples and SNPs will be investigated by real-time polymerase chain reaction (PCR) technique. The multifactor dimensionality reduction (MDR) methodology will be applied to investigate the interaction between SNPs.
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Chemotherapy
- description
- MBC patients treated with a first-line chemotherapy including paclitaxel without bevacizumab
- label
- bevacizumab+chemotherapy
- description
- histologically confirmed HER2-negative MBC, treated with a first-line therapy including bevacizumab 10 mg/m2 i.v. on days 1 and 15 combined with first-line paclitaxel 90 mg/m2 i.v. on days 1, 8 and 15, every 4 weeks
Primary outcomes (1)
- measure
- progression-free survival
- timeFrame
- 24 months
- description
- progression-free survival in an unselected population of metastatic breast cancer patients treated with bevacizumab combined with first-line paclitaxel assessed through the multifactor dimensionality reduction methodology
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * diagnosis histologically confirmed of metastatic breast cancer * age (from 18 to 90 years) * Eastern Cooperative Oncology Group (ECOG) performance status (0 or 1-2) * hormonal-receptor status (positive or negative) * previous adjuvant chemotherapy (none, anthracycline or anthracycline plus taxane) * previous hormonal therapy (adjuvant or metastatic)disease-free interval from the first diagnosis of breast cancer (≤ or \>12 months) * extent of disease (≤ or \>3 sites) * location of disease (viscera or bone) * disease evaluation (measurable or non-measurable)and bevacizumab maintenance (yes or no). Exclusion Criteria: * Patients with human epidermal growth factor receptor type 2 (HER2)-positive
References
Publications (6)
- BACKGROUNDMiller K, Wang M, Gralow J, Dickler M, Cobleigh M, Perez EA, Shenkier T, Cella D, Davidson NE. Paclitaxel plus bevacizumab versus paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007 Dec 27;357(26):2666-76. doi: 10.1056/NEJMoa072113. PMID 18160686
- BACKGROUNDMiles DW, Chan A, Dirix LY, Cortes J, Pivot X, Tomczak P, Delozier T, Sohn JH, Provencher L, Puglisi F, Harbeck N, Steger GG, Schneeweiss A, Wardley AM, Chlistalla A, Romieu G. Phase III study of bevacizumab plus docetaxel compared with placebo plus docetaxel for the first-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2010 Jul 10;28(20):3239-47. doi: 10.1200/JCO.2008.21.6457. Epub 2010 May 24. PMID 20498403
- BACKGROUNDSchneider BP, Wang M, Radovich M, Sledge GW, Badve S, Thor A, Flockhart DA, Hancock B, Davidson N, Gralow J, Dickler M, Perez EA, Cobleigh M, Shenkier T, Edgerton S, Miller KD; ECOG 2100. Association of vascular endothelial growth factor and vascular endothelial growth factor receptor-2 genetic polymorphisms with outcome in a trial of paclitaxel compared with paclitaxel plus bevacizumab in advanced breast cancer: ECOG 2100. J Clin Oncol. 2008 Oct 1;26(28):4672-8. doi: 10.1200/JCO.2008.16.1612. PMID 18824714
- BACKGROUNDPander J, Wessels JAM, Gelderblom H, van der Straaten T, Punt CJA, Guchelaar HJ. Pharmacogenetic interaction analysis for the efficacy of systemic treatment in metastatic colorectal cancer. Ann Oncol. 2011 May;22(5):1147-1153. doi: 10.1093/annonc/mdq572. Epub 2010 Nov 3. PMID 21048041
- DERIVEDColtelli L, Orlandi P, Finale C, Musettini G, Masini LC, Scalese M, Soria G, Sartori E, Nodari Y, Arrighi G, Bandini A, Banchi M, Tacchi C, Tang D, Salvadori B, Tanganelli L, Giovannelli S, Pistelli M, Cupini S, Lucchesi M, Cosimi A, Lorenzini G, Biasco E, Caparello C, Acconci G, Fontana E, Bona E, Farnesi A, Pellino A, Marini A, De Maio E, Stasi I, Barbara C, Sammarco E, Rosada J, Allegrini G, Bocci G. Bevacizumab and Paclitaxel in Advanced, Hormone Receptor-Positive Breast Cancer: Multifactor Dimensionality Reduction Methodology to Identify Best Overall Survival. Oncol Res. 2026 Apr 22;34(5):13. doi: 10.32604/or.2026.073799. eCollection 2026.