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

NCT00392392 | Completed Phase 2 Results

• 1 other identifier: SCRI BRE 83
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 6

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.

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Intervention

EXPERIMENTAL

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.

Drug: nab-paclitaxel; Drug: Bevacizumab; Drug: Trastuzumab

Interventions

nab-paclitaxel DRUG

ABI-007

Also known as: Abraxane, ABI-007

Intervention

Bevacizumab DRUG

Bevacizumab

Also known as: Avastin

Intervention

Trastuzumab DRUG

Trastuzumab

Also known as: Herceptin

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Celgene Corporation: collaborator
• Genentech, Inc.: collaborator

Study Sites (6)

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Florida Hospital Cancer Institute

Orlando, Florida, 32804, United States

Location

Northeast Georgia Medical Center

Gainesville, Georgia, 30501, United States

Location

Grand Rapids Clinical Oncology Program

Grand Rapids, Michigan, 49503, United States

Location

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, 37404, United States

Location

Tennessee Oncology, PLLC

Nashville, Tennessee, 37023, United States

Location

Related 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.

  PMID: 21729666 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

130-nm albumin-bound paclitaxel; Albumin-Bound Paclitaxel; Bevacizumab; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: John Hainsworth, MD
• Organization: Sarah Cannon Research Institute

ASKSARAH@scresearch.net

1-877-691-7274

Study Officials

• Denise Yardley, MD

  SCRI Development Innovations, LLC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2006
• First Posted: October 26, 2006
• Study Start: October 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: December 1, 2011
• Last Updated: September 20, 2013
• Results First Posted: February 13, 2013

Record last verified: 2013-09

Locations

US (6)