Preoperative Bevacizumab and Trastuzumab With ABI-007 and Carboplatin in HER2+ Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00392392
• Other study ID #: SCRI BRE 83
• Status: Completed
• Phase: Phase 2
• First received: October 25, 2006
• Last updated: September 17, 2013
• Start date: October 2006
• Est. completion date: December 2011

Study information

• Verified date: September 2013
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This trial combines trastuzumab and bevacizumab monoclonal antibodies, with ABI-007 and carboplatin, as neoadjuvant therapy in previously untreated locally advanced breast cancers demonstrating HER2 gene amplification. It is hoped that this novel combination will result in increased pathologic response rates that will translate into long term outcome improvements in HER2 positive patients with locally advanced breast cancer.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: December 2011
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• nab-paclitaxel
ABI-007
• Bevacizumab
Bevacizumab
• Trastuzumab
Trastuzumab

Locations

Country	Name	City	State
United States	Chattanooga Oncology Hematology Associates	Chattanooga	Tennessee
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Northeast Georgia Medical Center	Gainesville	Georgia
United States	Grand Rapids Clinical Oncology Program	Grand Rapids	Michigan
United States	Tennessee Oncology, PLLC	Nashville	Tennessee
United States	Florida Hospital Cancer Institute	Orlando	Florida

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Celgene Corporation, Genentech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

Yardley DA, Raefsky E, Castillo R, Lahiry A, Locicero R, Thompson D, Shastry M, Burris HA 3rd, Hainsworth JD. Phase II study of neoadjuvant weekly nab-paclitaxel and carboplatin, with bevacizumab and trastuzumab, as treatment for women with locally advanced HER2+ breast cancer. Clin Breast Cancer. 2011 Oct;11(5):297-305. doi: 10.1016/j.clbc.2011.04.002. Epub 2011 May 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in the Breast or Lymph Nodes Following Surgery	Pathologic complete response was defined as the absence of residual invasive cancer in the breast (pT0) and axillary lymph nodes (pN0).	18 months	No