E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
BREAST CANCER |
TUMORE DELLA MAMMELLA |
|
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 |
To compare continuous letrozole for five years with intermittent letrozole over a five year period for postmenopausal women who are disease-free following 4-6 years of prior adjuvant endocrine therapy with SERM(s) and/or AI(s) for endocrine-responsive, node-positive, operable breast cancer. |
Confrontare la somministrazione continua di letrozolo con la somministrazione intermittente su un periodo di cinque anni in donne in postmenopausa, prive di recidiva. |
|
E.2.2 | Secondary objectives of the trial |
overall survival (OS), distant disease-free survival (DDFS), breast cancer free interval (BCFI), sites of first failure, second (non-breast) malignancies, deaths without prior cancer events, and adverse events. |
Confrontare la sopravvivenza generale (OS),sopravvivenza senza manifestazione di metastasi a distanza (DDFS),intervallo di tempo in assenza di tumore al seno (BCFI),siti della prima insorgenza,tumori maligni secondari (non mammari),morte senza precedenti eventi oncologici,ed eventi avversi,tra donne trattate con letrozolo somministrato in modo continuo rispetto a donne trattate con letrozolo somministrato in modo intermittente. |
|
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
ALTRI SOTTOSTUDI: Obiettivo primario del sottostudio SOLE-EST e` quello di valutare i livelli sierici di Estradiolo, Estrone, Estrone solfato e della Sex Hormone Binding Globulin durante il trattamento con letrozolo.
|
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E.3 | Principal inclusion criteria |
Postmenopausal patients with oparable breast cancer. Disease free patients at the time of randomization - Diagnosis of hormone receptor positive breast cancer (ER and/or PgR > 10%), node positive - Patients who completed a 4-6 year adjuvant treatment with SERMs and or aromatase inhibitors- Written informed consent |
Pazienti in postmenopausa con diagnosi di carcinoma mammario operabile -Pazienti libere da malattia alla randomizzazione -Diagnosi di carcinoma mammario invasivo endocrinoresponsivo (ER e/o PgR > 10%) con coinvolgimento linfonodale ascellare o della catena mammaria interna -Le pazienti devono aver completato 4-6 anni di un trattamento adiuvante endocrino con SERMs e/o inibitori dell'aromatasi. -Consenso informato scritto -Accessibilita' geografica |
|
E.4 | Principal exclusion criteria |
-Pre menopausal patients - Breast inflammatory cancer - Sovraclavear node involvement- Bilateral breast cancer- Bone fracture due to osteoporosis during the 4-6 years hormonal treatment - Patients with previous diagnosis of controlateral or ipsilateral breast cancer |
-Pazienti in premenopausa -Pazienti con carcinoma mammario infiammatorio alla diagnosi -Pazienti con coinvolgimento linfonodale sovraclaveare -Pazienti con carcinoma mammario bilaterale alla diagnosi -Pazienti che hanno avuto una precedente frattura ossea per osteoporosi, durante i precedenti 4-6 anni di trattamento ormonale - Pazienti con anamnesi positiva per carcinoma mammario infiltrante ipsilaterale o controlaterale . |
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E.5 End points |
E.5.1 | Primary end point(s) |
disease free survival |
sopravvivenza libera da malattia |
|
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) | 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 | Yes |
E.8.1.1 | Randomised | Yes |
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 | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
stesso farmaco intermittente |
|
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 | 26 |
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 | 13 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 13 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |