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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
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 belowSelect...
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
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
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
~2320
Doxorubicin Hydrochloride
2019
Completed Phase 3
~17860
Paclitaxel
2011
Completed Phase 4
~5810
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,868 Previous Clinical Trials
41,005,843 Total Patients Enrolled
946 Trials studying Breast Cancer
1,544,013 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
146,601 Total Patients Enrolled
31 Trials studying Breast Cancer
46,087 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer is not HER2 positive as determined by specific tests.I have cancer in both breasts, but the more advanced one qualifies for the trial.I have had a heart attack in the last 12 months.My breast cancer is at high risk of spreading.My breast cancer has spread to at least one of my underarm lymph nodes.My breast cancer is ER- and larger than 1 cm, or it's ER+ and meets specific size and score criteria.I had targeted breast radiation before chemotherapy and it's been 4 weeks since.I need radiation after mastectomy due to a large tumor or many affected lymph nodes.I haven't had chemotherapy or hormone therapy for my breast cancer, nor used certain cancer drugs before.My breast surgery removed all visible cancer; LCIS at the margins is okay.I am fully active or can carry out light work.It's been 1 to 3 months since my last breast cancer surgery.I have completed surgery for breast cancer, including removal of the breast or part of it and checking the lymph nodes.I do not have serious heart or brain blood vessel problems.I do not have any bleeding disorders.I do not have any non-healing wounds, fractures, or recent serious abdominal issues.I am not allergic to paclitaxel or certain drug ingredients.I will receive focused breast radiation after chemotherapy.I have had a stroke, TIA, or bleeding in my brain.I have heart failure that affects my daily activities.I have had a blockage in the arteries supplying my intestines.I have unstable chest pain.I haven't had any major surgery in the last 28 days, except for a biopsy or device placement.I had breast-saving surgery and will receive radiation as specified by my doctor.My heart rhythm is normal or I have controlled atrial fibrillation.I need full-dose anticoagulation but meet specific criteria.I have not had a vascular access device placed in the last 24 hours.My blood clotting time is normal on my current blood thinner medication.I have moderate to severe blockage in my arteries.I do not have any conditions that cause frequent bleeding.I will receive radiation to the entire breast after chemotherapy.I do not have signs of inflammation or immovable lumps under my arm.
Research Study Groups:
This trial has the following groups:- Group 1: Arm I (chemotherapy, placebo)
- Group 2: Arm II (chemotherapy, bevacizumab)
- Group 3: Arm III (chemotherapy, bevacizumab monotherapy)
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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