Trial intelligence / Profile preview

Pilot Trial of Doxorubicin and Paclitaxel Sequence in Locally Advanced Breast Cancer

NCT00003035Phase 2

Key facts

Status
Completed
Start
Mar 1997
Primary completion
Jun 2001
Countries
1
Sponsor
Georgetown University
Modality
DNA Intercalators/Alkylators
Conditions
breast cancer
01

Overview

Phase 2, randomised, open-label trial of doxorubicin and paclitaxel in breast cancer (2 arms), sponsored by Georgetown University. Primary endpoints: Feasibility of obtaining serial biopsies and Feasibility of performing assays of apoptosis. Started Mar 1997; status: completed.

02

Design

2 arms
Study design
RandomizedOpen-label
  • Doxorubicin -> Paclitaxel

    Doxorubicin followed by Paclitaxel

  • Paclitaxel -> Doxorubicin

    Paclitaxel followed by Doxorubicin

03

Who it enrols

Women with histologically proven locally advanced breast cancer (unresected T3 or T4, or T2 if candidate for neoadjuvant). Patients must have adequate bone marrow, hepatic, renal, and cardiac function.

04

Endpoints

Primary

  • Feasibility of obtaining serial biopsies

  • Feasibility of performing assays of apoptosis

Secondary

  • Clinical Response Rate

  • Pathologic Response Rate

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