CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 110 enrolled
Drug / intervention
Gemcitabine +2 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • Histologically confirmed adenocarcinoma of the breast
  • Female, age >18 years
  • Normal cardiac function
  • Able to perform activities of daily living with minimal assistance
Key exclusion· 6
  • Life expectancy <6 months
  • History of significant heart disease
  • Prior chemotherapy or hormonal therapy (within 5 years)
  • Concurrent trastuzumab therapy

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

Search/NCT00193050
NCT00193050Phase 2Completed

Phase II Trial of Induction Chemotherapy With Weekly Gemcitabine, Epirubicin, Docetaxel as Primary Treatment of Locally Advanced or Inflammatory Breast Cancer Patients

SCRI Development Innovations, LLC·interventional·Posted Sep 19, 2005·Updated Oct 26, 2021

In Brief

A Phase 2 clinical trial evaluating Gemcitabine, Epirubicin, and 1 other intervention for Breast Cancer. Completed, enrolled 110 participants.

Detailed Summary

Treatment strategies that include induction chemotherapy have several potential advantages: early initiation of systemic chemotherapy, in vivo assessment of response, and down-staging of both the primary tumor and regional lymphatic metastases, making breast conservation an option for many. The aim of the present study is to determine the efficacy and toxicity of induction combination chemotherapy with the triplet, gemcitabine, epirubicin, and docetaxel, in patients with locally advanced or inflammatory breast cancer. Clearly, it is in the upfront treatment as well as in the adjuvant treatment of breast cancer, that effective new agents and combination of agents are likely to have the greatest potential impact.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
Countries--

Timeline

Phase 2CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartNov 1, 2001
Primary CompletionMar 1, 2008
Study CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 20.8 years ago

Interventions

Gemcitabinedrug

Gemcitabine

Epirubicindrug

Epirubicin

Docetaxeldrug

Docetaxel