CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 74 enrolled
Drug / intervention
trastuzumab +3 morebiological
Likely dose
Carboplatin AUC 6 IV on day 1-2 of cycles 1-8; Docetaxel 75 mg/m² IV on day 1-2 of cycles 1-8; Trastuzumab 4 mg/kg IV loading dose then 2 mg/kg IV on days 8 and 15 of cycles 1-4 (pre-op) and cycles 5-7 (post-op), with 2 mg/kg IV on days 1, 8, 15 and 6 mg/kg IV on day 22 of cycle 8AI-extracted
Key inclusion· 7
  • ✓Confirmed infiltrating adenocarcinoma of the breast
  • ✓Primary breast cancer >5 cm in size OR skin/chest wall involvement, any nodal status, without metastasis
  • ✓No prior radiation to the involved breast
  • ✓ECOG performance status 0-2
Key exclusion· 8
  • ✕Evidence of metastatic disease
  • ✕Prior chemotherapy with trastuzumab, docetaxel, or carboplatin
  • ✕Any breast cancer drug therapy within the past 5 years
  • ✕History of allergy to polysorbate or castor oil

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

Search/NCT00068341
NCT00068341Phase 2Completed
CompareCT.gov

Neoadjuvant Treatment and Molecular Characterization of Locally Advanced Breast Cancer

Jonsson Comprehensive Cancer Center·interventional·Posted Sep 11, 2003·Updated Sep 9, 2020

In Brief

A Phase 2 clinical trial evaluating trastuzumab, carboplatin, and 1 other intervention for Breast Cancer. Completed, enrolled 74 participants across 4 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer. PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone before surgery in treating women with locally advanced breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsAventis Pharmaceuticals, Genentech, Inc.

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 11, 2003
Enrollment StartJul 1, 2003
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 10.3 yearsPosted 22.8 years ago

Interventions

trastuzumabbiological

Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV

carboplatindrug

Cycle 1-8 Day 1 or 2 AUC = 6 IV

docetaxeldrug

Cycle 1-8 Day 1 or 2: 75 mg/m2 IV

trastuzumabbiological

Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV