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 |
Mujeres postmenopausicas con receptores hormonales positivos, HER2 negativo en cancer de mama |
|
E.1.1.1 | Medical condition in easily understood language |
Breast Cancer |
Cancer de mama |
|
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 | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10007050 |
E.1.2 | Term | Cancer |
E.1.2 | System Organ Class | 100000004864 |
|
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. |
Comparar la actividad biológica de abemaciclib en combinación con anastrozol, de abemaciclib en monoterapia y de anastrozol en monoterapia, para lo que se evaluará el porcentaje de cambio respecto al valor basal en la expresión de Ki67, tras 2 semanas de tratamiento. |
|
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 |
Respuesta anatomopatológica completa (RCp), definida por la ausencia de cáncer infiltrante en la mama y en los ganglios linfáticos regionales evaluados. - Respuesta clínica objetiva (Criterios de evaluación de la respuesta en tumores sólidos [RECIST], 1.1). - Respuesta radiológica (criterios RECIST 1.1). - Seguridad y tolerabilidad. - Carga de toxicidad, de acuerdo con los resultados del cuestionario de calidad de vida Core 30 de la Organización Europea para la Investigación y el Tratamiento del Cáncer (EORTC QLQ-C30). -Farmacocinética (FC) de abemaciclib y anastrozol. |
|
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 |
Ser mujer de >= 18 años, posmenopusicas, con adenocarcinoma en la mama con un tamaño >= 1 cm de diametro, cancer de mama HR+, HER2-, La monoterapia hormonal neoadyuvante se considera un tratamiento adecuado, Cáncer de mama primario que permita realizar una biopsia basal con aguja gruesa, ECOG >=1 |
|
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 non-invasive breast cancer in the same breast as currently being treated ? prior radiotherapy to the ipsilateral chest wall for any malignancy ? prior anti-estrogen therapy |
Cáncer de mama bilateral infiltrante, Cáncer de mama metastásico (se permite la diseminación local a los ganglios linfáticos axilares), Cáncer de mama inflamatorio, Tratamiento sistémico o radioterapia previas para cáncer de mama infiltrante o no infiltrante en la misma mama que se trate en la actualidad, Radioterapia previa a la pared torácica ipsilateral para tratar cualquier neoplasia maligna., Tratamiento antiestrógenico previo |
|
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 |
Porcentaje de cambio respecto al valor basal en la expresión de Ki67, tras 2 semanas de tratamiento. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline, 2 weeks |
Inicio, 2 semanas |
|
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. |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | 6 |
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 | No |
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 |
Austria |
Belgium |
Canada |
Germany |
Italy |
Korea, Democratic People's Republic of |
Netherlands |
Spain |
Taiwan |
United States |
|
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
|
last patient, last visit |
Ultimo paciente, ultima visita |
|
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 | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |