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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00106002 |
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Date of registration:
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18/03/2005 |
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Primary sponsor: |
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Public title:
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Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer
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Scientific title:
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A Phase II Study of Alimta as First Line Chemotherapy for Advanced or Metastatic Breast Cancer |
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Date of first enrolment:
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April 2005 |
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Target sample size:
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37 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00106002 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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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) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Eli Lilly and Company |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Must have been diagnosed with either advanced or metastatic breast cancer.
- Chemotherapy has not been given for advanced or metastatic breast cancer.
- The diagnosis of advanced or metastatic breast cancer was made at least 12 months
after chemotherapy was given after breast surgery.
- Able to carry out work of a light nature (for example, light housework, office work).
- Must be at least 18 years old.
Exclusion Criteria:
- Have received prior bone marrow or peripheral stem cell transplantation.
- Have received prior chemotherapy for metastatic breast cancer.
- Are currently pregnant or breast-feeding.
- Have an active infection that your doctor decides will affect your safety.
- Are unable to take folic acid or vitamin B12.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Breast Neoplasms, Male
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Carcinoma, Ductal
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Intervention(s)
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Drug: pemetrexed
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Primary Outcome(s)
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Overall Tumor Response
[Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression]
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Secondary Outcome(s)
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Duration of Tumor Response
[Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression]
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Overall Survival Time
[Time Frame: every 14 day cycle, during 30-days post-therapy follow-up, and every 6 months during the long-term follow-up]
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Progression-Free Survival Time
[Time Frame: every 3 cycles (approximately 6-7 weeks) or until patient has disease progression]
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Toxicity Profile: Adverse Events (Common Terminology Criteria for Adverse Events, Grade 3 and 4, Present in >5% of Participants)
[Time Frame: every 14 day cycle, and during 30-days post-therapy follow-up and long-term follow-up]
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Secondary ID(s)
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9028
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H3E-US-S045
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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