CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 84 enrolled
Drug / intervention
pegylated liposomal doxorubicin hydrochloride +3 moredrug
Likely dose
Pegylated liposomal doxorubicin (Doxil) IV, docetaxel (Taxotere) IV, and trastuzumab (Herceptin) IV; specific doses not stated in protocol excerptAI-extracted
Key inclusion· 7
  • Histologically confirmed adenocarcinoma of the breast with metastatic disease
  • HER2 expression status must be determined by ECOG Pathology Coordinating Office; will be used at registration
  • ECOG performance status 0, 1, or 2
  • Normal left ventricular ejection fraction at or above institutional lower limits of normal
Key exclusion· 9
  • Prior chemotherapy for advanced/metastatic disease
  • Prior adjuvant anthracycline or any anthracycline-containing regimen, or any anthracenedione-containing regimen
  • Prior therapy with Herceptin (trastuzumab)
  • Extensive prior radiotherapy (>25% marrow-containing bone or prior photon internal mammary node treatment)

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

Search/NCT00004888
NCT00004888Phase 2Completed

A Safety and Efficacy Study of Doxil and Taxotere ± Herceptin in Advanced Breast Cancer

National Cancer Institute (NCI)·interventional·Posted Jan 27, 2003·Updated May 23, 2014

In Brief

A Phase 2 clinical trial evaluating pegylated liposomal doxorubicin hydrochloride, docetaxel, and 2 other interventions for Recurrent Breast Cancer and Stage IV Breast Cancer. Completed, enrolled 84 participants across 1 site.

Detailed Summary

Phase II trial to study the effectiveness of combination chemotherapy with or without trastuzumab in treating women who have metastatic breast cancer. Drugs used in chemotherapy 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartJan 1, 2001
Primary CompletionApr 1, 2008
Study CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7.3 yearsPosted 23.4 years ago

Interventions

pegylated liposomal doxorubicin hydrochloridedrug

Given IV

docetaxeldrug

Given IV

trastuzumabbiological

Given IV

laboratory biomarker analysisother

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