COMPARATIVE STUDY OF PHASE II OF GEMCITABIN + PACLITAXEL IN PATIENTS WITH ADVANCED BREAST CANCER

Not Applicable

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

• Registration Number: PER-048-00
• Lead Sponsor: ELI LILLY INTERAMERICA INC.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2000-08-11
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

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

Inclusion Criteria

• Histological or cytological diagnosis of breast carcinoma.
• Two-dimensionally measurable advanced and / or metastatic disease.
• Patients may have received adjuvant with anthracyclines, but should not have received chemotherapy treatment for advanced disease.
• They may have received multiple lines of hormone treatment.
• Prior radiotherapy allowed provided that the irradiated area is not the only source of measurement of the disease.
• Activity level from 0 to 2 on the Zubrod scale
• Performance Status 0 or 1 on the Zubrod Performance Scale).
• Adequate adequate bone marrow reserve: leukocyte count (WBC)> 3000 X 10 6 / L, platelets> 100,000 x 10 6 / L and hemoglobin> 10g / dL
• Calcium within 10% of normal limits.
• Expected life expectancy of at least 12 weeks.
• Patient compliance and geographical proximity that allow adequate follow-up.
• Patient´s duly signed Informed Consent.
• Written informed consent of the patient.
• Age> 21 years.
• If patient is of childbearing age,pregnancy prevention measures should be used.

Exclusion Criteria

• For at least 4 weeks before the start of the study, no other form of antineoplastic treatment such as neoadjuvant chemotherapy or radiation has been received. Patients must have recovered from any significant toxicity associated with the most recent treatment.
• Hepatic insufficiency: bilirubin 2.0 times higher than normal; ALT / AST 3 times above the normal maximum limit.
• Renal insufficiency: creatinine 2 times higher than normal.
• Pregnancy or the absence of birth control methods during the study.
•Lactation
• Active heart disease requiring treatment for insufficiency, angina and / or arrhythmias; infarcts during the previous 6 months (exception: any patient whose heart failure is compensated with medication).
• Severe pulmonary disease or significant peripheral vascular disease.
• Significant neurological (such as seizures) or psychiatric disorders.
• Bone metastatic disease (with the exception of pure lesions greater than or equal to 2 cm in diameter clearly visible and measurable in simple Rx), pleural effusion or ascites as the only manifestation of the disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>Outcome name:Tumor measurement<br>Measure:Efficacy<br>Timepoints:Tumor measurements should be made before the start of treatment and before the third cycle. From the third cycle, measurements must be made every other cycle.<br>

Secondary Outcome Measures

Name	Time	Method
<br>Outcome name:Any severe adverse effects related to the use of the drugs must be reported immediately by fax through the Adverse Effects of the Study Information Form.<br>Measure:Safety<br>Timepoints:Patients will be questioned at least once before each cycle regarding the appearance and the nature of any adverse effects during the elapsed cycle.<br>