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Preoperative Treatment of Breast Cancer With Two Different Sequential Treatment Regimens

NCT00149214 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 257

Last updated 2012-03-21

Study results available
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Summary

An open-label randomized Phase II study in order to explore two different sequential anthracycline-based neoadjuvant treatment regimens in female patients with primary, operable breast cancer (T2-T4/N0-2/M0).

Conditions

Interventions

DRUG

pemetrexed

500 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4)

DRUG

cyclophosphamide

600 mg/m2, intravenous (IV), every 21 days, 4 cycles (1-4)

DRUG

doxorubicin

60 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (1-4)

DRUG

docetaxel

100 mg/m\^2, intravenous (IV), every 21 days, 4 cycles (5-8)

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9am - 5pm Eastern time (UTC/GMT - 5 hours, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2008-02-29
Completion
2011-03-31

Countries

  • Germany
  • Italy
  • Russia
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00149214 on ClinicalTrials.gov