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Gemcitabine Combinations in Metastatic Breast Cancer (MBC), 1st Line

NCT00191854 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2010-03-02

Study results available
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Summary

The gemcitabine-paclitaxel and gemcitabine-platinum combinations have shown promise in the treatments of MBC; however, the optimal dosing schedules for these combinations have not yet been determined. The primary objective of this study is to compare the response rates of the gemcitabine-paclitaxel, gemcitabine-carboplatin, and gemcitabine-cisplatin combinations when administered on a biweekly schedule in metastatic breast cancer.

Conditions

Interventions

DRUG

gemcitabine

2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles

DRUG

paclitaxel

150 mg/m2, IV, every 14 days x 8 cycles

DRUG

carboplatin

Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles

DRUG

cisplatin

50 mg/m2, IV, every 14 days x 8 cycles

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Monday-Friday 9:00 AM to 5:00 PM Est Time (UTC/GMT - 5 hours) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2008-08-31
Completion
2009-11-30

Countries

  • Brazil
  • China
  • India
  • Mexico
  • South Korea
  • Turkey (Türkiye)

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 NCT00191854 on ClinicalTrials.gov