NCT02329639

Brief Summary

Metastatic Breast cancer (MBC) patients from ten Italian Divisions of Medical Oncology, with 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, will be enrolled for the present pharmacogenetic study. MBC patients treated with first-line chemotherapy including paclitaxel without bevacizumab will be also enrolled as control group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2014

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 31, 2014

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

11.5 years

First QC Date

December 29, 2014

Last Update Submit

April 28, 2026

Conditions

Metastatic Breast Cancer

Keywords

bevacizumabpaclitaxelpharmacogeneticsbreast cancer

Outcome Measures

Primary Outcomes (1)

  • Progression free survival

    progression free survival in an unselected population of metastatic breast cancer patients treated with first-line paclitaxel and bevacizumab or with chemotherapy alone, assessed through the multifactor dimensionality reduction methodology (genetic interaction analysis)

    24 months

Secondary Outcomes (1)

  • Overall survival

    24 months

Study Arms (2)

case group

genetic interaction analysis of women with HER2 negative metastatic breast cancer performing a first-line chemotherapy with bevacizumab

Genetic: genetic interaction analysis

control group

genetic interaction analysis of women with HER2 negative metastatic breast cancer performing a first-line chemotherapy without bevacizumab

Genetic: genetic interaction analysis

Interventions

genetic interaction analysisGENETIC

VEGFR-2 rs11133360/IL-8 rs4073 genetic interaction analysis

case groupcontrol group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

MBC patients treated with a first-line chemotherapy including paclitaxel with or without bevacizumab

You may qualify if:

  • 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, will be enrolled for the present pharmacogenetic study. MBC patients treated with a first-line chemotherapy without bevacizumab will also be enrolled as control goup.

You may not qualify if:

  • histologically not confirmed HER2-negative MBC, and patients not treated with a first-line chemotherapy with or without bevacizumab.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Clinical and Experimental Medicine, University of Pisa

Pisa, I Am Not in the U.S. Or Canada, 56125, Italy

Location

Azienda USL 5 of Pisa

Pontedera, Pisa, 56025, Italy

Location

Related Publications (1)

  • Allegrini G, Coltelli L, Orlandi P, Fontana A, Camerini A, Ferro A, Cazzaniga M, Casadei V, Lucchesi S, Bona E, Di Lieto M, Pazzagli I, Villa F, Amoroso D, Scalese M, Arrighi G, Molinaro S, Fioravanti A, Finale C, Triolo R, Di Desidero T, Donati S, Marcucci L, Goletti O, Del Re M, Salvadori B, Ferrarini I, Danesi R, Falcone A, Bocci G. Pharmacogenetic interaction analysis of VEGFR-2 and IL-8 polymorphisms in advanced breast cancer patients treated with paclitaxel and bevacizumab. Pharmacogenomics. 2014 Dec;15(16):1985-99. doi: 10.2217/pgs.14.140.

    PMID: 25521357BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Guido Bocci, MD, PhD

    Dept. of Clinical and Experimental Medicine, University of Pisa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD,PhD

Study Record Dates

First Submitted

December 29, 2014

First Posted

December 31, 2014

Study Start

April 1, 2014

Primary Completion

October 1, 2025

Study Completion

April 1, 2026

Last Updated

May 5, 2026

Record last verified: 2026-04

Locations

IT(2)