14F7 MAb marked with Tc99 Phase II in breast tumors.

Phase 2

• Conditions: Metastatic breast tumors.; Breast Neoplasms; Breast Diseases

• Registration Number: RPCEC00000024
• Lead Sponsor: Center of Molecular Immunology (CIM)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-29
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

1)Patients giving their consent (to participate in the clinical trial) in writing. 2)Patients with breast carcinoma phase IV upon diagnosis or evolving metastatic disease, with cyto-histological confirmation of base disease and metastasis by imaging or cyto-histological test. 3)Patients aged between 18 and 80 both inclusive. 4)Patients with general condition lower than or equal to 2, according to WHO criteria. 5)Preserved kidney function with normal creatinine values ranking from 35 to 132mmol/l. 6)Patients with hemoglobin values over 10g/l, leucocytes over 4,000 /mm3, platelets 100 x 109, transaminase and alkaline phosphatase up to 2.5 times over normal reference values.

Exclusion Criteria

1)Pregnancy or breastfeeding. 2)Reproductive-age patients not using contraceptives. 3)Feverish condition due to acute or serious infectious diseases or convalescence (not exceeding 37.5 oC). 4)Patients who have suffered from decompensated chronic diseases such as asthma, ischemic cardiopathy, diabetes mellitus, hepatitis or high blood pressure. 5)Patients with acute allergic conditions or severe allergic reaction history. 6)Patients who have previously been on some murine or humanized MAb.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Toxicity. Measuring time: 24 hours.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics, biodistribution, internal dosage and gammagraphic positive tests. Measuring time: 24 hours.