A PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND STUDY OF RO7247669 COMBINED WITH NAB-PACLITAXEL COMPARED WITH PEMBROLIZUMAB COMBINED WITH NAB-PACLITAXEL IN PARTICIPANTS WITH PREVIOUSLY UNTREATED, PD-L1*POSITIVE, LOCALLY-ADVANCED UNRESECTABLE OR METASTATIC TRIPLE-NEGATIVE BREAST CANCER

Phase 2

• Conditions: TNBC; Breast cancer; 10006291

• Registration Number: NL-OMON53202
• Lead Sponsor: Roche Nederland B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 2

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

• 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) < 30 mL/min/1.73 m2 as calculated through
use of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation
• History of malignancy within 5 years prior to consent, except for the cancer
under investigation in this study and malignancies with a negligible risk of
metastasis or death (e.g., 5-year OS rate > 90%)
• Symptomatic, untreated, or actively progressing central nervous system (CNS)
metastases

More exclusion criteria are stated in the protocol section 5.2

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>PFS, defined as the time from randomization to the first occurrence of disease<br /><br>progression, as determined by the investigator according to RECIST v1.1, or<br /><br>death from any cause (whichever occurs first). </p><br>