CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 51 enrolled
Drug / intervention
Docetaxel +1 moredrug
Likely dose
Sequential arm: Docetaxel 100 mg/m² IV day 1 every 3 weeks for 4 cycles, followed by capecitabine 1000 mg/m² orally twice daily days 1-14 every 3 weeks for 4 cycles. Concurrent arm: Docetaxel 50 mg/m² IV day 1 and capecitabine 1000 mg/m² orally twice daily days 1-7 every 2 weeks for 8 cyclesAI-extracted
Key inclusion· 4
  • Histologically or cytologically confirmed breast carcinoma
  • Early stage breast cancer (stage 1, 2, or 3)
  • No distant metastases except ipsilateral axillary lymph nodes
  • Age 18 years or older
Key exclusion· 3
  • Prior chemotherapy, hormonal therapy, biologic therapy, or radiation therapy for breast cancer
  • Major surgery within 28 days of study entry
  • CNS metastases

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

Search/NCT00209092
NCT00209092Phase 2Completed

Randomized Phase II Trial of Sequential Docetaxel Followed by Capecitabine Versus Concomitant, Dose-Dense Docetaxel/Capecitabine as in Induction Therapy for Early Stage Breast Cancer

Emory University·interventional·Posted Sep 21, 2005·Updated Mar 27, 2015

In Brief

A Phase 2 clinical trial evaluating Docetaxel and Capecitabine for Breast Cancer. Completed, enrolled 51 participants across 19 sites.

Detailed Summary

The purpose of this study is to find out if the combination of docetaxel and capecitabine can shrink the size of breast tumors and preserve the breast.

Study Details

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

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 21, 2005
Enrollment StartAug 1, 2006
Primary CompletionJul 1, 2009
Study CompletionOct 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 20.8 years ago

Interventions

Docetaxeldrug

Sequential Therapy: Docetaxel will be given at 100 mg/m\^2 Intravenously (IV)Day 1 every 3 weeks for 4 cycles. Concurrent Therapy: Docetaxel will be given at 50 mg/m\^2 IV Day 1.

Capecitabinedrug

Sequential Therapy: administration of capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-14 every 3 weeks for 4 cycles (total 8 cycles) Concurrent Therapy: capecitabine 1000 mg/m\^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).