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Study of Two Doses of ALIMTA (Pemetrexed) as First Line Chemotherapy for Advanced Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

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Trial Information

Study of Two Doses of ALIMTA (Pemetrexed) as First Line Chemotherapy for Advanced Breast Cancer

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

To assess tumor response.

Principal Investigator

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)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


United States: Food and Drug Administration

Study ID:




Start Date:

May 2003

Completion Date:

June 2005

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms