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Pemetrexed as First Line Chemotherapy for Advanced Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00065533
Recruitment Status : Completed
First Posted : July 29, 2003
Last Update Posted : June 22, 2007
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE July 28, 2003
First Posted Date  ICMJE July 29, 2003
Last Update Posted Date June 22, 2007
Study Start Date  ICMJE May 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2007)
To assess tumor response.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 21, 2007)
  • To evaluate the toxicity profile of two doses of pemetrexed in breast cancer patients.
  • To assess the following time-to-event efficacy variables: time to response, duration of response, duration of stable disease, time to documented progressive disease, time to treatment failure, progression-free survival, and overall survival.
  • To identify the relationships, if any, that may exist between various molecular markers and pemetrexed efficacy and toxicity.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Pemetrexed as First Line Chemotherapy for Advanced Breast Cancer
Official Title  ICMJE Study of Two Doses of ALIMTA (Pemetrexed) as First Line Chemotherapy for Advanced Breast Cancer
Brief Summary The purposes of this study are to determine the safety of pemetrexed and any side effects that might be associated with it, whether pemetrexed can help patients with breast cancer and how much pemetrexed should be given to patients.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Drug: pemetrexed
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 21, 2007)
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Be at least 18 years of old.
  • Have been diagnosed with breast cancer
  • At least one year disease-free interval after initial treatment.
  • Have pre-study laboratory tests that are within the requirements of this study.
  • Be able to visit the doctor's office weekly during the treatment period.

Exclusion Criteria:

  • To be pregnant or breastfeeding.
  • To be currently taking aspirin or aspirin- like medicine and unable to stop for a few days during each cycle of therapy.
  • To have received prior chemotherapy for the treatment of metastatic cancer. Patients may have received prior hormonal treatment.
  • To have another illness that your doctor thinks would make you unable to participate.
  • To be unable or not willing to take folic acid and vitamin B12.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Belgium,   Germany,   Romania,   Spain,   United Kingdom
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00065533
Other Study ID Numbers  ICMJE 7491
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date June 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP