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A Multicenter, Placebo-Controlled, Double-Blind Randomized Phase II Trial of Neoadjuvant Treatment With Single-Agent Bevacizumab or Placebo, Followed by Six Cycles of Docetaxel, Doxorubicin, and Cyclophosphamide (TAC), With or Without Bevacizumab in Patients With Stage II or Stage III Breast Cancer


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Multicenter, Placebo-Controlled, Double-Blind Randomized Phase II Trial of Neoadjuvant Treatment With Single-Agent Bevacizumab or Placebo, Followed by Six Cycles of Docetaxel, Doxorubicin, and Cyclophosphamide (TAC), With or Without Bevacizumab in Patients With Stage II or Stage III Breast Cancer


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

•To evaluate the safety and toxicity of the TAC regimen with the addition of bevacizumab given as preoperative therapy to patients with Stage II or Stage III breast cancer

Safety Issue:

Yes

Principal Investigator

Fairooz Kabbinavar, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Chief Medical Officer

Authority:

United States: Food and Drug Administration

Study ID:

TORI B-02

NCT ID:

NCT00203372

Start Date:

April 2005

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Wilshire Oncology Medical Group, Inc.Rancho Cucamonga, California  91730
UCLA Medical CenterLos Angeles, California  90095-7059
Northwest Georgia Oncology Centers, P.C.Marietta, Georgia  30060
Cancer Institute of Florida, P.A.Orlando, Florida  32804
South Texas Oncology and Hematology, P.A.San Antonio, Texas  78207