A Study of the Efficacy and Safety of Atezolizumab Plus Chemotherapy for Patients with Early Relapsing Recurrent Triple-Negative Breast Cancer
- Conditions
- Triple-Negative Breast Cancer (TNBC)MedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2016-005119-42-PL
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 572
- Male or female >= 18 years of age
- Histologically confirmed TNBC that is either locally recurrent, inoperable and cannot be treated with curative intent or is metastatic
- Prior treatment with an anthracycline and taxane
- Documented disease progression occurring within 12 months (<12 months) from the last treatment with curative intent
Have not received prior chemotherapy or targeted systemic therapy
for their locally advanced inoperable or metastatic recurrence . China
Population only: Chinese traditional medicines with an approved
indication for cancer treatment are permitted as long as the last
administration occurred at least 2 weeks prior to randomisation
- Measurable or non-measurable disease, as defined by Response
Evaluation Criteria in Solid Tumors (RECIST) 1.1
- Availability of a representative formalin-fixed paraffin-embedded
(FFPE) tumor block (preferred) or at least 17 unstained slides, obtained
from relapsed metastatic or locally advanced diseases may be submitted,
if clinically feasible, with an associated pathology report, if available. If a fresh tumor is not clinically feasible, either the diagnosis sample, the primary surgical resection sample or the most
recent FFPE tumor biopsy sample should be used.
- Eastern Cooperative Oncology Group performance status 0-1
- Life expectancy >= 12 weeks
- Adequate haematologic and end-organ function, Negative human
immunodeficiency virus (HIV) test at screening
- Negative hepatitis B surface antigen (HBsAg) test at screening
- Negative total hepatitis B core antibody (HBcAb) test at screening, or
positive HBcAb test followed by a negative hepatitis B virus (HBV) DNA
test at screening
- Negative hepatitis C virus (HCV) antibody test at screening, or
positive HCV antibody test followed by a negative HCV RNA test at
screening
- The HCV RNA test will be performed only for patients who have a
positive HCV antibody test
- For women of childbearing potential: agreement to remain abstinent
(refrain from heterosexual intercourse) or use a contraceptive method
with a failure rate of <=1% per year during the treatment period and for
at least 5 months after the final dose of atezo or 6 months after the last
dose of capecitabine. Women must refrain from donating
eggs during the same time period
- For men: agreement to remain abstinent (refrain from heterosexual
intercourse) or use a condom, and agreement to refrain from
donating sperm, with female partners of childbearing potential or
pregnant female partners, men must remain abstinent or use a condom
during the treatment period and for at least 3 months after last dose of
capecitabine or 6 months after the last dose of carboplatin/gemcitabine
to avoid exposing the embryo.
-For patients enrolled after the recruitment of all-comers is complete:
PD-L1-positive tumour status (assessed centrally prior to
randomisation), defined as PD-L1 expression on tumour-infiltrating
immune cells of 1% or greater.
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 486
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 86
- 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
- Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- Symptomatic or rapid visceral progression
- History of leptomeningeal disease
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Uncontrolled tumour-related pain
- Uncontrolled or symptomatic hypercalcemia or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy
- 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)
- Significant cardiovascular disease
- Presence of an abnormal ECG that is clinically significant in the investigator’s opinion
- Severe infection requiring oral or IV antibiotics within 4 weeks prior to randomisation, including but not limited to hospitalization for complications of infection, bacteraemia, or severe pneumonia
- Current treatment with anti-viral therapy for HBV
- Major surgical procedure within 4 weeks prior to randomisation or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis
- Treatment with investigational therapy within 28 days prior to randomisation
- Pregnant or lactating, or intending to become pregnant during or
within 5 months after the last dose of study treatmentatezo, or within 6
months after the last dose of capecitabine, whichever is later
History of autoimmune disease
- 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 computerised tomography (CT) scan
-Receipt of a live, attenuated vaccine within 4 weeks prior to
randomisation or anticipation that a live, attenuated vaccine will be
required during atezolizumab/placebo treatment or within 5 months
after the last dose of atezolizumab/placebo
-Prior treatment with CD137 agonists, anti-PD-1, or anti-PD-L1
therapeutic antibody or pathway targeting agents
-Treatment with systemic immunostimulatory agents (including but not
limited to interferons or interleukin [IL]-2) within 4 weeks or five half
lives
of the drug (whichever is longer) prior to randomisation
-Treatment with systemic corticosteroids or other systemic
immunosuppressive medications (including but not limited to
prednisone, dexamethasone, cyclophosphamide, azathioprine,
methotrexate, thalidomide, mycophenolate, and anti tumour necrosis
factor [TNF] agents) within 2 weeks prior to initiation of study
treatment, or anticipated requirement for systemic immunosuppressive
medications during the trial.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method