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OpenTrials
Completed

NCT Number: NCT00097383

Study of Alimta and Epirubicin Administered in Patients With Locally Advanced or Metastatic Breast Cancer

This is a non-randomized Phase 2 portion of a study testing ALIMTA and epirubicin in combination for locally advanced or metastatic breast cancer. Epirubicin is a well-established drug for the therapy of breast cancer. Both ALIMTA and epirubicin have been combined with other drugs but they have not yet been combined with each other. It is expected that the patient will benefit from the different mechanisms of action of the two drugs.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms 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 1 / Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY (1-877-285-4559) or speak with your personal physician., La Plata, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of locally advanced or metastatic breast cancer not amenable to local treatment.
  • Patients must be chemo-naive or have only neoadjuvant and/or adjuvant chemotherapy.
  • Patients must have at least one measurable lesion in an area not previously irradiated.
  • No chemotherapy at least 4 weeks prior to study enrollment.
  • Signed informed consent from patient.

Exclusion criteria

  • Treatment with any drug within the last 30 days that has not received regulatory approval.
  • Serious systemic disorders, including active infection.
  • Significant cardiovascular disease.
  • Pregnancy or breast feeding.
  • Inability or unwillingness to take folic acid or Vitamin B12 supplementation.

Treatment and study plan

ALIMTA plus Epirubicin

Drug

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2 Study of Alimta and Epirubicin Administered Every 21 Days in Patients With Locally Advanced or Metastatic Breast Cancer

Important dates

First posted
Nov 23, 2004
Registry last updated
Jul 19, 2006

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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