E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
LOCALLY ADVANCED BREAST CANCER |
CANCRO DELLA MAMMELLA LOCALMENTE AVANZATO |
|
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 | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10057654 |
E.1.2 | Term | Breast cancer female |
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 |
We will investigate the antitumor efficacy of Letrozole in patients diagnosed with endocrine responsive (ER and PgR ≥ 10%) locally advanced breast tumors. The primary objective of the study is to estimate the effect of a prolonged preoperative treatment in terms of clinical response (complete and partial) |
L'obiettivo principale dello studio e' valutare la attivita' in termini di risposte cliniche obiettive, sia complete che parziali, di un trattamento preoperatorio con letrozolo (± triptorelin) per 6-9 mesi in donne con carcinoma mammario localmente avanzato ER e PgR > 10%. |
|
E.2.2 | Secondary objectives of the trial |
The rate of pathological complete remission
2. The disease free survival (DFS) and overall survival (OS)
3. The extent of ovarian function suppression in premenopausal women upon letrozole by serial measurements of circulating gonadotropins, estradiol and estrone. |
la percentuale di risposte patologiche complete (pCR);
intervallo libero da malattia DFS) e sopravvivenza globale (OS);
la valutazione della soppressione ovarica in corso di letrozolo nella donne in premenopausa. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with histologically proven, locally advanced, primary breast cancer (cT2-T4b, N0-2, M0) Endocrine responsive primary breast cancer (ER and PgR #8805; 50%) Absence of HER2/neu overexpression or amplification Absence of distant metastasis |
carcinoma mammario istologicamente dimostrato cT2-cT4b N0 M0 carcinoma mammario endocrinoresponsivo (ER e PgR #8805; 50%) PS=0-2 Tumore misurabile o valutabile Funzionalita' renale, epatica e midollare adeguata Assenza di patologie concomitanti gravi (diabete, patologie cardiovascolari, renale e neurologiche non compensate clinicamente) Asenza di patologie psichiatriche che possano compromettere una partecipazione consapevole. Test di gravidanza negativo |
|
E.4 | Principal exclusion criteria |
Presence of HER2/neu overexpression or amplification
Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator.
Patients with distant metastatic disease
Previous adjuvant and/or neoadjuvant treatment for breast cancer
Other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ. |
Sovraespressione di HER2
Malattia a distanza
Patologie concomitanti non in controllo clinico
Precedenti trattamenti sistemici (neoadiuvanti e adiuvanti) per il carcinoma mammario
Precedenti neoplasie invasive eccetto che tumori cutanei non melanomi escissi radicalmente. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
rate of objective response (CR and PR) after 6 and 9 months of letrozole. |
risposte cliniche obiettive, sia complete che parziali, di un trattamento preoperatorio con letrozolo (± triptorelin) per 6-9 mesi |
|
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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | Information not present in EudraCT |
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | 0 |