NGcGM3/VSSP in patients with metastatic hormone-receptor positive and HER2 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:

Specific active immunotherapy with the vaccine NGcGM3/VSSP in patients with metastatic hormone-receptor positive and HER2 negative breast cancer

Secondary indentifying numbers:

Not applicable

Issuing authority of the secondary identifying numbers:

Not applicable

Source(s) of monetary or material support:

Center of Molecular Immunology (CIM) Ministry of Public Health (MINSAP)

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)

Reference number:

In process

Principal investigator

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

First name:

Braulio

Last name:

Mestre Fernández

Medical Specialty :

First grade specialist in Oncology

Affiliation:

National Institute of Oncology and Radiobiology (INOR)

Postal address:

29 and F, Vedado

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+53-78388587

Email address:

brauliofdez@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:

La Habana, National Institute of Oncology and Radiobiology, Idania Sanchez, MD. I Grade specialist in Oncology

Villa Clara, Celestino Hernandez Hospital, Ana de la Torre, MD. I Grade specialist in Oncology

Santiago de Cuba, Conrado Benitez Hospital , Miguel Ofarril, MD. I Grade specialist in Oncology

Pinar del Rio, III Congreso Hospital, Yamilka Sanchez, MD. I Grade specialist in Oncology

Sancti Spiritus, Camilo Cienfuegos Hospital, Yania Luisa Jimenez Madrigal, MD. I Grade specialist in Oncology

Holguin, Vladimir I. Lenin Hospital, Diosdado Cruz del Pino, MD. I Grade specialist in Oncology

Cienfuegos, Gustavo Aldereguia Hospital, Omayda Fraga Suarez, MD. I Grade specialist in Oncology

Ciego de Avila, Antonio Luaces Hospital, Gissel Guevara Artiles, MD. I Grade specialist in Oncology

Camaguey, Maria Curie Hospital, Monica Limia Pacheco , MD. I Grade specialist in Oncology

Las Tunas, Ernesto Guevara Hospital, Ramon Leon Fonseca, MD. I Grade specialist in Oncology

Matanzas, J.R. Lopez Tabranes Hospital, Edadny Medina, MD. I Grade specialist in Oncology

Research ethics committees:

National Institute of Oncology and Radiobiology, 17/06/16

Hospital Celestino Hernández, 10/06/16

Hospital Conrado Benitez, 13/07/16

Hospital III Congreso, 15/06/16

Hospital Camilo Cienfuegos, 16/06/16

Hospital Vladimir I. Lenin, 07/07/16

Hospital Gustavo Aldereguia, 27/07/16

Hospital Antonio Luaces, 06/07/16

Hospital Maria Curie,28/06/16

Hospital Ernesto Guevara, 06/07/16

Hospital J.R. López Tabranes, 13/06/16

Recruitment status

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

Recruitment status:

Pending

Date of first enrollment:

01/02/2017

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 hormone-receptor positive and HER2 negative breast cancer

Health condition(s) code:

Breast Neoplasms

Breast Diseases

Intervention(s):

Group 1 (Experimental): Onco-specific treatment + NGcGm3/VSSP (900μg) subcutaneously as follows: the first 5 immunizations every 14 days, and the following immunizations every 28 days, up to 20 months Group 2 (Control): Onco-specific treatment + placebo subcutaneously as follows: the first 5 immunizations every 14 days, and the following immunizations every 28 days, up to 20 months

Intervention code:

G(M3) Ganglioside

Adjuvants, Immunologic

Proteolipids

Antineoplastic Agents

Gangliosides

Placebo

Injections, Subcutaneous

Intervention keyword:

NGcGM3/VSSP

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):

Progression-free survival (Time from randomization until progression of metastatic disease, or death from any cause). Measuring time: 20 months.

Key secondary outcomes:

Overall Survival (Time from randomization until death, from any cause). Measuring time: 20 months. Antitumor response (RECIST (version 1.1) scale). Measuring time: After completed the third cycle and the sixth cycle of first-line chemotherapy for metastatic disease, and then every 4 months up to 20 months. Immune response variables: IgM and IgG against NGcGM3 ganglioside (ELISA). Measuring time: At baseline, Third (85), Sixth (169), Twelfth (337) days Recognition and lytic capacity of IgM and IgG antibodies induced by vaccination and directed to NGcGM3 on tumor lines expressing ganglioside (flow cytometry). Measuring time: At baseline, Third (85), Sixth (169), Twelfth (337) days Safety variables: Adverse Events (AE). Measuring time: Time of evaluation: every 3 months until 20 months. The AE are defined by - Description of the AE (Name of the AE) - Intensity of the AE (mild, moderate, severe, life-threatening, death) - Causality relationship (very probable, probable, possible, unlikely, not related, not evaluable ) - Gravity (serious, non serious) - Previous knowledge (expected, non expected) - Result (recovered, improved, sequelae, death ) - Treatment (none, medication, surgical procedure, transfusion, other) Quality of life (Questionnaires EORTC QLQ-C30 (cancer), EORTC QLQ-BR23 (breast cancer), and EORTC QLQ-BM22 (patients with bone metastases) . Measuring time: At baseline, and at 6, 9, 15 and 20 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. Female patients with hormone-receptor positive and HER2-negative metastatic breast cancer, not previously treated for the metastatic disease. 2. Patients older than 18 years. 3. Patients who consent to participate in the study by signing the informed consent model. 4. Patients with ECOG scale of Performance Status ≤ 2. 5. Patients who are not pregnant or breastfeeding. 6. Patients with paraffin-embedded samples for evaluation of the expression of NGcGM3. 7. Patients with normal functioning of organs and bone marrow defined by laboratory parameters.

Exclusion criteria:

1. Patients who have been treated with NGcGm3/VSSP within 6 months prior to inclusion. 2. Patients who have been included in another clinical trial within 6 months prior to inclusion. 3. Patients with inflammatory carcinoma of the breast. 4. Patients with brain metastases. 5. Patients with acute or chronic infectious diseases. 6. Patients with decompensated chronic diseases.

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:

Double Blind

Control group:

Placebo

Study design:

Parallel

Phase:

2-3

Target sample size:

286

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:

Aliz

Last Name:

Vega Rodríguez

Specialty:

I Grade Specialist in Immunology

Affiliation:

Center of Molecular Immunology

Postal Address:

216 & 15. Atabey, Playa

City:

Havana

País:

Cuba

Zip Code:

11600

Telephone:

+53772717933, ext 3489

Email :

aliz@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:

Braulio

Last Name:

Mestre Fernandez

Specialty:

I Grade specialist in Oncology

Affiliation:

National Institute of Oncology and Radiobiology

Postal Address:

29 & F. Vedado

City:

Havana

País:

Cuba

Zip Code:

10400

Telephone:

+5378388587

Email :

brauliofdez@infomed.sld.cu [1]

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:

RPCEC00000220

Date of Registration in Primary Registry:

28/11/2016

Record Verification Date:

2016/12/22

Next update date:

2017/12/22

Link to the spanish version:

Click here [3]