| Eligibility |
Inclusion Criteria:
- Women aged = 18 years who have provided written informed consent
- Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER,
and PR expression)
- No prior chemotherapy, experimental or targeted systemic therapy for inoperable
locally advanced or metastatic TNBC. Prior chemotherapy (including taxanes) in the
neoadjuvant or adjuvant setting is allowable if treatment was completed =12 months
prior to enter the compassionate use program
- PD-L1-positive tumour status defined as PD-L1 expression =1% on tumour-infiltrating
immune cells as percentage per tumour area, assessed by the Ventana PD-L1 (SP142)
assay based on the status of the primary tumor and/or the biopsy of metastatic disease
before starting the treatment. Samples should be assessed by a qualified laboratory
and different assays are not acceptable
- Patients eligible for ongoing atezolizumab clinical trials from which they may benefit
are excluded
- Eligible for taxane monotherapy (i.e., absence of rapid clinical progression,
life-threatening visceral metastases, or the need for rapid symptom and/or disease
control)
- 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 the following laboratory
results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1)
- ANC =1500 cells/µL (without granulocyte colony-stimulating factor [G-CSF] support
within 2 weeks prior to Cycle 1, Day 1);
- Lymphocyte count =500/µL; Platelet count =100,000/µL (without transfusion within 2
weeks prior to Cycle 1, Day 1);
- Hemoglobin =9.0 g/dL; AST, ALT, and alkaline phosphatase =2.5x the upper limit of
normal (ULN), with the following exceptions:
- Patients with documented liver metastases: AST and ALT =5x ULN
- Patients with documented liver or bone metastases: alkaline phosphatase = 5x ULN
- Serum bilirubin =1.25x ULN (patients with known Gilbert disease who have serum
bilirubin level =3x ULN may be enrolled)
- INR and aPTT =1.5x ULN (this applies only to patients who are not receiving
therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be
on a stable dose)
- Calculated creatinine clearance =30 mL/min
- Absence of a positive test for HIV, active hepatitis B or hepatitis C, active
tuberculosis
- Absence of significant cardiovascular disease (New York Heart Association (NYHA)
cardiac disease (Class II or greater), myocardial infarction within 3 months prior to
treatment start, unstable arrhythmias, or unstable angina. Patients with a known left
ventricular ejection fraction (LVEF) <40% will be excluded. Patients with known
coronary artery disease, congestive heart failure not meeting the above criteria, or
LVEF <50% must be on a stable medical regimen that is optimized in the opinion of the
treating physician, in consultation with a cardiologist if appropriate)
- No known untreated, symptomatic or corticosteroid-dependent brain metastases
- Patients with any history of immune deficiencies or autoimmune disease are excluded
from the treatment. Possible exceptions could be autoimmune-mediated hypothyroidism on
a stable dose of thyroid replacement hormone, controlled type 1 diabetes mellitus on a
stable insulin dosing regimen, eczema, psoriasis, lichen simplex chronicus or vitiligo
with dermatologic manifestations only
- Patients must not be administered systemic immunostimulatory agents within 4 weeks or
systemic immunosuppressive medications within 2 weeks prior to start the treatment
- Patients must agree not to receive live, attenuated vaccine (e.g., FluMist®) within 28
days prior to the first dose of study treatment (Cycle 1, Day 1), during treatment, or
within 5 months following the last dose of atezolizumab
- No known hypersensitivity or allergy to nab-paclitaxel, to any of the excipients, to
biopharmaceuticals produced in Chinese hamster ovary cells, or to any component of the
atezolizumab formulation
- Pregnancy or lactation are general medical exclusion criteria from the treatment
- Women of child bearing potential must agree to either use a contraceptive method with
a failure rate of = 1% per year or to remain abstinent (refrain from heterosexual
intercourse) during the treatment period and for at least 5 months after the last dose
of atezolizumab or 1 month after the last dose of nab-paclitaxel, whichever is later.
For definition of postmenopausal status see the study protocol
- Women of child bearing potential must have a negative serum pregnancy test result
prior to start the treatment
Esclusion Criteria:
- Patients who have not completed 1 cycle of treatment
|
