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

NCT ID: NCT00392392

Last Updated: 2013-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2011-12-31

Brief 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.

Detailed 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

Conditions

Breast Cancer

Keywords

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.

Group Type: EXPERIMENTAL

nab-paclitaxel

Intervention Type: DRUG

ABI-007

Bevacizumab

Intervention Type: DRUG

Bevacizumab

Trastuzumab

Intervention Type: DRUG

Trastuzumab

Interventions

nab-paclitaxel

ABI-007

Intervention Type: DRUG

Bevacizumab

Bevacizumab

Intervention Type: DRUG

Trastuzumab

Trastuzumab

Intervention Type: DRUG

Other Intervention Names

Abraxane; ABI-007; Avastin; Herceptin

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denise Yardley, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Locations

Florida Cancer Specialists

Fort Myers, Florida, United States

Florida Hospital Cancer Institute

Orlando, Florida, United States

Northeast Georgia Medical Center

Gainesville, Georgia, United States

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, United States

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, United States

Tennessee Oncology, PLLC

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 21729666 (View on PubMed)

Other Identifiers

SCRI BRE 83

Identifier Type: -

Identifier Source: org_study_id