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OpenTrials
Completed

NCT Number: NCT00191438

Phase III Study of Gemcitabine Plus a Cytotoxic Agent Versus Two Cytotoxic Agents

This is a phase III randomized study which compares two different regimens of chemotherapy. The purpose of the study is to determine which of the two regimens will make the tumor smaller or disappear, and for how long. In addition the disease-related symptoms will be evaluated. The safety of the drugs will be determined based upon evaluation of the side effects

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., Saint-Herblain, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Locally advanced and/or metastatic breast cancer.
  • Measurable disease
  • Previously treated with anthracycline

Exclusion criteria

  • Patients with inflammatory breast disease

Treatment and study plan

Gemcitabine

Drug

Capecitabine

Drug

docetaxel

Drug

Primary outcomes

  1. Progression free survival. The final analysis will occur when 250 patients have progressed or died.

Secondary outcomes

  1. Overall toxicity

  2. Quality of Life

  3. Overall Survival

  4. Overall Response Rate

  5. Time to Treatment Failure

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Phase III Study of Docetaxel in Combination With Gemcitabine Versus Docetaxel in Combination With Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer

Important dates

Study start
2002
Study completion
2007
First posted
Sep 19, 2005
Registry last updated
May 28, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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