Know Cancer

forgot password

Primary Systemic Therapy Using Sequential Docetaxel/Cyclophosphamide/Bevacizumab Followed by Doxorubicin in Operable/Locally Advanced Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Breast Cancer

Thank you

Trial Information

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
study therapy.

- 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
these visits.

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

Inclusion Criteria:

- The diagnosis of breast cancer established by biopsy.

- Normal kidney function

- Normal LVEF evaluated by MUGA Scan

- >18 years of age

- Good performance status defined by ECOG scale of 0 or 1

- Consent

- Women of childbearing potential must have a negative pregnancy test.

- Use of effective means of contraception in subjects of child-bearing potential while
on treatment and for at least 3 months thereafter.

- Peripheral Neuropathy: must be < grade 1

- Hematologic (minimal values)

- Absolute neutrophil count >1,500/mm3

- Hemoglobin >8.0 g/dl

- Platelet count >100,000/mm3

- Hepatic

- Total bilirubin
- AST, ALT, Alkaline Phosphatase must be within range

Exclusion Criteria:

- Patients with locally advanced breast cancer with skin ulcerations

- Stage IV breast cancer

- Inflammatory breast cancer

- Allergy to any component of the treatment regimen

- Women who are breast feeding

- Pregnancy or refusal to use effective contraception

- Inability to comply with study and/or follow-up procedures.

- Current, recent, or planned participation in a experimental drug study

- Blood pressure of >150/100 mmHg. Essential hypertension well controlled with anti
hypertensives is not an exclusion criterion.

- unstable angina

- New York Heart Association Grade II or greater congestive heart failure

- history of myocardial infarction within 6 months

- history of stroke within 6 months

- Clinical significant peripheral vascular disease

- Evidence of bleeding diathesis or coagulopathy

- Presence of central nervous system or brain metastasis

- major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to day 0

- Minor surgical procedure such as fine needle aspirations or core biopsy within 7 days
prior to day 0

- Pregnant or lactating

- Urine protein: creatinine ratio >1.0 at screening

- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
abscess within 6 months prior to Day 0

- Serious, non-healing wound, ulcer, or bone fracture

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

upon surgery

Safety Issue:


Principal Investigator

Issam Makhoul, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Arkansas


United States: Institutional Review Board

Study ID:

UARK 2004-59



Start Date:

September 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • Operable and Locally advanced Breast Cancer
  • Breast Neoplasms



University of Arkansas for Medical Sciences Little Rock, Arkansas  72205