E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Breast cancer |
Cáncer de mama |
|
E.1.1.1 | Medical condition in easily understood language |
Breast cancer |
Cáncer de mama |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01] |
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 |
The main of this study is to evaluate 18F-FLT (Fluorothymidine) as an early indicator of tumor response to neoadjuvant treatment in breast cancer. |
El objetivo principal de este estudio es evaluar la 18F-FLT (Fluorotimidina) como indicador temprano de la respuesta tumoral al tratamiento neoadyuvante en cáncer de mama. |
|
E.2.2 | Secondary objectives of the trial |
1. Study the prognostic power of the new tracers such as 18F-FLT to determine the early response to neoadjuvant treatment 2. Study the correlation between the spatial heterogeneity observed and the response to treatment, as well as the biological characteristics of the tumour 3. Implement software tools which allow information about spatial heterogeneity to be combined with conventional PET parameters based on Standard Uptake Value (SUV) o estimate the probability of treatment response |
1. Estudiar el poder pronóstico de nuevos trazadores como la 18F-FLT para determinar de forma temprana la respuesta al tratamiento neoadyuvante 2. Estudiar la correlación entre la heterogeneidad espacial observada y la respuesta al tratamiento, así como a las características biológicas del tumor 3. Implementar herramientas software que permitan combinar la información sobre la heterogeneidad espacial con parámetros convencionales de PET basados en Standard Uptake Value (SUV) para estimar la probabilidad de respuesta al tratamiento |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Adult women with breast cancer whose therapeutic plan is neoadjuvant chemotherapy - Negative pregnancy test - Information Sheet and Informed Consent Form signed by the patient |
- Mujeres mayores de edad con cáncer de mama cuyo plan terapéutico sea la quimioterapia neoadyuvante - Test de embarazo negativo - Hoja de Información y Documento de Consentimiento firmadas por la paciente |
|
E.4 | Principal exclusion criteria |
- Healthy women - Women with breast cancer under 18 - Diabetic women with breast cancer - Pregnant women with breast cancer - Breast feeding women with breast cancer - Women with breast cancer who have undergone a surgical procedure - Women with breast cancer who have received chemotherapy or radiotherapy before the beginning of the study |
- Mujeres sanas - Mujeres menores de 18 años con cáncer de mama - Mujeres diabéticas con cáncer de mama - Mujeres embarazadas con cáncer de mama - Mujeres con cáncer de mama que se encuentren en período de lactancia - Mujeres con cáncer de mama que hayan sido intervenidas quirúrgicamente - Mujeres con cáncer de mama que hayan recibido quimioterapia o radioterapia antes del inicio del estudio |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Quantification of SUVmean and SUVmax variables from PET studies performed in each patient |
Obtención de las variables SUVmean y SUVmax de los estudios PET realizados en cada paciente |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Once all PET/CT images have been acquired, in other words, from the last visit of the last patient |
Una vez se hayan adquirido todas las imágenes PET/CT, es decir, a partir de la última visita de la última paciente |
|
E.5.2 | Secondary end point(s) |
Quantification of the total volume of the tumoral lesion in the corresponding CT images and correlation between image variables and pathology data |
Obtención del volumen total de la lesión tumoral en las imágenes CT correspondientes y de la correlación entre las variables obtenidas por imagen y los resultados de anatomía patológica |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
Once all patients have finished the chemotherapy and histological data is available |
Una vez las pacientes hayan terminado su ciclo de quimioterapia y se disponga de información histológica de los tumores |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
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
|
LVLS |
Última visita de la última paciente |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 18 |
E.8.9.1 | In the Member State concerned days | |