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Low-dose Oral Cyclophosphamide and Methotrexate Maintenance for Hormone Receptor-negative Early Breast Cancer

NCT00022516 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1086

Last updated 2016-09-16

Study results available
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Summary

This randomized, phase III trial was designed to test the efficacy of a low-dose chemotherapy-maintenance regimen, hypothesized to have anti-angiogenic activity, administered following standard chemotherapy in patients with early breast cancer whose tumors are hormone receptor negative.

Conditions

Interventions

DRUG

Cyclophosphamide

50 mg/day orally continuously for 1 year

DRUG

Methotrexate

2.5 mg twice/day orally days 1 and 2 of every week for 1 year

Sponsors & Collaborators

  • ETOP IBCSG Partners Foundation

    lead NETWORK

Principal Investigators

  • Marco Colleoni, MD · European Institute of Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
120 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-11-30
Primary Completion
2015-01-31
Completion
2016-08-31

Countries

  • Australia
  • Belgium
  • Brazil
  • Chile
  • Hungary
  • Italy
  • Nigeria
  • Peru
  • Romania
  • South Africa
  • Switzerland

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00022516 on ClinicalTrials.gov