None listed
Conditions
Interventions
Atezolizumab 840mg/14mL, concentrate for solution for IV, Q2W (+/-14 days)
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Inclusion criteria
Inclusion criteria: -Signed Informed Consent Form (ICF) -Ability to comply with protocol, in the investigator’s judgment -Women or men aged  18 years at time of signing ICF -Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 -Non-metastatic operable Stage IIIII breast cancer -Histologically documented TNBC (negative HER2, ER, and PgR status) -Confirmed tumor PD-L1 evaluation as documented through central testing of a representative tumor tissue specimen -Adequately excised: Patients must have undergone either breast-conserving surgery or mastectomy/nipple- or skin-sparing mastectomy. Additional information, please see the Protocol.
Exclusion criteria
Exclusion criteria: -Prior history of invasive breast cancer -Any T4 clinical tumor as defined by tumor-node metastasis classification in UICC/AJCC, 8th edition, including inflammatory breast cancer -For the currently diagnosed breast cancer, any previous systemic anti-cancer treatment (e.g., neoadjuvant or adjuvant), including, but not limited to, chemotherapy, anti-HER2 therapy (e.g., trastuzumab, trastuzumab emtansine, pertuzumab, lapatinib, neratinib, or other tyrosine kinase inhibitors), hormonal therapy, or anti-cancer RT other than planned in the context of this study and described in Appendix 8. -Previous therapy with anthracyclines or taxanes for any malignancy -History of DCIS and/or LCIS that was treated with any form of systemic, hormonal therapy, or RT to the ipsilateral breast where invasive cancer subsequently developed -Contraindication to RT when adjuvant RT is clinically indicated -Cardiopulmonary dysfunction as defined by any of the following prior to randomization. Additional information, please see the Protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:iDFS, defined as the time from randomization until the date of the first occurrence of one of the following events: - Ipsilateral invasive breast tumor recurrence (i.e., an invasive breast cancer involving the same breast parenchyma as the original primary lesion) - Ipsilateral local-regional invasive breast cancer recurrence (i.e., an invasive breast cancer in the axilla, regional lymph nodes, chest wall, and/or skin of the ipsilateral breast) - Ipsilateral second primary invasive breast cancer - Contralateral invasive breast cancer - Distant recurrence (i.e., evidence of breast cancer in any anatomic site [other than the sites mentioned above]) that has either been histologically confirmed and/or clinically/radiographically diagnosed as recurrent invasive breast cancer - Death attributable to any cause, including breast cancer, or unknown cause Measure:To evaluate the efficacy of adjuvant atezolizumab + T-AC/EC compared with T-AC/EC alone in patients with TNBC Timepoints:From randomization until the date of the first occurrence of an event of invasive disease | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:• iDFS in the subpopulation with PD-L1-selected tumor status (IC1/2/3) • iDFS in the subpopulation with node-positive disease • OS, defined as the time from randomization to death from any cause. • iDFS defined the same way as the primary endpoint but including second primary non-breast invasive cancer (except for non-melanoma skin cancers and in situ carcinoma of any site) as an event. • RFI, defined as the time from randomization until local, regional, or distant disease recurrence. • Distant RFI, defined as the time from randomization until distant disease recurrence only. • DFS, defined as any event of the primary endpoint and new diagnosis of an ipsilateral or contralateral non-invasive breast cancer. Measure:To evaluate the efficacy of adjuvant atezolizumab + T- AC/EC compared with T-AC/EC alone. Timepoints:From randomization until the date of the first occurrence of an event of invasive disease. ; Outcome name:Mean and mean changes from baseline score in function (role, physical) and GHS/HRQoL by assessment timepoint, and between treatment arms as assessed by the functional and GHS/HRQoL scales of the EORTC QLQ-C30. Measure:To evaluate PROs of function and HRQoL associated with atezolizumab + T-AC/EC compared with T-AC/EC alone, as measured by the functional and HRQoL scales of the EORTC QLQ-C30. Timepoints:During Induction (Weeks 1-20): Day 1 of each cycle Arm A Maintenance (weeks 21-53) Day 1 of each cycle ± 3 days) Arm B Monitoring (weeks 21-53) Day 1 of each cycle ±7 days) | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, China, Czech Republic, Denmark, France, Germany, Hungary, Ireland, Israel, Italy, Japan, Korea South, Mexico, Peru, Poland, Romania, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Thailand, Ukraine, United Kindgdom, United States
Contacts
Public ContactElizabeth Rospigliosi
RPS PERU S.A.C
Outcome results
None listed