CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 48 enrolled
Drug / intervention
trastuzumab, docetaxel and carboplatin in dose dense regimendrug
Likely dose
Trastuzumab 4 mg/kg day 1, then 2 mg/kg weekly x 11; carboplatin 6 mg AUC on days 1, 15, 29, 43; docetaxel 75 mg/m² on days 1, 15, 29, 43AI-extracted
Key inclusion· 3
  • ✓HER-2 overexpressing breast cancer
  • ✓Clinical stage 2-3B
  • ✓Normal ejection fraction
Key exclusion· 2
  • ✕Metastatic disease
  • ✕Low ejection fraction

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

Search/NCT00232479
NCT00232479Phase 2Completed
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Phase II Study of Dose Dense Carboplatin and Taxotere With Herceptin As Primary Systemic Therapy in Breast Cancer

University of Miami·interventional·Posted Oct 4, 2005·Updated Aug 21, 2012

In Brief

A Phase 2 clinical trial evaluating trastuzumab, docetaxel and carboplatin in dose dense regimen for Breast Cancer. Completed, enrolled 48 participants across 1 site.

Detailed Summary

Dose dense therapy has been shown to increase survival in the adjuvant setting of breast cancer. It is unknown if dose dense therapy will improve survival in tumors that express her-2. This study evaluates a neoadjuvant regimen containing carboplatin, taxotere and herceptin when used in a dose dense manner in patients with large breast cancers. The endpoint of pathologic complete response is used as a surrogate marker for survival.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsAventis Pharmaceuticals

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 4, 2005
Enrollment StartSep 1, 2005
Primary CompletionMay 1, 2008
Study CompletionJun 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 20.7 years ago

Interventions

trastuzumab, docetaxel and carboplatin in dose dense regimendrug

trastuzumab 4 mg/kg day 1 and then 2 mg/kg/week x 11, carboplatin 6 mg AUC Day 1, 15, 29, 43, docetaxel 75 mg/meter squared Days 1, 15, 29, 43, neulasta 6 mg Day 2, 16, 30, 44