Trial intelligence / Profile preview

Camptosar in metastatic breast cancer

NCT00004182Phase 2

Key facts

Status
Completed
Start
Oct 1999
Primary completion
Apr 2000
Countries
1
Sponsor
Northwestern University
Modality
Small Molecules
Conditions
breast cancer
01

Overview

Phase 2, open-label, single-arm trial of irinotecan in breast cancer, sponsored by Northwestern University. Primary endpoint: Objective Response Rate. Started Oct 1999; status: completed.

02

Design

1 arm
Study design
Non-randomizedOpen-labelSingle group
  • Irinotecan Monotherapy

    Patients receive irinotecan IV over 90 minutes weekly for 4 weeks. Treatment repeats every 6 weeks.

03

Who it enrols

Patients with histologically proven advanced breast cancer who have received prior anthracycline and taxane based chemotherapy, with measurable disease and no CNS metastases.

04

Endpoints

Primary

  • Objective Response Rate

Secondary

  • Toxicities

  • Survival Time

  • Duration of Response

  • Time to Treatment Failure

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