CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 72 enrolled
Drug / intervention
filgrastim +6 morebiological
Likely dose
Doxorubicin (Adriamycin), cyclophosphamide (Cytoxan), and paclitaxel (Taxol) in ACT regimen, or cyclophosphamide, thiotepa, and carboplatin (STAMP V) in STAMP V regimen, followed by autologous peripheral blood stem cell transplantationAI-extracted
Key inclusion· 6
  • ✓Histologically proven high-risk primary breast cancer with <60% chance of 3-year progression-free survival
  • ✓Stage II breast cancer with at least 10 positive axillary nodes, OR stage IIIA or IIIB
  • ✓Age 60 years or younger
  • ✓Karnofsky performance status 80-100%
Key exclusion· 11
  • ✕CNS metastasis
  • ✕Histologically proven bone marrow metastasis
  • ✕Prior doxorubicin exceeding 240 mg/m²
  • ✕Prior paclitaxel ≥750 mg/m²

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

Search/NCT00004092
NCT00004092Phase 2Completed
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Randomized Phase II Study of Adriamycin/Cytoxan/Taxol (ACT) vs. Cytoxan, Thiotepa, Carboplatin (STAMP V) in Patients With High-Risk Primary Breast Cancer

City of Hope Medical Center·interventional·Posted Jan 27, 2003·Updated Aug 4, 2015

In Brief

A Phase 2 clinical trial evaluating filgrastim, carboplatin, and 5 other interventions for Breast Cancer. Completed, enrolled 72 participants across 2 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This randomized phase II trial is studying two different regimens of combination chemotherapy and comparing them to see how well they work in treating patients with high-risk primary stage II or stage III breast cancer.

Study Details

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

Timeline

Phase 2CompletedFinished
19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 27, 2003
Enrollment StartMay 1, 1999
Primary CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 14.6 yearsPosted 23.4 years ago

Interventions

filgrastimbiological

Given IV or subcutaneously

carboplatindrug

Given IV

cyclophosphamidedrug

Given IV

doxorubicin hydrochloridedrug

Given IV

paclitaxeldrug

Given IV

thiotepadrug

Given IV

peripheral blood stem cell transplantationprocedure

Patients receive autologous peripheral blood stem cells