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OpenTrials
Completed

NCT Number: NCT00072865

Pemetrexed and Carboplatin in Locally Advanced or Metastatic Breast Cancer

This is a nonrandomized study of pemetrexed plus carboplatin, with the primary objective of determining the efficacy of the combination in tumor reduction, in patients with locally advanced or metastatic breast cancer.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms 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 9 AM - 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician, Moscow, Russia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologic or cytologic diagnosis of locally advanced or metastatic breast cancer
  • No prior chemotherapy for locally advanced or metastatic breast disease.
  • Patient may have received prior adjuvant therapy finished greater than 1 year prior to enrollment.
  • Adequate bone marrow, liver and kidney function
  • RECIST criteria for disease status

Exclusion criteria

  • Prior treatment with pemetrexed
  • Pregnant or breast feeding
  • Brain Metastasis
  • unable or unwilling to take folic acid, vitamin B12 supplementation, or dexamethasone.

Treatment and study plan

Pemetrexed

Drug

carboplatin

Drug

Primary outcomes

  1. antitumor activity

Secondary outcomes

  1. duration of response;time to progressive disease;time to treatment failure

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Phase II Study of Alimta and Carboplatin in the Treatment of Patients With Locally Advanced or Metastatic Breast Cancer

Important dates

Study start
2003
Study completion
2005
First posted
Nov 13, 2003
Registry last updated
Jan 26, 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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