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

Immuno gamma scanning with 99mTc-marked 14F7 MaB in patients with metastatic breast tumor

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000025

Enrollment

Registered

2008-12-27

Start date

2005-10-29

Completion date

Unknown

Last updated

2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic breast tumor

Interventions

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 hav

Radionuclide Imaging

Radioimmunodetection

Antibodies, Monoclonal

Administration, Intravenous

Radioisotopes

Injections, Intra-Arterial

AcM 14F7, Immunoscintigraphy

Eligibility

Sex/Gender

Female

Age

18 Years to 80 Years

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
Gamma graphic positivity, Measuring time: 24 hours.	—

Secondary

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

Countries

Cuba

Contacts

Public ContactAngel Casaco Parada

Center of Molecular Inmunology (CIM)

casaco@cim.sld.cu

Outcome results

None listed

Source: RPCEC (via WHO ICTRP) · Data processed: Apr 4, 2026