Advanced breast cancer treatment with hR3 monoclonal antibody combined with doxorubicin and cyclophosphamide, phase I.

• Register: RPCEC
• Last refreshed on: 27 May 2013
• Main ID: RPCEC00000057
• Date of registration: 17/12/2010
• Primary sponsor: Center of Molecular Immunology (CIM)
• Public title: Advanced breast cancer treatment with hR3 monoclonal antibody combined with doxorubicin and cyclophosphamide, phase I.
• Scientific title: Advanced breast cancer treatment with hR3 monoclonal antibody combined with doxorubicin and cyclophosphamide. Clinical trial, phase I.
• Date of first enrolment: 13/10/2005
• Target sample size: 15
• Recruitment status: Closed
• URL: http://registroclinico.sld.cu/trials/RPCEC00000057-En
• Study type: Interventional
• Study design: Randomization: N/A: single arm study. Blinding: Open. Placebo: Uncontrolled Assignment: Other Purpose: Treatment Other design features: Dose escalation

Countries of recruitment

Cuba

Contacts

• Name: Mayra Ramos Suzarte
• Affiliation: Center of Molecular Immunology (CIM)

• Name: Mayra Ramos Suzarte
• Affiliation: Center of Molecular Immunology (CIM)

Key inclusion & exclusion criteria

Inclusion criteria: 1)Female patients with histologically confirmed breast cancer. 2)Patients with breast cancer, stage III or IV. 3)Patients should not have been on oncological treatment in the last 4 weeks prior to this treatment. 4)Age >18. Children are not included in the study because there are no data available in connection with adverse events and hR3 MaB dosage combined with doxorubicin and cyclophosphamide in patients under 18 years of age. 5)General condition ECOG <2 (Karnofsky >60%). 6)Life expectancy over 6 months. 7)Patient’s organs and bone marrow should be working normally, as defined by the following parameters: leucocytes >3,000/ul, absolute neutrophil count >1,500/ul, platelets >100,000/ul, total bilirubin within normal limits, TGO/TGP 60 mL/min/1.73 m2 on patients with creatinine values higher than the normal values established by the institution. 8)Patients with HER1+tumors (EGF positive receptor) determined by immunohistochemical techniques. 9)The effect of hR3 monoclonal antibody on human fetuses under development is unknown. Considering this and the fact that chemotherapy can also be teratogenic, reproductive age women should use appropriate contraceptive methods (barrier, hormone or abstinence) before and during the clinical trial. Reproductive age female patients should also be pregnancy-tested negative. If a patient gets pregnant or believes she is pregnant, she should inform her doctor immediately. 10)Capacity to understand the study and readiness to sign the informed consent document.
Exclusion criteria: 1) Patients on another product under research. 2) Patients with history of allergy attributed to chemical or biological compounds similar to hR3 monoclonal antibody or the chemotherapy used in the study. 3) Patients with uncontrolled intercurrent diseases, including active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and psychiatric or social diseases hindering adherence to clinical trial requirements. 4) Pregnant patients. 5) Breastfeeding should be discontinued upon inclusion in the clinical trial because of potential and unknown adverse effects on infants. 6) Patients with anthracycline contraindications. 7) Patients with brain metastasis.

Age minimum: 19 years
Age maximum: No limit
Gender: Female

Health Condition(s) or Problem(s) studied

Advanced breast cancer

Intervention(s)

Treatment will be provided in an ambulatory fashion, except the first and tenth hR3 administrations. After these two administrations, patients should be hospitalized for four days to facilitate sample taking for pharmacokinetic trial. All patients will receive chemotherapy and the doses level of MAb that correspond. Level 1: MAb hR3 (30 mg/m2) Level 2: MAb hR3 (60 mg/m2) Level 3: MAb hR3 (115 mg/m2) Level 4: MAb hR3 (230 mg/m2) MAb will be administered intravenously (antecubital vein), in 250 ml of saline solution in rapid infusion (30 minutes). Ambulatory chemotherapy is 4 cycles every 21 days (7th, 28th, 49th, and 70th day) compound by: -Doxorubicin (60 mg/m2) - Day 1 – 4 -Cyclophosphamide (600 mg/m2)- Day 1 - 4

Primary Outcome(s)

Maximum permissible dose and/or optimal biological dose. Measuring time: 12 months

Secondary Outcome(s)

Toxicity profile, pharmacokinetics, dose-dependent changes, systemic clearing variations. Measuring time: 12 months

Secondary ID(s)

IIC RD-EC070

Source(s) of Monetary Support

Government funds

Secondary Sponsor(s)

Not applicable