E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with invasive breast cancer in early stages. |
Pacientes con cáncer de mama infiltrante en estadios precoces. |
|
E.1.1.1 | Medical condition in easily understood language |
Patients with invasive breast cancer in early stages. |
Pacientes con cáncer de mama infiltrante en estadios precoces. |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10006187 |
E.1.2 | Term | Breast cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To describe the long-term evolution of the patients with invasive breast cancer in early stages included in GEICAM neoadjuvant and adjuvant clinical trials. Will be studied the frequency, type and location of the first relapse. |
Describir la evolución a largo plazo de los pacientes con cáncer de mama infiltrante en estadios precoces incluidos en ensayos clínicos de neoadyuvancia y adyuvancia del grupo GEICAM, estudiando la frecuencia, tipo y localización de la primera recaída. |
|
E.2.2 | Secondary objectives of the trial |
- Overall survival. - Disease free survival (in adjuvant patients). - Event-free survival (in neoadjuvant patients). - Cause of death. |
- Supervivencia global. - Supervivencia libre de enfermedad (en pacientes de estudios adyuvantes). - Supervivencia libre de evento (en pacientes de estudios neoadyuvantes). - Causa de muerte. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients included in neoadjuvant and adjuvant clinical trials with GEICAM's participation. If any of these patients had taken part or is participating in another clinical trial, she/he is eligible for this trial and her/his information will also be collected. 2. Patients whose death or contact loss has not been previously collected in the databases of the original studies. |
1. Pacientes incluidos en ensayos clínicos de neoadyuvancia o adyuvacia de estudios con participación de GEICAM. Si alguno de estos pacientes hubiera participado o se encontrara participando en otro ensayo clínico, es elegible para este ensayo y su información será también recogida. 2. Pacientes cuya muerte o pérdida de contacto no haya sido recogida previamente en las bases de datos de los estudios de procedencia. |
|
E.4 | Principal exclusion criteria |
Patients who were not included in the analyses of the original studies due to non-compliance of the eligibility criteria or the original study informed consent withdrawal. |
Pacientes que no fueron incluidos en los análisis de los estudios de procedencia por incumplimiento de los criterios de elegibilidad o por retirada del Consentimiento Informado del estudio de procedencia. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Dates of disease relapse (local, regional or distant) and second primary tumors. Event Free Survival (EvFS) in neoadjuvant studies. Event Free Survival (EFS) in adjuvant studies. |
Fechas de la recaída de la enfermedad (local, regional o a distancia) , los segundos tumores primarios y sus fechas de aparición, y la fecha de la muerte y si esta muerte está relacionada o no con el cáncer de mama. La Supervivencia Libre de Evento (SLEv) en estudios neoadyuvantes, y la Supervivencia Libre de Enfermedad (SLE) en estudios adyuvantes. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Throughout the whole follow up. Up to 30 years from the begining of the study approximately. |
A lo largo de todo el seguimiento. Aproximadamente hasta 30 años desde el inicio del estudio. |
|
E.5.2 | Secondary end point(s) |
Death date and whether or not it is related to breast cancer. Overall Survival (OS). |
Fecha de la muerte relacionada o no con el cáncer de mama. Supervivencia Global (SG). |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Non applicable |
No aplicable |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 100 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Approximately 30 years after the begining of the study. |
Aproximadamente a los 30 años del inicio del estudio. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 30 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |