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

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
SCRI Development Innovations, LLC
Study ID
NCT00392392
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nab-paclitaxel — DRUG
    ABI-007
  • Bevacizumab — DRUG
    Bevacizumab
  • Trastuzumab — DRUG
    Trastuzumab

Study Details

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.

Key Dates

First listed
Oct 26, 2006
Start date
Oct 31, 2006
Status verified
Sep 2013
Primary completion
Apr 30, 2008
Completion
Dec 31, 2011

Study Design

Enrollment
29 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • 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.

Primary 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 [ Time Frame: 18 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
Florida Cancer SpecialistsFort MyersFlorida33901-
Florida Hospital Cancer InstituteOrlandoFlorida32804-
Northeast Georgia Medical CenterGainesvilleGeorgia30501-
Grand Rapids Clinical Oncology ProgramGrand RapidsMichigan49503-
Chattanooga Oncology Hematology AssociatesChattanoogaTennessee37404-
Tennessee Oncology, PLLCNashvilleTennessee37023-

Find similar trials in Fort Myers, FL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Florida Cancer Specialists· Fort Myers, FLFlorida Hospital Cancer Institute· Orlando, FLNortheast Georgia Medical Center· Gainesville, GAGrand Rapids Clinical Oncology Program· Grand Rapids, MIChattanooga Oncology Hematology Associates· Chattanooga, TNTennessee Oncology, PLLC· Nashville, TN

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