Pemetrexed-Carboplatin and Gemcitabine-Vinorelbine in Advanced Breast Cancer

Inclusion Criteria

• •Females with histologic or cytologic diagnosis of advanced breast cancer. Lesions should not be amenable to surgery or radiation of curative intent.
• •Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) performance status scale.
• •One prior chemotherapy containing anthracyclines as (neo)adjuvant or palliative 1st-line treatment.
• •One prior chemotherapy containing taxanes as (neo) adjuvant or palliative 1st-line treatment.
• •Prior radiation therapy is allowed to less than 25% of the bone marrow. Participants must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed 30 days before study entry. Lesions that have been radiated cannot be included as sites of measurable disease unless clear tumor progression has been documented in these lesions since the end of radiation therapy.
• •At least one uni-dimensionally measurable lesion meeting Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Positron emission tomography \[PET\] scans and ultrasounds may not be used.
• •Antitumoral hormonal treatment must be discontinued prior to enrollment.
• •Estimated life expectancy of at least 3 months.
• •Participant compliance and geographic proximity that allow adequate follow-up.
• •Adequate organ function
• •Female participants of childbearing potential must test negative for pregnancy within 7 days of enrollment based on a urine and/or serum pregnancy test and agree to use a reliable method of birth control during and for 6 months following the last dose of study drug.
• •Participants must sign an informed consent document.
• •Female participants must be at least 18 years of age.