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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 not have received prior cytotoxic chemotherapy or hormonal therapy for this breast cancer; prior treatment with an anthracycline, anthracenedione or taxane for any condition is not allowed. NOTE: prior use of tamoxifen for chemoprevention is allowed but must be discontinued at study entry; similarly, prior raloxifene use is allowed but must be discontinued at study entry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed at 3 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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I haven't had chemotherapy or hormone therapy for my breast cancer, nor used certain cancer drugs before.
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I have cancer in both breasts, but the more advanced one qualifies for the trial.
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I have had a heart attack in the last 12 months.
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My breast cancer is at high risk of spreading.
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My breast cancer has spread to at least one of my underarm lymph nodes.
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My breast cancer is ER- and larger than 1 cm, or it's ER+ and meets specific size and score criteria.
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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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It's been 1 to 3 months since my last breast cancer surgery.
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I am fully active or can carry out light work.
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I had targeted breast radiation before chemotherapy and it's been 4 weeks since.
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I need radiation after mastectomy due to a large tumor or many affected lymph nodes.
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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 heart rhythm is normal or I have controlled atrial fibrillation.
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I need full-dose anticoagulation but meet specific criteria.
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I have not had a vascular access device placed in the last 24 hours.
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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 do not have any conditions that cause frequent bleeding.
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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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Invasive Disease-free Survival (IDFS) Rate at 5 Years
Secondary outcome measures
5-year Overall Survival (OS)
The Association Between IDFS and Genotype

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
~5280
Cyclophosphamide
1995
Completed Phase 3
~3780
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17850
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,609 Previous Clinical Trials
40,910,652 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 Patients Enrolled for Breast Cancer
Cancer and Leukemia Group BNETWORK
80 Previous Clinical Trials
112,994 Total Patients Enrolled
20 Trials studying Breast Cancer
30,776 Patients Enrolled for Breast Cancer
Eastern Cooperative Oncology GroupNETWORK
268 Previous Clinical Trials
145,836 Total Patients Enrolled
31 Trials studying Breast Cancer
45,322 Patients Enrolled for Breast Cancer

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00433511 — Phase 3
Breast Cancer Research Study Groups: Arm I (chemotherapy, placebo), Arm II (chemotherapy, bevacizumab), Arm III (chemotherapy, bevacizumab monotherapy)
Breast Cancer Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT00433511 — Phase 3
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00433511 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other clinical trials has Bevacizumab been used in?

"First appearing in 1997 at Spectrum Health Hospital - Butterworth Campus, bevacizumab has undergone 3779 clinical trials. As of now, there are 2063 live studies being conducted; a large portion of these taking place in Saint Helena, California."

Answered by AI

Are patients currently being enrolled in this study?

"Unfortunately, this particular trial is not currently enrolling patients. Although, it's worth noting that there are 804 other clinical trials for adenocarcinoma and 2063 studies involving Bevacizumab that are presently looking for participants."

Answered by AI

Did the FDA sign off on Bevacizumab?

"Bevacizumab has received a score of 3 for safety. This is because it is a Phase 3 trial, meaning that there is data to support the efficacy of the medication as well as multiple rounds of data supporting its safety."

Answered by AI

Has this type of experiment been done before?

"Alfacell launched the first study on bevacizumab in 1997, which then led to the drug's Phase 3 approval. As of now, 2063 studies are ongoing across 3710 cities and 84 countries."

Answered by AI

How many people are participating in this clinical trial?

"This treatment option is no longer available to new patients, as the clinical trial has closed. Bevacizumab and adenocarcinoma trials are still open, with 2063 and 804 studies actively recruiting participants respectively."

Answered by AI

Is this clinical trial widely available in America?

"Patients are currently being enrolled at this trial's 4 centres: Saint Helena Hospital in California, West Michigan Cancer Center in Michigan, Presbyterian Kaseman Hospital in New mexico, and 100 other hospitals."

Answered by AI

What disease does Bevacizumab target?

"Bevacizumab is a medication that is most commonly used to treat Kaposi's sarcoma in AIDS patients. However, it can also be useful in treating other conditions such as recurrent cervical cancer, leukemia, and locally advanced non-small cell lung cancer."

Answered by AI

Who else is applying?

What site did they apply to?
Eastern Maine Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
~288 spots leftby Mar 2025