Triple Negative Breast Cancer
Conditions
Brief summary
IDFS (Invasive Disease Free Survival), defined by STEEP, as time from randomization to the date of first invasive disease recurrence (local, regional or distant), date of second primary invasive cancer (breast or not), or date of death from any cause, whichever occurs first.
Detailed description
1. OS status., 2. Change from baseline in health-related quality of life (HRQOL) using the global health status/QoL scale from EORTC QLQ-C30 and EQ-5D-5L questionnaires., 3. Breast cancer-free interval (BCFI)., 4. Distant disease-free survival (DDFS)., 5. Incidence of AEs and SAEs, incidence of abnormal laboratory values, and change from baseline in safety parameters.
Interventions
DRUGPEMBROLIZUMAB
DRUGAdagloxad simolenin with adjuvant
DRUGCAPECITABINE
Sponsors
Obi Pharma Inc.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IDFS (Invasive Disease Free Survival), defined by STEEP, as time from randomization to the date of first invasive disease recurrence (local, regional or distant), date of second primary invasive cancer (breast or not), or date of death from any cause, whichever occurs first. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. OS status., 2. Change from baseline in health-related quality of life (HRQOL) using the global health status/QoL scale from EORTC QLQ-C30 and EQ-5D-5L questionnaires., 3. Breast cancer-free interval (BCFI)., 4. Distant disease-free survival (DDFS)., 5. Incidence of AEs and SAEs, incidence of abnormal laboratory values, and change from baseline in safety parameters. | — |
Countries
Poland
Outcome results
None listed