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Alkylating agents
Chemotherapy + Bevacizumab for Early-Stage Breast Cancer
N/A
Waitlist Available
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status 0-1
Histologically or cytologically confirmed invasive breast cancer meeting the specified criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Study Summary
This trial is studying the side effects and efficacy of giving bevacizumab with doxorubicin and cyclophosphamide followed by paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab to patients who have undergone surgery for early-stage breast cancer.
Who is the study for?
This trial is for adults with early-stage breast cancer who've had surgery. They must have normal organ function, blood counts within specific ranges, and a performance status indicating they can care for themselves. Pregnant or nursing individuals are excluded, as well as those with high blood pressure, recent heart issues, uncontrolled seizures or illnesses that could affect study participation.Check my eligibility
What is being tested?
The trial tests the effectiveness of bevacizumab (a monoclonal antibody) combined with chemotherapy drugs doxorubicin and cyclophosphamide followed by paclitaxel after surgery in patients. The goal is to see if this combination helps kill any remaining cancer cells post-surgery.See study design
What are the potential side effects?
Potential side effects include high blood pressure due to bevacizumab's effect on blood vessels; heart problems from doxorubicin; immune system suppression leading to infection risk from cyclophosphamide; and allergic reactions or nerve damage from paclitaxel.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My breast cancer diagnosis was confirmed through tissue examination.
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My breast cancer is not HER2 positive according to tests.
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I am either before or after menopause.
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My kidney function is normal.
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I know my cancer's hormone receptor status.
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I am eligible for chemotherapy with anthracycline and taxane.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety
Secondary outcome measures
Noncardiac toxicity
Overall survival
Time to tumor recurrence
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Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,078 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,285 Patients Enrolled for Breast Cancer
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,933 Previous Clinical Trials
585,545 Total Patients Enrolled
202 Trials studying Breast Cancer
81,062 Patients Enrolled for Breast Cancer
Maura N. Dickler, MDStudy ChairMemorial Sloan Kettering Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have serious blood vessel problems in my arms or legs.I have more than one breast cancer tumor at the same time.You are currently receiving other treatments for cancer.I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.I am fully active or can carry out light work.You had a serious injury in the last 28 days.I am not allergic to the drugs used in this study, except for paclitaxel.Your urine protein level compared to creatinine level is less than or equal to 1.0.I have previously received anthracycline therapy.Your blood clotting tests are normal.Your bilirubin levels are within the normal range.My breast cancer diagnosis was confirmed through tissue examination.I haven't had any abdominal issues like fistula, perforation, or abscess in the last 6 months.My breast cancer is not HER2 positive according to tests.Your liver enzyme levels (AST or ALT) are not more than 2.5 times the normal limit.Your blood pressure is higher than 150 over 100.I am either before or after menopause.I have heart failure that affects my daily activities.Your platelet count is at least 100,000 per cubic millimeter.My seizures are not managed with my current medication.I am either male or female.I am on a full-dose blood thinner treatment.My kidney function is normal.You need to have a test that shows you are not pregnant.I am currently on hormone therapy to prevent cancer.My condition is at stage IV.I have an active stomach or upper small intestine ulcer.I will start treatment within 84 days after my last surgery.You have enough infection-fighting white blood cells in your body.I have had a disease that affects my brain or nerves.I know my cancer's hormone receptor status.I have unstable chest pain.I have had a stroke in the past.I have not had a heart attack or stroke in the last year.I have a serious wound or fracture that is not healing.I am eligible for chemotherapy with anthracycline and taxane.Your heart function is normal based on a MUGA scan before starting the trial.
Research Study Groups:
This trial has the following groups:Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research looking for more participants?
"The trial you're inquiring about was last updated in 2014 and is not currently recruiting patients for participation. However, there are 2,699 other clinical trials that are actively looking for volunteers."
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