CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 127 enrolled
Drug / intervention
Carboplatin +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00618657
NCT00618657Phase 2Completed

A Phase II Study of Breast Cancer Treatment Using Weekly Carboplatin+Nab-paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting

University of California, Irvine·interventional·Posted Feb 20, 2008·Updated Feb 28, 2024

In Brief

A Phase 2 clinical trial evaluating Carboplatin, paclitaxel albumin-stabilized nanoparticle formulation, and 4 other interventions for Breast Cancer and 9 related conditions. Completed, enrolled 127 participants across 1 site.

Detailed Summary

This phase II is studying the side effects and how well carboplatin and paclitaxel albumin-stabilized nanoparticle formulation when together with bevacizumab or trastuzumab before surgery works in treating patients with stage I-III breast cancer. Drugs used in chemotherapy, such as carboplatin and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab and trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving more than one drug (combination chemotherapy) and monoclonal antibody therapy together before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Study Details

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 20, 2008
Enrollment StartFeb 1, 2008
Primary CompletionJul 1, 2021
TodayJul 2, 2026
Enrollment to primary: 13.4 yearsPosted 18.4 years ago

Interventions

Carboplatindrug

Given IV

paclitaxel albumin-stabilized nanoparticle formulationdrug

Given IV

bevacizumabdrug

Given IV

trastuzumabdrug

Given IV

magnetic resonance imagingprocedure

Optional correlative studies

therapeutic conventional surgeryprocedure

Post-chemotherapy surgery for patients with a response or stable disease must take place no sooner than 21 days after last dose of Herceptin; and 40 days after last dose of bevacizumab to allow for normalization of blood counts