TNBC Breast cancer TNBC
Conditions
Interventions
RO7247669 plus nab-paclitaxel compared with pembrolizumab plus nab-paclitaxel
Sponsors
Roche Nederland B.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Signed Informed Consent Form • Age >= 18 years at the time of signing Informed Consent Form • Metastatic or locally advanced unresectable, histologically documented TNBC (absence of HER2-over-expression, ER, and PgR expression by local assessment) • Measurable disease per RECIST v1.1 • If metastatic disease (Stage IV), measurable disease outside of the bone • Previously irradiated lesions can be considered as measurable disease only if disease progression has been unequivocally documented at that same lesion since radiation • No prior systemic therapy for metastatic or locally advanced unresectable TNBC • Tumor PD-L1 expression as documented through central testing of a representative tumor tissue specimen. • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 (see Appendix 9) More inclusion criteria are stated in protocol section 5.1
Exclusion criteria
Exclusion criteria: • Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 4 months after the final dose of RO7247669 or pembrolizumab, and 6 months after the final dose of nab-paclitaxel. • Poor venous access • Glomerular filtration rate (GFR) 90%) • Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases More exclusion criteria are stated in the protocol section 5.2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS, defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause (whichever occurs first). | — |
Secondary
| Measure | Time frame |
|---|---|
| • ORR, defined as the proportion of participants with a CR or a PR on two consecutive occasions >= 4 weeks apart, as determined by the investigator according to RECIST v1.1 • DOR, defined as the time from the first occurrence of a confirmed objective response to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first • OS, defined as the time from randomization to death from any cause • PFS rate at 12 months, defined as the proportion of participants who have not experienced disease progression or death from any cause at 12 months after randomization, as determined by the investigator, according to RECIST v1.1 • OS rate at 12 months, defined as the proportion of participants who have not experienced death from any cause at 12 months after randomization • Incidence and severity of adverse events, with severity determined according to NCI CTCAE v5.0 • Change from baseline in targeted clinical laboratory test results • Change from baseline in targeted vital signs • PK profiles and parameters derived for RO7247669 including but not limited to, when appropriate and when data allow, the parameters listed below: - Maximum concentration - Time of maximum concentration - Clearance - Volume of distribution at steady state - Area under the concentration-time curve - Half*life • Incidence and titer of RO7247669 ADA during the study relative to the prevalence of ADA at baseline and impact of ADAs on exposure, activity and safety | — |
Countries
Netherlands
Outcome results
None listed