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Cohort Study of Prospective Validation of Predictive Factors and Biological Imaging of Response to Bevacizumab and Paclitaxel in Patients With Metastatic Breast Cancer

NCT01745757 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 510

Last updated 2023-01-27

No results posted yet for this study

Summary

Bevacizumab plus chemotherapy improves response rates and prolongs PFS when used as first- and second-line therapy for advanced breast cancer. However, bevacizumab has not improved OS in the individual studies currently reported. In Europe, EMA has maintained its indication associated with weekly paclitaxel in first line metastatic breast cancer and more recently with capecitabine based on RIBBON 1 trial's results.

The identification of patient subsets that receive the most clinical benefit would enable more specific treatment administration of bevacizumab and allow patients unlikely to benefit the opportunity to seek other treatment modalities. Unfortunately, despite efforts to identify patient subsets with a differential benefit from bevacizumab, no validated biomarkers have been defined.

The Avastin cohort is a unique opportunity to investigate various biological and imaging parameters which could be related to clinical benefit of the combination of bevacizumab and weekly paclitaxel in first line metastatic breast cancer in a homogeneously treated population in French cancer centers. This trial will gather the expertise of several translational research platforms of different cancer centers from the UNICANCER consortium.

Conditions

Interventions

DRUG

Bevacizumab

Treatments received by patients in this study are prescribed in the context of standard care

DRUG

paclitaxel

Treatments received by patients in this study are prescribed in the context of standard care

Sponsors & Collaborators

  • UNICANCER

    lead OTHER

Principal Investigators

  • Jean-Yves PIERGA, MD, PhD · Institut Curie Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2022-06-30
Completion
2022-12-31

Countries

  • France

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01745757 on ClinicalTrials.gov