E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Postmenopausal Women with Hormone Receptor Postive, HER2 Negative Breast Cancer |
Donne in postmenopausa con carcinoma mammario positivo per i recettori ormonali, HER2 negativo |
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E.1.1.1 | Medical condition in easily understood language |
Breast Cancer |
Carcinoma mammario |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nutritional and Metabolic Diseases [C18] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007050 |
E.1.2 | Term | Cancer |
E.1.2 | System Organ Class | 100000004864 |
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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 the biological activity of abemaciclib in combination with anastrozole, abemaciclib monotherapy, and anastrozole monotherapy by assessing the percentage change from the baseline value in Ki67 expression after 2 weeks of therapy. |
L¿obiettivo primario dello studio I3Y-MC-JPBY (JPBY) ¿ mettere a confronto l¿attivit¿ biologica di abemaciclib in associazione ad anastrozolo, abemaciclib in monoterapia e anastrozolo in monoterapia valutando la variazione percentuale rispetto al valore basale dell¿espressione di Ki67 dopo 2 settimane di terapia. |
|
E.2.2 | Secondary objectives of the trial |
pathologic complete response (pCR) defined as absence of invasive cancer in the breast and sampled regional lymph nodes ¿ clinical objective response (RECIST criteria 1.1) ¿ radiologic response (RECIST criteria 1.1) ¿ safety and tolerability ¿ symptom burden via the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) instrument ¿ pharmacokinetics (PK) of abemaciclib and anastrozole |
¿ la risposta patologica completa (pCR) definita come assenza di carcinoma invasivo nella mammella e nei linfonodi regionali campione ¿ la risposta clinica obiettiva (criteri RECIST [Response Evaluation Criteria in Solid Tumors], versione 1.1) ¿ la risposta radiologica (criteri RECIST versione 1.1) ¿ la sicurezza e la tollerabilit¿ ¿ l¿impatto della tossicit¿, tramite il questionario EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-C30) ¿ la farmacocinetica (PK) di abemaciclib e anastrozolo
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
are female and =18 years of age • have postmenopausal status • adenocarcinoma of the breast • breast tumor =1 cm in diameter • breast cancer that is HR+, HER2- • neoadjuvant endocrine monotherapy is deemed to be a suitable therapy • primary breast cancer that is suitable for baseline core biopsy • have adequate organ function |
- • sesso femminile ed età =18 anni • in postmenopausa • adenocarcinoma della mammella • tumore della mammella =1 cm di diametro • cancro della mammella HR+, HER2- • monoterapia endocrina neoadiuvante ritenuta una terapia idonea • carcinoma mammario primitivo ritenuto idoneo alla biopsia percutanea basale • funzionalità d’organo adeguata
|
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E.4 | Principal exclusion criteria |
• bilateral invasive breast cancer • metastatic breast cancer (local spread to axillary lymph nodes is permitted) • inflammatory breast cancer • prior systemic therapy or radiotherapy for invasive or noninvasive breast cancer in the same breast as currently being treated prior radiotherapy to the ipsilateral chest wall for any malignancy • prior anti-estrogen therapy |
• carcinoma mammario invasivo bilaterale • carcinoma mammario metastatico (ammessa la diffusione locale ai linfonodi ascellari) • carcinoma mammario infiammatorio • terapia sistemica o radioterapia pregressa per il carcinoma mammario invasivo o non invasivo nella stessa mammella da trattare • radioterapia pregressa alla parete toracica omolaterale per una qualsiasi neoplasia maligna • pregressa terapia antiestrogenica |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Percent change in Ki67 expression from baseline to the core biopsy 2 weeks after the start of treatment |
Percentuale di cambiamento nell'espressione di Ki67 dal basale alla biopsia core 2 settimane dopo l'inizio del trattamento. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline, 2 weeks |
Basale, 2 settimane |
|
E.5.2 | Secondary end point(s) |
¿ pCR defined as absence of invasive cancer in the breast and sampled regional lymph nodes ¿ clinical response of the breast tumor to therapy as assessed by caliper measurement ¿ radiologic response of the breast tumor as assessed by radiologic or ultrasound assessment ¿ adverse events ¿ EORTC QLQ-C30 ¿ PK of abemaciclib and its metabolites and anastrozole ¿ Ki67 ¿ Whole blood, plasma, and tissue samples will be tested for biomarkers relevant to abemaciclib and the disease state and to correlate these markers to clinical outcome and to abemaciclib. |
¿ pCR definita come assenza di carcinoma invasivo nella mammella e nei linfonodi regionali campione ¿ risposta clinica del tumore mammario alla terapia valutata tramite misurazione con calibro ¿ risposta radiologica del tumore mammario valutata tramite esami radiologici o ecografici ¿ eventi avversi¿ EORTC QLQ-C30 ¿ farmacocinetica di abemaciclib e suoi metaboliti e di anastrozolo ¿ Ki67 ¿ campioni di sangue intero, plasma e tessuto saranno esaminati per ricercare biomarcatori relativi ad abemaciclib e allo stato della malattia e per mettere in correlazioni tali marcatori con gli outcome clinici e con abemaciclib. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | Yes |
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 | 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 | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Canada |
Korea, Democratic People's Republic of |
Taiwan |
United States |
Austria |
Belgium |
Germany |
Italy |
Netherlands |
Spain |
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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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |