Pre- and post-menopausal women or men with advanced (loco regionally recurrent not amenable to curative therapy or metastatic)HER2-positive breast cancer who have progressed to trastuzumab based chemotherapy and AntiHER2-ADC
Conditions
Brief summary
Overall Response rate (ORR) defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.(see Appendix B).
Detailed description
Overall Response rate (ORR) defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. (see Appendix B, Clinical Benefit Rate at 24 weeks (CBR6) as defined by RECIST 1.1 (including patients with Complete response (CR), Partial response (PR),Stable Disease (SD) > 24 week) • Overall survival • Progression free survival • Duration of response • Time to response, ORR according to RECIST to RECIST 1.1 • Clinical Benefit Rate at 24 weeks (CBR6) as defined by RECIST 1.1 • Progression free survival • Overall survival, AEs according to CTCAE v 5.0.
Interventions
DRUGTecentriq 1 200 mg concentrate for solution for infusion
Sponsors
Solti Group
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response rate (ORR) defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.(see Appendix B). | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response rate (ORR) defined as the proportion of patients with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria. (see Appendix B, Clinical Benefit Rate at 24 weeks (CBR6) as defined by RECIST 1.1 (including patients with Complete response (CR), Partial response (PR),Stable Disease (SD) > 24 week) • Overall survival • Progression free survival • Duration of response • Time to response, ORR according to RECIST to RECIST 1.1 • Clinical Benefit Rate at 24 weeks (CBR6) as defined by RECIST 1.1 • Progression free survival • Overall survival, AEs according to CTCAE v 5.0. | — |
Countries
Spain
Outcome results
None listed