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Phase II Study of Preoperative Bevacizumab and Trastuzumab Administered With ABI-007 and Carboplatin in HER2 Overexpressing Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase II Study of Preoperative Bevacizumab and Trastuzumab Administered With ABI-007 and Carboplatin in HER2 Overexpressing Breast Cancer

All eligible patients will receive induction chemotherapy prior to consideration of primary
surgical intervention. If surgical intervention is deemed not to be in the best interest of
the patient, patient will go off study at the time of evaluation for surgery. Upon
completion of chemotherapy and surgery, all ER + and/or PR + patients will be placed on
Tamoxifen 20 mg/qd or an aromatase inhibitor.

Induction preoperative therapy:

- Bevacizumab

- Trastuzumab

- ABI-007

- Carboplatin

Postoperative Adjuvant Therapy:

- Bevacizumab

- Trastuzumab

Inclusion Criteria:

- Female patients with histologically confirmed adenocarcinoma of the breast or
inflammatory breast cancer

- Clinical stage T 1-4, N 0-3, M0

- FISH+ HER2 gene amplified breast cancer

- 18 years or older

- Normal cardiac function

- Performance status 0-2

- Cannot have received any prior chemotherapy for this disease or cannot have received
chemotherapy for any other cancer in the past 5 years.

- Previous diagnosis of noninvasive breast cancer is OK.

- Must have adequate bone marrow, renal and liver function.

- Pregnant or lactating females not allowed.

- Preexisting peripheral neuropathy must be equal to or less than grade 1

- Must have archived tumor tissue for tissue testing.

Exclusion Criteria:

You cannot be in this study if you any of the following:

- History of cardiac disease, with New York Heart Association Class II or greater with
congestive heart failure

- Any heart attack, stroke or TIAs within the last 6 months or serious arrhythmias
needing medication; no bleeding diathesis or coagulopathy.

- No prior investigational drug within the last 30 days

- No prior trastuzumab or bevacizumab therapy

There are additional inclusion/exclusion criteria. The study center will determine if you
meet all of the criteria. If you do not qualify for the trial, study personnel will
explain the reasons.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in the Breast or Lymph Nodes Following Surgery

Outcome Description:

Pathologic complete response was defined as the absence of residual invasive cancer in the breast (pT0) and axillary lymph nodes (pN0).

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

Denise Yardley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute


United States: Food and Drug Administration

Study ID:




Start Date:

October 2006

Completion Date:

December 2011

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast Neoplasms



Florida Hospital Cancer Institute Orlando, Florida  32804
Florida Cancer Specialists Fort Myers, Florida  33901
Northeast Georgia Medical Center Gainesville, Georgia  30501
Grand Rapids Clinical Oncology Program Grand Rapids, Michigan  49503
Tennessee Oncology, PLLC Clarksville, Tennessee  37043
Chattanooga Oncology Hematology Associates Chattanooga, Tennessee  37404