Breast Cancer Clinical Trial
Neoadjuvant TAC Plus or Minus Bevacizumab(AVF3299)
Summary
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.
Full Description
The study combines bevacizumab with a very efficacious combination chemotherapy regimen for the treatment of stage II or stage III primary breast cancer. Safety of the TAC-bevacizumab combination will be evaluated. In addition, the study design incorporates an initial cycle of bevacizumab or placebo alone. Assessing the isolated effects of bevacizumab in a setting where pre- and post-treatment tissue specimens can be obtained will provide essential information about the mechanisms by which VEGF inhibition affects tumor growth, and represents an ideal opportunity to evaluate the molecular effects of bevacizumab on breast tumor tissue.
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 9 Locations for this study
Los Angeles California, 90095, United States
Pomona California, 91767, United States
Orlando Florida, 32804, United States
Marietta Georgia, 30060, United States
San Antonio Texas, 78207, United States
Edmonton Alberta, T6G 1, Canada
Montreal Quebec, H2W 1, Canada
Dublin , 4, Ireland
Dublin , 8, Ireland
How clear is this clinincal trial information?

Please confirm you are a US based health care provider:
Yes, I am a health care Provider No, I am not a health care providerSign Up Now.
Take Control of Your Disease Journey.
Sign up now for expert patient guides, personalized treatment options, and cutting-edge insights that can help you push for the best care plan.