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OpenTrials
Completed

NCT Number: NCT00102219

A Study of Pemetrexed Plus Doxorubicin Given to Patients With Advanced Breast Cancer

This is a non-randomized Phase 2 study testing pemetrexed and doxorubicin in combination for locally advanced or metastatic breast cancer. Both pemetrexed and doxorubicin 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. However, there is no guarantee that the patient will benefit from this treatment.

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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 2

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 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Belo Horizonte, BH, Brazil

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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 that is not amenable to local treatment.
  • Patients must be chemo-naive or have received only neoadjuvant and/or adjuvant chemotherapy.
  • At least one measurable lesion.
  • No chemotherapy within 4 weeks prior to enrollment.
  • Signed informed consent from the patient.

Exclusion criteria

  • Prior chemotherapy for metastatic breast cancer.
  • Prior treatment with any anthracyclines or anthracenedione-containing regimen.
  • Treatment within the last 30 days with any drug that has not received regulatory approval.
  • Pregnancy and/or breast feeding.
  • Inability or unwillingness to take folic acid or vitamin B12 supplementation.

Treatment and study plan

Pemetrexed

Drug

Doxorubicin

Drug

Primary outcomes

  1. To assess the antitumor activity of pemetrexed plus doxorubicin, as measured by overall tumor response rate

Secondary outcomes

  1. Time to progressive disease

  2. Progression-free survival

  3. Overall survival

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase 2 Study of ALIMTA Plus Doxorubicin Administered Every 21 Days in Patients With Advanced Breast Cancer

Important dates

Study start
2004
Study completion
2007
First posted
Jan 26, 2005
Registry last updated
Nov 30, 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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