Phase II Study With Abraxane, Bevacizumab and Carboplatin in Triple Negative Metastatic Breast Cancer

Part of paid clinical trials in Charlotte, North Carolina.

Sponsor
Duke University
Study ID
NCT00479674
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Abraxane — DRUG
    100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..
  • Bevacizumab — DRUG
    10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.
  • Carboplatin — DRUG
    area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death.

Study Details

Taxanes (such as paclitaxel) are highly active to treat breast cancer. Abraxane® (nanoparticle albumin-bound paclitaxel) compared to standard paclitaxel improves efficacy and tolerability. When combined with a taxane, platinum agents improve response in metastatic breast cancer, with carboplatin conferring less toxicity than cisplatin. Monoclonal antibodies including bevacizumab target vascular endothelial growth factor (VEGF) to reduce angiogenesis. We hypothesize that the previously-untested combination of weekly Abraxane® and carboplatin plus biweekly bevacizumab will lengthen time to progression without producing intolerable toxicity.

Key Dates

First listed
May 28, 2007
Start date
May 31, 2007
Status verified
Jan 2015
Primary completion
Mar 31, 2014
Completion
Mar 31, 2014

Study Design

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

Arms

  • Experimental: Abraxane, Carboplatin, Bevacizumab
    Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15

Primary Outcome Measure

Best Clinical Response Expressed as Percentage of Participants Treated With Combination Regimen of Weekly Abraxane® and Carboplatin Plus Biweekly Bevacizumab to Treat Women With Stage IV or Inoperable Stage III "Triple Negative" Metastatic Breast Cancer. [ Time Frame: 5 years ]

Locations (4)

FacilityCityStateZIPSite coordinators
Presbyterian Health CareCharlotteNorth Carolina28204-
Northeast Oncology AssociatesConcordNorth Carolina28205-
Duke University Medical CenterDurhamNorth Carolina27710-
Forsyth Regional Cancer CenterWinston-SalemNorth Carolina27103-3019-

Find similar trials in Charlotte, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Presbyterian Health Care· Charlotte, NCNortheast Oncology Associates· Concord, NCDuke University Medical Center· Durham, NCForsyth Regional Cancer Center· Winston-Salem, NC

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