Pemetrexed as First Line Chemotherapy for Advanced Breast Cancer

Lilly

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: pemetrexed

Study type

Interventional

Funder types

Industry

Identifiers

NCT00065533

7491

H3E-MC-JMGE

Details and patient eligibility

About

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.

Enrollment

92 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.