Previously untreated metastatic triple negative breast cancer MedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: MPDL3280A-RO5541267-F-03
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: not yet assigned
Current Sponsor code: RO5541267
Other descriptive name: MPDL3280A
Concentration
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Women aged = 18 years • Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression) • No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC • Representative FFPE tumor specimens in paraffin blocks (preferred) or at least 15 unstained slides, with an associated pathology report documenting ER, PR, and HER2 negativity •A tumor specimen obtained from metastatic or locally advanced disease (if applicable) must be submitted if clinically feasible • ECOG performance status of 0 or 1 • Life expectancy = 12 weeks • Measurable disease, as defined by RECIST v1.1 •Adequate hematologic and end-organ function defined by laboratory results obtained within 2 weeks prior to first study treatment. •Women of child bearing potential must agree to use adequate contraception (double barrier methods of birth control or abstinence) prior to study entry, for the duration of study treatment, and for at least 5 months after the last dose of study treatment. • Patients who are not postmenopausal (= 12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative serum pregnancy test result within 14 days prior to initiation of study drug Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 540 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 360
Exclusion criteria
Exclusion criteria: • 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 randomization • Known CNS disease, except for treated asymptomatic CNS metastases • Leptomeningeal disease • Uncontrolled pleural effusion, pericardial effusion, or ascites (indwelling drainage catheters are permitted) • Uncontrolled tumor-related pain • Uncontrolled hypercalcemia •Pregnancy or lactation • Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome) • Significant cardiovascular disease • Severe infection within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia • History of autoimmune disease (Autoimmune-related hypothyroidism on a stable dose of thyroid replacement hormone and Type 1 diabetes mellitus on an stable insulin regimen may be eligible for this study) • Prior allogeneic stem cell or solid organ transplantation • History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted. • Positive test for HIV • Active hepatitis B or hepatitis C •Active tuberculosis •Treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [TNF] agents) within 2 weeks prior to randomization, or anticipated requirement for systemic immunosuppressive medications during the trial. Low dose steroids for nausea, adrenocortical insufficiency or orthostatic hypotension, IV contrast allergic reactions and inhaled corticosteroids are permitted.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To evaluate the efficacy of Atezolizuzmab + nab-paclitaxel compared with placebo + nab-paclitaxel as measured by progression-free survival (PFS; per investigator assessment using Response Evaluation Criteria in Solid Tumors [RECIST] v1.1) • To evaluate the efficacy of atezolizumab + nab-paclitaxel compared with placebo + nab-paclitaxel as measured by overall survival (OS);Secondary Objective: • To evaluate the efficacy of atezolizumab + nab-paclitaxel compared with placebo + nab-paclitaxel as measured by objective response rate (ORR; per investigator assessment using RECIST v1.1) • To evaluate the efficacy of atezolizumab + nab-paclitaxel compared with placebo + nab-paclitaxel as measured by duration of objective response (DOR; per investigator using RECIST v1.1) among patients with an objective response • To evaluate patient-reported outcomes (PROs) of health status/health-related quality of life (HRQoL) associated with atezolizumab + nab-paclitaxel compared with placebo + nab-paclitaxel, as measured by the time to deterioration (TTD) in Items 29 and 30 of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30);Primary end point(s): Progression free survival (PFS) ;Timepoint(s) of evaluation of this end point: Tumor assessments will be performed every 8 weeks for the first 12 months and every 12 weeks thereafter until disease progression or treatment discontinuation, whichever is later | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Overall survival (OS), Objective response rate (ORR) and duration of objective response (DOR), Patient reported outcomes (PRO) of health status and health quality of life (HRQoL) ;Timepoint(s) of evaluation of this end point: OS - every 3 months until death, withdrawal of consent, loss to follow-up, or study termination by the Sponsor ORR and DOR – tumor assessments will be performed every 8 weeks for the first 12 months and every 12 weeks thereafter until disease progression or treatment discontinuation, whichever is later PRO and HRQoL - at baseline (Cycle 1,Day 1); at Day 1 of each subsequent cycle; and at the treatment discontinuation visit. In addition, all patients will complete the PRO questionnaires every 28 days for 1 year after treatment discontinuation, regardless of whether the patient is receiving subsequent anti-cancer therapy. | — |
Countries
Australia, Austria, Belgium, Canada, Czechia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Italy, Korea, Republic of, Latvia, Norway, Poland, Portugal, Romania, Slovenia, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactTrial Information Support Line-TISL
Genentech Inc. c/o F. Hoffmann La Roche Ltd
Outcome results
None listed