Primary Systemic Therapy Using Sequential Docetaxel/Cyclophosphamide/Bevacizumab Followed by Doxorubicin in Operable/Locally Advanced Breast Cancer
Prior to being enrolled in this study, they will undergo an evaluation to determine
eligibility. The study doctor will obtain a complete medical history, complete a physical
examination including blood pressure and heart rate. The doctor will also obtain a baseline
ECG as well as blood tests (approximately two tablespoons of blood). In order to decrease
the effects of food, exercise and the sleep/wake cycle variability, all blood samples must
be taken between 8AM - 10AM and patients will need to fast (no food or drink) for 10 hours
prior to the blood test. Patients will also need to strain from working out prior to the
blood test. The study will ask for a list of current medications. Patients will not be
eligible if they have a history of or now require long-term anticoagulant (blood thinner)
therapy (i.e. Coumadin or anything patients may be taking to prevent blood clots) have an
allergy to bevacizumab or any other drugs used in the study.
Many of the following evaluations are commonly done to determine diagnosis and/or stage of
breast cancer and may have already had some of all of them done. If the following procedures
were not done within three weeks, they will need to be done again prior to receiving any
- Diagnosis of breast cancer by fine needle aspiration or core needle biopsy will be
required for entry in this study.
- Clip Placement - a clip will be placed in the tumor during the core biopsies as a
marker to assist surgeons at the time of surgery.
- Tumor Clip Placements - a caliper is similar to a ruler and is used to measure the
tumor from the outside of the body instead of always having to use an ultrasound or
- Tumor Ultrasound - this is a non-invasive exam that uses sound waves to produce a
picture of your tumor.
All study participants will be treated with bevacizumab 15 mg/kg plus docetaxel 75 mg/m2 and
cyclophosphamide 500 mg/m2 every three weeks for a total of four treatments. Three weeks
after the completion of this part of the treatment patients will start receiving doxorubicin
60 mg/m2 every three weeks for a total of four treatments. All these drugs will be given as
intravenous infusion on the first day of each three-week period.
Patients will come in for every three week visits and have a physical exam including blood
pressure and heart rate. Medications lists will be taken and any side effects that may have
been experienced. Tumor caliper measurements will be done and blood will be drawn at each of
A mammogram and MUGA scan will be done again just prior to surgery. Patients will undergo
tumor surgery approximately six months after treatment. Patients will need to visit the
study physician one month after surgery for another physical examination including blood
pressure and heart rate, an assessment of any side effects and a list of current
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate the efficacy in terms of pathologic response of the combination of bevacizumab with docetaxel/cyclophosphamide followed by doxorubicin in women with operable/locally advanced breast cancer in the neo-adjuvant setting.
Issam Makhoul, MD
University of Arkansas
United States: Institutional Review Board
|University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|