NCT02436993

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

A Phase II Study of Breast Cancer Treatment Using Weekly Carboplatin + Paclitaxel With Pertuzumab + Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: University of California, Irvine · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

OBJECTIVES The study component is to evaluate the treatment response and toxicity of the protocol. Objectives for treatment study component: 1.1 To estimate 2-year progression-free survival in patients with breast cancer with tumor more than 1 cm and/or with clinically detected lymph node treated with neoadjuvant weekly Carboplatin and Paclitaxel combined with Trastuzumab + Pertuzumab in HER2-positive disease or with Bevacizumab in HER2-negative disease. 1.2 To measure the microscopic complete pathological response (pCR) rates defined as ypT0 or ypTis tumors in patients treated with this regimen in the neoadjuvant setting. 1.3 To assess complete clinical response (cCR) rates after treatment by physical exam and imaging tests (ultrasonography, mammography, or magnetic resonance imaging) clinical objective response rate (by Response Evaluation Criteria In Solid Tumors (RECIST)) 1.4 To determine the toxicity of this regimen. 1.5 To determine treatment adherence and delivered dose intensity of this regimen. 1.6 To assess the correlation between pCR and cCR. 1.7 To determine the rate of breast conservation following neoadjuvant therapy. 1.8 Determine treatment efficacy according to subgroups defined according to stage and receptor status.

Conditions

• Breast Carcinoma

Interventions

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

Timeline

• Start date: 2015-04-01
• Primary completion: 2023-11-01
• Completion: 2036-12-01
• First posted: 2015-05-07
• Last updated: 2025-07-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study