Primary Systemic Therapy in Operable/Locally Advanced Breast Cancer

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The main purpose of this study is to find out what effects taking the drug bevacizumab together with two chemotherapeutic agents, docetaxel and cyclophosphamide followed by doxorubicin alone before surgery will on breast cancer. Bevacizumab will be given for twelve weeks in combination with chemotherapy then it ill be held during the administration of doxorubicin. Twenty-eight to fifty-six days after undergoing surgery, all patients will receive nine three-weekly infusions of bevacizumab.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Arkansas
• Collaborator: Genentech, Inc.
• Treatments: Bevacizumab; Cyclophosphamide; Docetaxel

Criteria

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