CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 41 enrolled
Drug / intervention
filgrastim +10 morebiological
Likely dose
Cisplatin, cyclophosphamide, doxorubicin hydrochloride, melphalan, mesna, and paclitaxel (with filgrastim support) followed by peripheral blood stem cell transplantation after bone marrow ablationAI-extracted
Key inclusion· 8
  • ✓Histologically proven stage IIIB breast cancer with dermal/epidermal invasion or clinical features of inflammation (erythema, pain, hypersensitivity, edema, or skin thickening)
  • ✓Diagnosis within the past 6 months
  • ✓Age 60 years or younger
  • ✓Karnofsky performance status 80-100%
Key exclusion· 9
  • ✕Age >60 years
  • ✕History of malignant disease in the past 5 years, except squamous/basal cell skin cancer or stage I/in situ cervical cancer
  • ✕Organic CNS dysfunction
  • ✕Known and potentially disabling psychosocial history

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

Search/NCT00003042
NCT00003042Phase 2Completed
CompareCT.gov

Dose-Intense Chemotherapy and Stem Cell Rescue in the Treatment of Inflammatory Breast Carcinoma

City of Hope Medical Center·interventional·Posted Jan 27, 2003·Updated Feb 20, 2026

In Brief

A Phase 2 clinical trial evaluating filgrastim, cisplatin, and 9 other interventions for Breast Cancer. Completed, enrolled 41 participants across 1 site.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase II trial is studying how well chemotherapy and stem cell transplantation work in treating patients with stage IIIB breast cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 2CompletedFinished
1997199819992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartMay 30, 1997
Primary CompletionFeb 9, 2010
Study CompletionNov 6, 2025
TodayJul 2, 2026
Enrollment to primary: 12.7 yearsPosted 23.4 years ago

Interventions

filgrastimbiological

cisplatindrug

cyclophosphamidedrug

doxorubicin hydrochloridedrug

melphalandrug

mesnadrug

paclitaxeldrug

tamoxifen citratedrug

bone marrow ablation with stem cell supportprocedure

conventional surgeryprocedure

peripheral blood stem cell transplantationprocedure