None listed
Conditions
Interventions
Atezolizumab + Paclitaxel or Nab-paclitaxel. Type of group
Atezolizumab 840 mg administered via intravenous (IV) infusion on Days 1 and 15 of
every 28-day cycle in combination with one of the following two regimens (individually
selected by the investigator):
• Nab-paclitaxel* (100mg/m2
) administered via IV infusion on Days 1, 8 and 15 of every
28-day cycle
or
• Paclitaxel* (90mg/m2
) administered via IV infusion on Days 1, 8 and 15 of every 28-day
cycle.
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Inclusion criteria
Inclusion criteria: Patients must meet the following criteria for study entry: 1. Have provided written informed consent. 2. Female or male ≥ 18 years of age. 3. Ability to comply with the study protocol, in the investigator’s judgment. 4. Patients with unresectable locally advanced or metastatic, histologically documented TNBC (negative for HER2 and ER and PgR). 5. Patient with at least one specimen positive for PD-L1 status as determined by VENTANA PD-L1 SP142 Assay. 6. No prior chemotherapy, experimental or targeted systemic therapy for unresectable locally advanced or metastatic TNBC. 7. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2. 8. Life expectancy ≥ 12 weeks. 9. Measurable disease, as defined by RECIST v1.1. 10. Adequate haematologic and end-organ function, defined by the following laboratory results obtained within 14 days prior to the initiation of study treatment (Cycle 1, Day 1). See protocol for more detail.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from study entry: Cancer-Specific 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 the first dose of study treatment (Cycle 1, Day 1). 2. Leptomeningeal carcinomatosis or any symptomatic CNS metastases 3. Uncontrolled symptomatic pleural effusion, pericardial effusion, or ascites 4. Uncontrolled tumour-related pain 5. Uncontrolled hypercalcemia (> 1.5 mmol/L ionized calcium or calcium > 12 mg/dL or corrected serum calcium > ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy. 6. Malignancies other than TNBC within 5 years prior to the first dose of study treatment (Cycle 1, Day 1), with the exception of those with a negligible risk of metastasis or death and treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer). See protocol for more detail.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Primary Safety Endpoints: Incidence of treatment-emergent Grade≥3 AEs Incidence of treatment-emergent Grade≥2 imAEs . Measure:To evaluate the safety of atezolizumab when given in combination with nabpaclitaxel/ paclitaxel in patients with unresectable locally advanced or metastatic PD-L1-positive TNBC who have not received prior systemic cytotoxic therapy for locally advanced or metastatic TNBC. Timepoints:Throughout study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Secondary Safety Endpoints: Incidence of all treatment-emergent AEs Incidence of treatment-emergent SAEs. Measure:To further evaluate the safety of atezolizumab when given in combination with nab-paclitaxel/ paclitaxel in patients with unresectable locally advanced or metastatic PD-L1-positive TNBC who have not received prior systemic cytotoxic therapy for locally advanced or metastatic TNBC. Timepoints:Throughout study. | — |
Countries
Argentina, Chile, China, Czech Republic, France, Hungary, Italy, Mexico, Poland, Portugal, Slovakia, Slovenia, Spain
Contacts
Public ContactLizeth Perez
ROCHE FARMA (PERU) S.A.
Outcome results
None listed