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Angiogenesis Inhibitor

Bevacizumab for Breast Cancer

Phase 3

Waitlist Available

Led By Hope S Rugo

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologic confirmation of invasive cancer of the breast

Stage IV disease or stage IIIC disease (using American Joint Committee on Cancer [AJCC] criteria, 6th edition) not amenable to local therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing different chemotherapy regimens with or without bevacizumab to see which is more effective in treating patients with stage IIIC or stage IV breast cancer.

Eligible Conditions

Breast Cancer
No change needed.
HER2 Positive
Progesterone Receptor Positive

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression Free Survival

Secondary outcome measures

12 Month Progression Free Survival

Objective Tumor Response Rate

Overall Survival

+1 more

Side effects data

From 2015 Phase 4 trial • 45 Patients • NCT02036424

22%

vitreous hemorrhage

17%

worsening of cataract

posterior capsule opacification

vitreous syneresis

cranial nerve VI palsy

bradycardia

pneumonia

pyelonephritis

colon cancer

100%

80%

60%

40%

20%

Study treatment Arm

Bevacizumab

Ozurdex

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm C (Ixabepilone)Experimental Treatment4 Interventions

Patients receive ixabepilone IV over 60 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15. (closed to accrual as of 7/18/11)

Group II: Arm B (Nab-paclitaxel)Experimental Treatment4 Interventions

Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Patients may also receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15.

Group III: Arm A (Paclitaxel)Active Control4 Interventions

Patients receive 90 mg/m^2 paclitaxel IV over 1 hour on days 1, 8, and 15. Patients may receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5280

Ixabepilone

2006

Completed Phase 3

~2270