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

Immuno gamma scanning using 14F7 MAbB marked with Tc99 in patients with metastatic breast tumor, phase II.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

RPCEC

Registry ID

RPCEC00000024

Enrollment

Registered

2010-12-29

Start date

2003-02-13

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 tumors.

Interventions

One single 1mg dose of 14F7 MaB marked with 30-40mCi of 99mTc will be administered intravenously within 1-2 minutes (volume over 1 ml). Patients with metastasis in contralateral breast will have the p

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 (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

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.

Design outcomes

Primary

Measure	Time frame
Toxicity. Measuring time: 24 hours.	—

Secondary

Measure	Time frame
Pharmacokinetics, biodistribution, internal dosage and gammagraphic positive tests. Measuring time: 24 hours.	—

Countries

Cuba

Contacts

Public ContactAngel Casaco Parada

Center of Molecular Immunology (CIM)

casaco@cim.sld.cu

Outcome results

None listed

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