Phase II / III. Nimotuzumab in patients with triple-negative breast cancer.

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:

Open clinical trial, controlled for the evaluation of the efficacy and safety of using Nimotuzumab in patients with triple-negative breast cancer. Phase II / III.

Secondary indentifying numbers:

IIC RD-EC150

Issuing authority of the secondary identifying numbers:

Center of Molecular Immunology (CIM)

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM) Ministry of Public Health (MINSAP) National Coordinating of Clinical Trials (CENCEC)

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 Drugs, Medical Devices and Equipment (CECMED)

Authorization date :

14/01/2014

Reference number:

05-012-13-BC

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

Medical Specialty :

Oncologyst, Second Degree

Affiliation:

Hermanos Ameijeiras Hospital

Postal address:

San Lazaro and Belascoain. Centro Habana

City:

Habana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78761000 ext. 1926

Email address:

soriano@infomed.sld.cu [1]

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:

Villa Clara, Celestino Hernandez Robau hospital, Ana de la Torre, MD. Oncologyst, Second degree

Ciego de Avila, Antonio Luaces hospital, Grisel Guevara, MD. Oncologyst, Second degree

Research ethics committees:

Hermanos Ameijeiras hospital , 01/07/2013

Celestino Hernandez Robau hospital, 20/09/2013

Antonio Luaces hospital, 09/09/2013

Recruitment status

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

Recruitment status:

Recruiting

Date of first enrollment:

07/05/2014

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:

Metastatic Triple Negative Breast Cancer

Intervention(s):

Group 1 (Experimental arm): Chemotherapy (CT) + CT a dose metronomic + Nimotuzumab: 200 mg intravenously in 250 ml of isotonic saline for 30 minutes. The first dose will administer on the first day of the QT for six weeks in the induction stage and every 14 days in the maintenance phase. Group 2 (control): Chemotherapy (CT) + CT a dose metronomic. Chemotherapy (CT): 60 mg/m2 cisplatin for 6 cycles every 3 weeks, dose metronomic cyclophosphamide 50 mg per day , orally, in continuous operation while is tolerated by the patient.

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):

Stage I (Clinical Trial Phase II) Progression-free survival: Time from inclusion to the progression of neoplastic disease as defined by RECIST, version 1:1). Measuring time: 12 months Stage II (Clinical Trial Phase III) Global Survival (Time since inclusion to death). Measuring time: 24 months

Key secondary outcomes:

Neoplastic disease control (complete response + partial response + stable disease by RECIST, version 1:1). Measuring time: 12 and 24 months. Overall survival (Time from inclusion to the progression of neoplastic disease as defined by RECIST, version 1:1). Measuring time: 3, 6, 9 and 12 months. Quality of life (EORTC QLQ-C30 y QLQ-BR23). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months. Laboratory Hematologic parameters (Hemoglobin, Differential leukogram, Hematocrit, Platelets, Absolute neutrophil count). Measuring time: at baseline, every 21 days during the CT and every 2 months after the CT. Laboratory hemochemical parameters (Transaminase, glycemia, bilirubin, alkaline phosphatase, creatinine, tumor marker CA 15-3). Measuring time: at baseline, every 21 days during the CT and every 2 months after the CT. Adverse Event Occurrence of a patient (Yes, No). Measuring time: in every product administration until 24 months Intensity of AE (Common Toxicity Criteria-(CTC) version 4.0 of the National Cancer Institute of the USA). Measuring time: in every product administration until 24 months Duration of the AE (Time between the beginning and the end date of the AE). Measuring time: in every product administration until 24 months Severity EA (Grave/seriously, not grave). Measuring time: in every product administration until 24 months Attitude to study treatment (No change, dose modification, temporal interruption, definitive treatment interruption). Measuring time: in every product administration until 24 months Result of the AE (Recovered, Improved, Remains, Sequelae). Measuring time: in every product administration until 24 months Causality relationship (Very likely/safe, Probable, Possible, Unlikely, Not related, Not evaluable/not classifiable). Measuring time: in every product administration until 24 months

Selection criterias

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

Gender:

Female

Minimum age:

18 years

Maximum age:

None

Inclusion criteria:

1.Patients who met the diagnostic criteria 2.Patients express written voluntary participation in the study by signing the informed consent. 3.Patients aged ≥ 18 years. 4 Performance status 0-1 (ECOG) 5. measurable metastatic disease or advanced local recurrence. 6. Life expectancy greater than 3 months. 7.Laboratory parameters within normal limits defined as: Hematopoietic: Hemoglobin ≥ 9 g / L, Total WBC ≥ 4 x 109 cells / L, absolute neutrophil count ≥ 1500/mm ³ Platelet count ≥ 100 x 109 / L Liver : Operation liver within normal limits without liver disease demonstrated transaminases ≤ 2 x ULN and total bilirubin ≤ 2 x ULN, LDH ≤ 1.3 x above the normal limit (ULN). Renal function: creatinine ≤ 132 mmol / L.

Exclusion criteria:

1. Patients who are pregnant, breastfeeding or childbirth in the 30 days prior to inclusion. 2. Metastatic disease of the central nervous system active. 3. Active or uncontrolled infections and diseases or medical conditions that prevent the patient is treated as indicated in the protocol. 4.Patients with reproductive potential not using contraception. 5. Inability to give informed consent to participate in research . 6. Patients treated with anti-EGFR therapies in the 8 weeks prior to inclusion. 7. Patients who at the time of inclusion are participating in another clinical trial. 8. Patients suffering from illnesses associated chronic phase of decompensation (eg heart disease, diabetes, hypertension). 9. Patients presenting a history of hypersensitivity or allergy to Nimotuzumab or other similar biological product.

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:

Randomized controlled trial

Masking:

Open

Control group:

Active

Study design:

Parallel

Phase:

2-3

Target sample size:

222

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

Specialty:

BsC. Biochemestry. PhD in Health

Affiliation:

Center of Molecular Immunology

Postal Address:

216 and 15 . Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+537-2143146

Email :

mayra@cim.sld.cu [2]

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

Specialty:

BsC. Biochemestry. PhD in Health

Affiliation:

Center of Molecular Immunology

Postal Address:

216 and 15, Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+537-2143146

Email :

mayra@cim.sld.cu [2]

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:

RPCEC00000178

Date of Registration in Primary Registry:

23/05/2014

Record Verification Date:

2014/03/04

Next update date:

2015/03/04

Link to the spanish version:

Click here [3]