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

This study has been completed.
Sponsor:
Collaborators:
Celgene Corporation
Genentech
Information provided by (Responsible Party):
SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier:
NCT00392392
First received: October 25, 2006
Last updated: September 17, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: nab-paclitaxel
Drug: Bevacizumab
Drug: Trastuzumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Preoperative Bevacizumab and Trastuzumab Administered With ABI-007 and Carboplatin in HER2 Overexpressing Breast Cancer

Resource links provided by NLM:


Further study details as provided by SCRI Development Innovations, LLC:

Primary Outcome Measures:
  • Pathologic Complete Response Rate (PCRR), the Percentage of Patients Who Have No Evidence of Cancer in the Breast or Lymph Nodes Following Surgery [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Pathologic complete response was defined as the absence of residual invasive cancer in the breast (pT0) and axillary lymph nodes (pN0).


Enrollment: 29
Study Start Date: October 2006
Study Completion Date: December 2011
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: nab-paclitaxel
ABI-007
Other Names:
  • Abraxane
  • ABI-007
Drug: Bevacizumab
Bevacizumab
Other Name: Avastin
Drug: Trastuzumab
Trastuzumab
Other Name: Herceptin

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00392392

Locations
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
United States, Georgia
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Michigan
Grand Rapids Clinical Oncology Program
Grand Rapids, Michigan, United States, 49503
United States, Tennessee
Chattanooga Oncology Hematology Associates
Chattanooga, Tennessee, United States, 37404
Tennessee Oncology, PLLC
Nashville, Tennessee, United States, 37023
Sponsors and Collaborators
SCRI Development Innovations, LLC
Celgene Corporation
Genentech
Investigators
Principal Investigator: Denise Yardley, MD SCRI Development Innovations, LLC
  More Information

Publications:
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00392392     History of Changes
Other Study ID Numbers: SCRI BRE 83
Study First Received: October 25, 2006
Results First Received: January 11, 2013
Last Updated: September 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by SCRI Development Innovations, LLC:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Bevacizumab
Trastuzumab
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on September 30, 2014