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Alkylating agents

Chemotherapy +/− Bevacizumab for Breast Cancer

Phase 3

Waitlist Available

Led By Kathy D Miller

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

Patients with human epidermal growth factor receptor (HER)2 + (3+ by immunohistochemistry [IHC] or fluorescent in situ hybridization [FISH] ratio >= 2) breast cancer are not eligible

Patients must have histologically confirmed adenocarcinoma of the breast at significant risk of distant recurrence based on at least one of the following criteria:

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed at 3 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing doxorubicin hydrochloride, cyclophosphamide, and paclitaxel with or without bevacizumab to see how well they work in treating patients with lymph node-positive or high-risk, lymph node-negative breast cancer.

Who is the study for?

This trial is for adults with breast cancer that has spread to lymph nodes or is at high risk of returning. They must have had surgery between 28-84 days before starting treatment, be in good physical condition (ECOG 0-1), and have normal blood counts and organ function tests. People with HER2+ breast cancer, recent major surgeries, uncontrolled heart conditions, bleeding disorders, or who are pregnant can't join.

What is being tested?

The study compares the effectiveness of chemotherapy drugs doxorubicin hydrochloride, cyclophosphamide, and paclitaxel with or without the antibody bevacizumab in patients after surgery. Bevacizumab may block tumor blood supply. The goal is to see which combination better prevents cancer from coming back.

What are the potential side effects?

Possible side effects include nausea, hair loss from chemotherapy drugs; high blood pressure, bleeding risks from bevacizumab; fatigue; increased infection risk due to immune system suppression; and potential heart damage from doxorubicin.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is not HER2 positive as determined by specific tests.

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My breast cancer is at high risk of spreading.

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I have completed surgery for breast cancer, including removal of the breast or part of it and checking the lymph nodes.

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My breast surgery removed all visible cancer; LCIS at the margins is okay.

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I am fully active or can carry out light work.

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I do not have serious heart or brain blood vessel problems.

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I do not have any bleeding disorders.

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I do not have any non-healing wounds, fractures, or recent serious abdominal issues.

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I am not allergic to paclitaxel or certain drug ingredients.

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I will receive focused breast radiation after chemotherapy.

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I have had a stroke, TIA, or bleeding in my brain.

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I have heart failure that affects my daily activities.

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I have had a blockage in the arteries supplying my intestines.

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I have unstable chest pain.

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I haven't had any major surgery in the last 28 days, except for a biopsy or device placement.

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I had breast-saving surgery and will receive radiation as specified by my doctor.

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My blood clotting time is normal on my current blood thinner medication.

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I have moderate to severe blockage in my arteries.

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I will receive radiation to the entire breast after chemotherapy.

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I do not have signs of inflammation or immovable lumps under my arm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assessed at 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assessed at 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed at 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Invasive Disease-free Survival (IDFS) Rate at 5 Years

Secondary study objectives

5-year Overall Survival (OS)

The Association Between IDFS and Genotype

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm III (chemotherapy, bevacizumab monotherapy)Experimental Treatment6 Interventions

Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm I and bevacizumab as in arm II. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm I and bevacizumab as in arm II. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses. Beginning 2 months later, patients then receive bevacizumab IV over 30-90 minutes on day 1. Treatment with bevacizumab alone repeats every 3 weeks for 10 courses.

Group II: Arm II (chemotherapy, bevacizumab)Experimental Treatment6 Interventions

Patients receive doxorubicin hydrochloride and cyclophosphamide as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel as in arm I and bevacizumab IV over 30-90 minutes on day 1. Treatment with paclitaxel and bevacizumab repeats every 3 weeks for 4 courses.

Group III: Arm I (chemotherapy, placebo)Active Control6 Interventions

Patients receive doxorubicin hydrochloride IV, cyclophosphamide IV over 20-30 minutes, and placebo IV over 30-90 minutes on day 1. Treatment repeats every 2 or 3 weeks for 4 courses. Beginning 3 weeks later, patients then receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo IV over 30-90 minutes on day 1. Treatment with paclitaxel and placebo repeats every 3 weeks for 4 courses.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bevacizumab

2013

Completed Phase 4

~5540

Cyclophosphamide

2010

Completed Phase 4

~2310