PER-001-01
Completed
未知
EVALUATION OF THE CORRELATION BETWEEN THE CLINICAL RESPONSE TO ALIMTA AND THE MOLECULAR LEVELS IN PATIENTS WITH ADVANCED BREAST CANCER
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- -C50 Malignant neoplasm of breast
- Sponsor
- ELI LILLY INTERAMERICA INC.,
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Suspected or confirmed breast cancer (the diagnosis must be confirmed before the first administration of ALIMTA). The disease will be classified as T3 or T4 and NO, NI, or N2\.
- •The condition of the disease must be that measurable disease defined as:
- •Two\-dimensionally measurable lesions with clear margins defined by any of the following:
- •o Computed tomography (CT), magnetic resonance imaging (MRI) or other image scans (except bone scan) with both diameters greater than the distance between the slices of the imaging study.
- •or palpation, with both diameters greater than or equal to 2 cm, together with an adequate imaging procedure.
- •70 to more activity status in the Kamofsky Scale.
- •Estimated Life Expectancy of at least 12 weeks.
- •Suitability of the patient and geographical proximity that allows an appropriate follow\-up.
- •Adequate functioning of the organ, including the following:
- •o Adequate reserve of bone marrow: absolute neutrophil count (segmented abraded), Absolute Neutrophil Count (ANC)\> 1\.5 X 10 9 / L, platelets\> 100 x 10 9 / L, and hemoglobin\> 9 g / dL.
Exclusion Criteria
- •Treatment with any drug in the last 30 days that has not received regulatory approval at the time of entering the study.
- •Any previous or concomitant antitumor therapy (such as cytotoxic, hormonal, or radiotherapy)).
- •Patients must have discontinued the use of any steroid medication no less than 3 weeks prior to enrollment.
- •Pregnancy or breastfeeding.
- •Serious concomitant systemic disorders, including active infection that could compromise patient safety or the patient´s ability to complete the study, at the discretion of the investigator.
- •Second primary neoplasm (except in situ carcinoma of the cervix or carcinoma to the non\-melanoma skin adequately treated or another neoplasm treated at least 5 years previously, without evidence of relapse).
- •Inability to discontinue aspirin or other non\-steroidal anti\-inflammatory agents 2 days before, the day of, or two days after the dose of ALIMTA (5 days before for long\-acting agents such as piroxicam)
- •Presence of clinically detectable fluid collection (by physical examination); for example, ascites or pleural effusions (collection of fluids may be by drainage to allow the patient to enroll in the study).
- •Significant weight loss (for example,\> 10%). if known, in the last 6 weeks before entering the study.
- •Inability to take folic acid or Vitamin B12 supplement.
Outcomes
Primary Outcomes
Not specified
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