Phase II Breast Ca Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab or Bevacizumab

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT02436993
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Carboplatin — DRUG
    Area Under the Curve (AUC) 2 IV over 60 minutes weekly for 12 doses
  • Paclitaxel — DRUG
    80 mg/m\^2 IV over 1-3 hours weekly for 12 doses
  • Bevacizumab — DRUG
    10mg/kg IV over 90 or 60 or 30 minutes every other week for 5 doses
  • Trastuzumab — DRUG
    4mg/kg induction, followed by weekly 2mg/kg IV-induction over 90 minutes, then weekly over 30-60 minutes for 12 doses
  • Pertuzumab — DRUG
    840mg induction, followed by 420mg every 3 weeks IV-induction over 60 minutes, then every 3 weeks over 30-60 minutes for 4 doses

Study Details

The purpose of this phase II is to study the efficacy and toxicity of carboplatin and paclitaxel with pertuzumab and trastuzumab in HER2 positive and carboplatin and paclitaxel with bevacizumab in HER2 negative in the neoadjuvant setting for the treatment of breast cancer.

Key Dates

First listed
May 7, 2015
Start date
Apr 30, 2015
Status verified
Dec 2024
Primary completion
Nov 30, 2023
Completion
Dec 31, 2036

Study Design

Enrollment
120 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Carboplatin+Paclitaxel+Bevacizumab (HER2-)
    Carboplatin weekly 12 doses Paclitaxel weekly 12 doses Bevacizumab every other week, 5 doses
  • Experimental: Carboplatin+Paclitaxel+Trastuzumab+Pertuzumab (HER2+)
    Carboplatin weekly 12 doses Paclitaxel weekly 12 doses Trastuzumab weekly 12 doses Pertuzumab every 3 weeks, 4 doses

Primary Outcome Measure

2-year progression free survival in patients treated with weekly carboplatin and paclitaxel combined with either trastuzumab and pertuzumab for HER2-positive patients or bevacizumab for HER2-negative patients in the neoadjuvant setting [ Time Frame: 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
UC Irvine Health/Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-

Find similar trials in Orange, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
UC Irvine Health/Chao Family Comprehensive Cancer Center· Orange, CA

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