HER2-negative, stage II–IIIB, neoadjuvant chemotherapy, estrogen receptor–positive, breast carcinoma
Conditions
Brief summary
the proportion of enrolled patients treated with NET plus abemaciclib without receiving neoadjuvant or adjuvant chemotherapy. Patients receiving chemotherapy at any time after study enrollment, or refusing the MDT-recommended NET plus abemaciclib strategy, will be considered failures, the proportion of patients achieving surgical de-escalation after neoadjuvant therapy, defined as conversion from mastectomy to breast-conserving surgery and/or from axillary lymph node dissection to sentinel lymph node biopsy, according to comparison between baseline MDT surgical recommendation and definitive surgery performed.
Detailed description
Secondary Endpoints will be evaluated in the overall population and according to the neoadjuvant treatment received (NET+abemaciclib and NCT group) and include: ● the ORR, Secondary Endpoints will be evaluated in the overall population and according to the neoadjuvant treatment received (NET+abemaciclib and NCT group) and include: ●the rate of pathological complete response (pCR), Secondary Endpoints will be evaluated in the overall population and according to the neoadjuvant treatment received (NET+abemaciclib and NCT group) and include: ●the rate of discordancy between the technical suitability of BCS and the actual performance of mastectomy, and the reasons for the discordancy., Secondary Endpoints will be evaluated in the overall population and according to the neoadjuvant treatment received (NET+abemaciclib and NCT group) and include: ● the QoL change from baseline during neoadjuvant therapy measured by EORTC QLQ-C30, EORTC QLQ-BR42 and EORTC QLQ-FA12 questionnaires, Secondary Endpoints will be evaluated in the overall population and according to the neoadjuvant treatment received (NET+abemaciclib and NCT group) and include: ●the 6- and 12-month event (locoregional and distant progression)-free survival rates, Secondary Endpoints will be evaluated in the overall population and according to the neoadjuvant treatment received (NET+abemaciclib and NCT group) and include: ●Adverse Events as per CTCAE v.6.0
Interventions
DRUGExemestano Sandoz 25 mg comprimidos recubiertos con pelicula EFG
DRUGABEMACICLIB
DRUGEpirubicina Accord 2 mg/ml solución inyectable o para perfusión EFG
DRUGANASTROZOLO DOC Generici 1 mg compresse rivestite con film
DRUGLetrozolo Teva 2
DRUG5 mg compresse rivestite con film
DRUGCiclofosfamide Accord 200 mg/mL concentrato per soluzione iniettabile/per infusione
Sponsors
Istituto Di Ricerche Farmacologiche Mario Negri
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of enrolled patients treated with NET plus abemaciclib without receiving neoadjuvant or adjuvant chemotherapy. Patients receiving chemotherapy at any time after study enrollment, or refusing the MDT-recommended NET plus abemaciclib strategy, will be considered failures, the proportion of patients achieving surgical de-escalation after neoadjuvant therapy, defined as conversion from mastectomy to breast-conserving surgery and/or from axillary lymph node dissection to sentinel lymph node biopsy, according to comparison between baseline MDT surgical recommendation and definitive surgery performed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints will be evaluated in the overall population and according to the neoadjuvant treatment received (NET+abemaciclib and NCT group) and include: ● the ORR, Secondary Endpoints will be evaluated in the overall population and according to the neoadjuvant treatment received (NET+abemaciclib and NCT group) and include: ●the rate of pathological complete response (pCR), Secondary Endpoints will be evaluated in the overall population and according to the neoadjuvant treatment received (NET+abemaciclib and NCT group) and include: ●the rate of discordancy between the technical suitability of BCS and the actual performance of mastectomy, and the reasons for the discordancy., Secondary Endpoints will be evaluated in the overall population and according to the neoadjuvant treatment received (NET+abemaciclib and NCT group) and include: ● the QoL change from baseline during neoadjuvant therapy measured by EORTC QLQ-C30, EORTC QLQ-BR42 and EORTC QLQ-FA12 questionnaires, Secondary En | — |
Outcome results
None listed