A Biomarker Study in Patients With HER2-negative Metastatic Breast Cancer Treated With Bevacizumab and Paclitaxel

Sponsor
Theodoros Foukakis
Study ID
NCT01722968
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    15mg/kg administered iv every 3 weeks in combination with paclitaxel 80mg/m2 iv weekly
  • Paclitaxel — DRUG
    80mg/m2 iv weekly

Study Details

To explore molecular biomarkers and/or gene expression signatures that predict response to bevacizumab given in combination with paclitaxel as first line therapy in HER2 negative metastatic breast cancer (MBC).

Key Dates

First listed
Nov 7, 2012
Start date
Nov 30, 2012
Status verified
Feb 2019
Primary completion
Jun 30, 2018

Study Design

Enrollment
33 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm A
    Arm A and feasibility phase: Bevacizumab 15mg/kg administered iv every 3 weeks in combination with paclitaxel 80mg/m2 iv weekly.
  • Active Comparator: Arm B
    Arm B: Paclitaxel 80mg/m2 iv weekly.

Primary Outcome Measure

Identification of molecular biomarkers [ Time Frame: After the study completion,After completion of the study, which will take up to 3 years ]

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