99mTc-marked 14F7 MaB in metastatic breast, phase II

• Register: RPCEC
• Last refreshed on: 27 May 2013
• Main ID: RPCEC00000025
• Date of registration: 27/12/2008
• Primary sponsor: Center of Molecular Inmunology (CIM)
• Public title: 99mTc-marked 14F7 MaB in metastatic breast, phase II
• Scientific title: Immuno gamma scanning with 99mTc-marked 14F7 MaB in patients with metastatic breast tumor
• Date of first enrolment: 29/10/2005
• Target sample size: 21
• Recruitment status: Active
• URL: http://registroclinico.sld.cu/trials/RPCEC00000025-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Single Group Purpose: Diagnostic

Countries of recruitment

Cuba

Contacts

• Name: Angel Casaco Parada
• Affiliation: Center of Molecular Inmunology (CIM)

• Name: Angel Casaco Parada
• Affiliation: Center of Molecular Inmunology (CIM)

Key inclusion & exclusion criteria

Inclusion criteria: 1) Patients giving their consent in writing to participate in the clinical trial. 2) Patients with breast carcinoma, phase IV upon diagnosis, or evolving metastatic disease, with cyto-histological confirmation of base disease and of metastasis by imaging and cyto-histological tests. 3) Patients aged 18 to 80. 4) Patients whose general condition is lower than or equal to 2 under WHO criteria. 5) Preserved kidney function with creatinine values within normal limits (35-132 mmol/L). 6) Patients with hemoglobin values over 10g/L, leucocytes over 4,000/mm3, platelets 100 x 109, and transaminase and alkaline phosphatase up to 2.5 times higher than normal reference values. 7) Female patients will be included in the study.
Exclusion criteria: 1) Pregnancy and breastfeeding. 2) Reproductive-age patients not using contraceptive methods. 3) Fever due to acute or serious infectious diseases or convalescence (not exceeding 37.5oC). 4) Patients with history of uncontrolled chronic diseases such as asthma, ischemic cardiopathy, diabetes mellitus, hepatitis, and high blood pressure. 5) Patients with allergic conditions or history of severe allergic reactions. 6) Patients who have previously been on any murine or humanized MAb therapy.

Age minimum: 18 years
Age maximum: 80 years
Gender: Female

Health Condition(s) or Problem(s) studied

Metastatic breast tumor

Intervention(s)

One single 1-mg dose of 30-40mCi of 99mTc-marked 14F7 MaB will be administered intravenously within 1-2 minutes, volume exceeding 1mL. Patients with metastasis located in contralateral breast will have the product administered through pedis artery.

Primary Outcome(s)

Gamma graphic positivity, Measuring time: 24 hours.

Secondary Outcome(s)

Concordance degree, sensitivity, specificity, predictive positive value, predictive negative value, and Toxicity. Measuring time: 24 hours.

Secondary ID(s)

IIC RD-EC073

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable