EVALUATION OF THE CORRELATION BETWEEN THE CLINICAL RESPONSE TO ALIMTA AND THE MOLECULAR LEVELS IN PATIENTS WITH ADVANCED BREAST CANCER

Not Applicable

• Conditions: -C50 Malignant neoplasm of breast; Malignant neoplasm of breast; C50

• Registration Number: PER-001-01
• Lead Sponsor: ELI LILLY INTERAMERICA INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2001-01-01
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

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.
or Hepatic: bilirubin <1.5 times the normal limit (x ULN), alkaline phosphatase (AP), aspartate transaminase (AST) and alanine transaminase (ALT) <3.0 x ULN.
o Renal: Clearance (clearance) of calculated creatinine (CrCl)> 45 mL / min using only the body mass formula (Cockcroft and Gault)
• Informed Consent signed by the patient.
• Women at least 18 years of age.
• Patients with reproductive potential should use a contraceptive method if necessary (for example, intrauterine device [IUD], or barrier device) during and for 3 months after the study. Oral contraceptives should be discontinued at least 3 weeks before the enrollment, and not used during study therapy.
• Patients must be able to tolerate surgical procedures according to the recommendation of their doctors and descriptions of this protocol.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Physical exam, Tumor measurement (visible or palpable), radiological tests for tumor measurements, biochemistry and hematology tests<br>Measure:The correlation between expression levels of TS, DHFR, GARPT, p53 and erbB2, in breast cancer and normal tissues, and the patients response to ALIMTA therapy.<br>Timepoints:Within 10 days of enrollment in the study, then +3 days on Day 8, within 4 days before each cycle, and if possible in the poststudy visit<br>