Weekly Paclitaxel/Carboplatin/Bevacizumab as First Line Therapy for Triple Negative Breast Cancer

Sponsor
Hellenic Oncology Research Group
Study ID
NCT00691379
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Carboplatin — DRUG
    Carboplatin (IV) 2 AUC on day 1,8,15. Treatment repeats every 4 weeks until progression
  • Bevacizumab — DRUG
    Bevacizumab (IV) 10 mg/kg on day 1,15. Treatment repeats every 4 weeks until progression
  • Paclitaxel — DRUG
    Paclitaxel (IV) 90 mg/m2,on day 1,8,15. Treatment repeats every 4 weeks until progression

Study Details

This study will evaluate the efficacy of weekly paclitaxel-carboplatin combination plus bevacizumab as first line treatment in patients with metastatic triple negative breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (CTCs) in this population

Key Dates

First listed
Jun 5, 2008
Start date
Apr 30, 2008
Status verified
Sep 2016
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016

Study Design

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

Arms

  • Experimental: 1
    Paclitaxel/Carboplatin/Bevacizumab

Primary Outcome Measure

Overall Response Rate [ Time Frame: Objective responses confirmed by CT or MRI (on 3rd and 6th cycle) ]

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