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Breast CancerPhase 2NCT00203372

Neoadjuvant TAC Plus or Minus Bevacizumab(AVF3299)

A Phase 2 study testing Bevacizumab 7.5 and TAC and Bevacizumab 15 and TAC in people with Breast Cancer, run by Translational Oncology Research International at 9 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Bevacizumab 7.5 and TAC and Bevacizumab 15 and TAC
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
6 participants
Where
9 sitesin 3 countries
Study dates
May 2005to Jun 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

9 sites in 3 countries.

9 sites in 3 countries

United States5 sites

  • UCLA Medical Center

    Los Angeles, California, 90095

  • Northwest Georgia Oncology Centers, P.C.

    Marietta, Georgia, 30060

  • Cancer Institute of Florida, P.A.

    Orlando, Florida, 32804

  • Wilshire Oncology Medical Group, Inc.

    Pomona, California, 91767

  • South Texas Oncology and Hematology, P.A.

    San Antonio, Texas, 78207

Other trials in United States

Canada2 sites

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • McGill University

    Montreal, Quebec, H2W 1S6

Other trials in Canada

Ireland2 sites

  • St. Vincent's University Hospital

    Dublin, 4

  • St. James's Hospital

    Dublin, 8

Other trials in Ireland

About this study

Official title: 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 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.

Read the detailed 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.

Conditions
Breast Cancer
Being tested
Bevacizumab 7.5 and TAC, Placebo 7.5 and Docetaxel, Doxorubicin, and Cyclophosphamide (TAC), Bevacizumab 15 and TAC, Placebo 15 and TAC
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bevacizumab 7.5 and TACDrug

    Bevacizumab given intravenously at a dose of 7.5mg/kg every 3 weeks, followed by docetaxel, doxorubicin and cyclophosphamide (TAC).

  • Placebo 7.5 and Docetaxel, Doxorubicin, and Cyclophosphamide (TAC)Drug

    placebo 7.5 will be adminitered intravenously every 3 weeks followed by TAC

  • Bevacizumab 15 and TACDrug

    one dose of Bevacizumab (15 mg/kg) will be administered intravenously every 3 weeks followed by TAC.

  • Placebo 15 and TACDrug

    one dose of placebo 15 will be administered intravenously every 3 weeks followed by TAC.

Study groups in NCT00203372
Study groupRoleWhat they receive
Bevacizumab 7.5 and TACExperimentalone dose of Bevacizumab (7.5mg/kg) will be administered intravenously every 3 weeks followed by TAC.
Receives: Drug: Bevacizumab 7.5 and TAC
Placebo 7.5 and TACPlacebo comparatorPlacebo7.5 will be administered intravenously every 3 weeks followed by TAC.
Receives: Drug: Placebo 7.5 and Docetaxel, Doxorubicin, and Cyclophosphamide (TAC)
Bevacizumab 15 and TACExperimentalone dose of Bevacizumab (15mg/kg) will be administered intravenously every 3 weeks followed by TAC.
Receives: Drug: Bevacizumab 15 and TAC
Placebo 15 and TACPlacebo comparatorPlacebo 15mg/kg will be administered intravenously every 3 weeks followed by TAC.
Receives: Drug: Placebo 15 and TAC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. •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

    Patients will be evaluated for adverse events (all grades) at each study visit for the duration of their participation in the study. All AEs should be graded using the NCI--CTCAE, Version 3.0. Patients discontinued from the treatment phase of the study for any reason will be evaluated within 30 days after the decision to discontinue treatment.

    Measured: 4 years

  2. •To estimate change from baseline expression of HIF1α as a measure of tumor angiogenesis, after a single dose of bevacizumab as compared to placebo

    Measured: 4 years

Secondary outcomes (4)

  1. •To estimate the rate of CHF in patients receiving TAC with or without bevacizumab

    Measured: 4 years

  2. •To estimate the rates of left ventricular ejection fraction (LVEF) changes as measured by either a decrease of > 15% from baseline, or > 10% to a value below the lower limit of normal (for the institution), in patients receiving TAC or TAC + bevacizumab

    Measured: 4 years

  3. •To investigate the clinical efficacy of TAC and TAC plus bevacizumab by estimating the clinical objective response rate (CR + PR), pathologic complete response rate (pCR), and rate of breast-conserving surgery (BCS)

    Measured: 4 years

  4. •To estimate the rate of post-surgical wound healing complications in patients who receive surgery after TAC or TAC plus bevacizumab

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionJun 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
6 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00203372
Sponsor's protocol ID
TORI B-02
Other IDs
10-001419
Status last verified
Feb 2011
First submitted
12 Sep 2005
Last updated
12 Oct 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab 7.5 and TAC and Bevacizumab 15 and TAC in people with Breast Cancer, run by Translational Oncology Research International at 9 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Canada, Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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 (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00203372.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.

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