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

General information

Section to complete general information about the trial: scientific and public title, protocol identifiers, sponsors and Source(s) of Monetary or Material Support.

Scientific title:

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

Secondary indentifying numbers:

IIC RD-EC070

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Government funds

Authorization for beginning

Section to complete information about the regulatory approval of clinical trial: regulatory agency name, approval date and reference number in the agency.

Regulatory instance to authorize the initiation of the study:

Center for State Control of the Quality of Drugs(CECMED)

Authorization date :

21/09/2004

Reference number:

1443/06.012.06B

Principal investigator

Section to complete information about Email address, telephone number and postal address of the Principal Investigator.

First name:

Jorge

Midle name:

Luis

Last name:

Soriano Garcia

Medical Specialty :

2nd degree specialist in oncology

Affiliation:

Hermanos Ameijeiras Hospital

Postal address:

San Lazaro No. 701 esquina a Belascoain

City:

La Habana

País:

Cuba

Zip Code:

10300

Telephone:

+53-78761000

Email address:

soriano@infomed.sld.cu

Clinical sites to participate

Section to complete the data related to the clinical sites involved in the trial: site and responsible investigator for every site.

Countries of recruitment:

Cuba

Clinical sites:

Not applicable

Research ethics committees:

Hermanos Ameijeiras hospital (HHA), April 5th, 2004.

Recruitment status

Section to complete information about the recruitment status and the date of first enrolment subject

Recruitment status:

Complete

Date of first enrollment:

13/10/2005

Health condition and Intervention

Section to complete information about the primary medical condition(s) or problem(s) studied and, a characteristics of the intervention(s).

Health condition(s) or Problem(s) studied:

Advanced breast cancer

Health condition(s) code:

Breast Neoplasms

Breast Diseases

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

Intervention code:

Antibodies, Monoclonal, Humanized

Doxorubicin

Cyclophosphamide

Drug Therapy

Antibodies, Monoclonal

Infusions, Intravenous

Intervention keyword:

AcM hR3

Outcomes and Timepoint

Section to complete information about primary and secondary outcomes including. It includes the metric or method of measurement used and, the time point for every outcome.

Primary outcome(s):

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

Key secondary outcomes:

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

Selection criterias

Section to complete information about the inclusion and exclusion criteria for participant selection, including age and gender.

Gender:

Female

Minimum age:

19 years

Maximum age:

None

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.

Type of population:

Adults

Type of participant:

Patients

Study design

Section to complete information about the characteristics of the study design.

Type study:

Interventional

Purpose:

Treatment

Allocation:

N/A: single arm study

Masking:

Open

Control group:

Uncontrolled

Study design:

Other

Other design:

Dose escalation

Phase:

1

Target sample size:

15

Contact for public queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to general queries, including information about current recruitment status

First Name:

Mayra

Last Name:

Ramos Suzarte

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

(537) 271-7933 Ext 224

Email :

mayra@cim.sld.cu

Contact for scientific queries

Section to complete information about Email address, telephone number and postal address of the contact who will respond to scientific queries.

First Name:

Mayra

Last Name:

Ramos Suzarte

Affiliation:

Center of Molecular Immunology (CIM)

Postal Address:

Calle 216 Esquina 15, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

(537) 271-7933 Ext 224

Email :

mayra@cim.sld.cu

Registration and Update

Section to complete information about the name of Primary Registry, date of registration and the unique ID number assigned by the registry (RPCEC).

Primary registry:

RPCEC

Unique ID number:

RPCEC00000057

Date of Registration in Primary Registry:

2010-12-17

Record Verification Date:

2008-03-21 20:00

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

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