None listed
Conditions
Interventions
- Inoperable recurrent TNBC with previously untreated local or metastatic recurrence
progression <12 months from last therapy for eBC
Inoperable recurrent TNBC with previously untreated local or metastatic recurrence
progression <12 months from last therapy for early breast cancer
PD-L1-positive only.
Arm B: 21-day Cycles until PD:
carboplatin/gemcitabine OR capecitabine* + placebo
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Have provided written informed consent 2. Male or female ≥ 18 years of age 3. In the investigator’s judgment is willing and able to comply with the study protocol including completion of patient-reported outcomes questionnaires 4. Histologically confirmed TNBC that is either locally recurrent, inoperable and cannot be treated with curative intent or is metastatic. 5. Prior treatment (of early breast cancer) with an anthracycline and taxane 6. Documented disease progression (e.g., with biopsy sample, pathology, or imaging report) occurring within 12 months (<12 months) from the last treatment with curative intent, i.e. 7. Have not received prior chemotherapy or targeted systemic therapy for their locally advanced inoperable or metastatic recurrence. 8.Measurable or non-measurable disease, as defined by RECIST 1.1 (Note: previously irradiated lesions may be considered as measurable disease only if disease progression has been unequivocally documented at that site since radiation). 9. Availability of a representative formalin-fixed paraffin-embedded (FFPE) tumour block (preferred) or at least 17 unstained slides, collected within 3 months prior to randomisation, with an associated pathology report, if available. If a tumour sample taken within 3 months before randomisation is not available and a tumour biopsy is not clinically feasible, the primary surgical resection sample or the most recent FFPE tumour biopsy sample may be used. Of these additional options, the most recent sample should be used.
Exclusion criteria
Exclusion criteria: 1. Spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated spinal cord compression without evidence that disease has been clinically stable for > 2 weeks prior to randomisation. 2. Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases. 3. Symptomatic or rapid visceral progression 4. History of leptomeningeal disease 5. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) (patients with indwelling catheters such as PleurX® are allowed) 6. Uncontrolled tumour-related pain 7. Uncontrolled or symptomatic hypercalcemia (> 1.5 mmol/L ionised calcium or total calcium > 3 mmol/L or corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy 8. Malignancies other than TNBC within 5 years prior to randomisation, with the exception of those with a negligible risk of metastasis or death (e.g., 5-year OS rate > 90%) and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localised prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:time from randomisation to death from any cause. Measure:Overall survival (OS) Timepoints:Throughout the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:the proportion of patients alive 12 months after randomisation Measure:12-month survival rate Timepoints:Throughout the study ; Outcome name:the proportion of patients alive 18 months after randomisation Measure:18-month survival rate Timepoints:Throughout the study ; Outcome name:as determined by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), or death from any cause, whichever occurs first. Measure:Progression-free survival (PFS) Timepoints:Throughout study. ; Outcome name:as determined by the investigator according to RECIST 1.1 Measure:Objective response rate (ORR) Timepoints:Throughout study. ; Outcome name:as determined by the investigator according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1), or death from any cause, whichever occurs first. Measure:Duration of objective response (DoR) Timepoints:Throughout study. ; Outcome name:Measure of the proportion of patients with a CR or a PR or stable disease (SD) that lasts ≥ 6 months, as determined by the investigator according to RECIST 1.1 Measure:Clinical benefit rate (CBR) Timepoints:Throughout study. ; Outcome name:By a minimally important decrease of ≥10 points at two consecutive assessment time-points on the GHS/QoL scale (Items 29, 30) of the EORTC QLQ-C30 Measure:Time to deterioration (TTD) of GHS/QoL Timepoints:Throughout study. ; Outcome name:As determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 (NCI CTCAE 4.0) Measure:Incidence, nature and severity of adverse events (AEs) Timepoints:Throughout study. ; Outcome name:Peak and trough of atezolizumab concentrations in serum (Cmax and Cmin) at specified time points during treatment Measure:The PK profile Timepoints:Throughout study. ; Outcome name:Incidence o | — |
Countries
Bosnial and Herzegovina, China, Cuba, Germany, Indonesia, Kazakhstan, Korea South, Mexico, Panama, Philippines, Singapore, South Africa, Spain, Turkey, United States
Contacts
Public ContactCinthya Barrantes
ROCHE FARMA (PERU) S.A.
Outcome results
None listed