Phase II Breast Ca Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab or Bevacizumab
NCT02436993 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2025-07-14
Summary
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.
Conditions
- Breast Carcinoma
Interventions
- DRUG
-
Area Under the Curve (AUC) 2 IV over 60 minutes weekly for 12 doses
- DRUG
-
80 mg/m\^2 IV over 1-3 hours weekly for 12 doses
- DRUG
-
10mg/kg IV over 90 or 60 or 30 minutes every other week for 5 doses
- DRUG
-
4mg/kg induction, followed by weekly 2mg/kg IV-induction over 90 minutes, then weekly over 30-60 minutes for 12 doses
- 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
Sponsors & Collaborators
-
University of California, Irvine
lead OTHER
Principal Investigators
-
Rita Mehta, MD · University of California, Irvine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-04-30
- Primary Completion
- 2023-11-30
- Completion
- 2036-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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