Neoadjuvant TAC Plus or Minus Bevacizumab(AVF3299)

Completed · Phase 2 · Has a placebo group

Conditions studied: Breast Cancer

In brief

The purpose of this study is to evaluate the safety of the TAC-bevacizumab combination and investigate whether changes in gene expression, or the expression of specific biomarkers, are either predictive of response to bevacizumab or indicative of response.

Key facts

Study ID

NCT00203372

Run by

Translational Oncology Research International

People needed

6

Starts

2005-05-01

Last updated by the study team

2015-10-12

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically proven adenocarcinoma of the breast
• Stage II (T > 3 cm) or Stage III disease (except inflammatory breast cancer), according to the AJCC Staging Manual, 6th Edition, 2002
• HER2-negative disease (as defined by fluorescence in situ hybridization [FISH])
• ECOG performance status 0-1
• No prior chemotherapy, radiotherapy, or endocrine therapy for invasive or noninvasive breast cancer
• Normal cardiac function (ejection fraction > lower limit of normal) as determined by MUGA or echocardiogram
• Adequate organ function

You may not qualify if…

• Prior chemotherapy or radiotherapy for Stage II or Stage III breast cancer
• Inflammatory Breast Cancer, clinically defined as the presence of erythema or induration involving one-third or more of the breast
• Prior treatment with an anti-angiogenic agent
• Prior ipsilateral radiation therapy for invasive or non-invasive breast cancer
• Bilateral invasive breast cancer
• Concurrent therapy with any other non-protocol anti-cancer therapy
• Current therapy with hormone replacement therapy, or any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulators (agents must be stopped prior to randomization)
• Presence of neuropathy > grade 2 (NCI-CTC version 3.0) at baseline
• Presence of any non-healing wound, bone fracture, or ulcer, or the presence of clinically significant (> grade 2) peripheral vascular disease
• History of any other malignancy within the past 5 years, with the exception of non-melanoma skin cancer or carcinoma-in-situ of the cervix
• Clinically significant cardiovascular disease (e.g., hypertension [BP > 150/100], myocardial infarction or stroke within 6 months, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication
• Active peptic ulcer disease, inflammatory bowel disease, or other gastrointestinal condition increasing the risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to beginning therapy
• Active, uncontrolled infection requiring parenteral antimicrobials
• The presence of any other medical or psychiatric disorder that, in the opinion of the treating physician, would contraindicate the use of the drugs in this protocol or place the subject at undue risk for treatment complications
• Pregnancy or lactation
• A history of a severe hypersensitivity reaction to bevacizumab, or docetaxel or other drugs formulated with polysorbate 80
• Evidence of bleeding diathesis or coagulopathy
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to beginning therapy, or anticipation of the need for a major surgical procedure during the course of the study; minor surgical procedure, fine needle aspiration, or core biopsy within 7 days prior to beginning therapy
• Urine protein:creatinine ratio of > 1.0 at screening

Where it is running

• UCLA Medical Center — Los Angeles, California, United States
• Wilshire Oncology Medical Group, Inc. — Pomona, California, United States
• Cancer Institute of Florida, P.A. — Orlando, Florida, United States
• Northwest Georgia Oncology Centers, P.C. — Marietta, Georgia, United States
• South Texas Oncology and Hematology, P.A. — San Antonio, Texas, United States
• Cross Cancer Institute — Edmonton, Alberta, Canada
• McGill University — Montreal, Quebec, Canada
• St. Vincent's University Hospital — Dublin, Ireland
• St. James's Hospital — Dublin, Ireland

Full record on ClinicalTrials.gov

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