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Chemotherapy +/− Bevacizumab for Breast Cancer
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- 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.
- Group 1: Arm I (chemotherapy, placebo)
- Group 2: Arm II (chemotherapy, bevacizumab)
- Group 3: Arm III (chemotherapy, bevacizumab monotherapy)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
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."
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."
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."
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."
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."
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."
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."
Who else is applying?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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