CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 81 enrolled
Drug / intervention
Herceptin +3 moredrug
Likely dose
Herceptin: one dose followed by weekly injections weeks 3–14; Navelbine: weekly weeks 3–14; Taxotere: every 3 weeks weeks 3–14; Carboplatin: every 3 weeks weeks 3–14AI-extracted
Key inclusion· 4
  • ✓Stage II or III breast cancer
  • ✓HER-2 positive tumors
  • ✓Age >18 years
  • ✓ECOG performance status ≥1
Key exclusion· 9
  • ✕Prior treatment with Herceptin, taxanes, doxorubicin, other anthracyclines, Navelbine, or platinum-based therapy
  • ✕Pregnant or breast-feeding women
  • ✕Serious illness or significant medical/psychiatric condition
  • ✕Uncontrolled infections

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

Search/NCT00148668
NCT00148668Phase 2Completed
CompareCT.gov

A Randomized Phase II Study of Preoperative Herceptin/Navelbine Versus Taxotere/Carboplatin/Herceptin in Early Stage, HER-2 Positive Breast Cancer

Eric Winer, MD·interventional·Posted Sep 8, 2005·Updated Apr 9, 2013

In Brief

A Phase 2 clinical trial evaluating Herceptin, Navelbine, and 2 other interventions for Breast Cancer. Completed, enrolled 81 participants across 4 sites.

Detailed Summary

The purpose of this study is to find out what effects the preoperative combination therapies of herceptin/navelbine or herceptin/taxotere/carboplatin will have on patients with early stage HER-2 positive breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsDana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital, Beth Israel Deaconess Medical Center, Yale University

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 8, 2005
Enrollment StartDec 1, 2003
Primary CompletionJan 1, 2009
Study CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 20.8 years ago

Interventions

Herceptindrug

One dose given followed by an MRI, then weekly injections beginning week 3 and ending week 14.

Navelbinedrug

Weekly injections given starting week 3 and ending week 14

Taxoteredrug

Given every three weeks starting week 3 and ending on week 14

Carboplatindrug

Given every three weeks starting week 3 and ending on week 14