| Titre |
A Phase III, Multicenter, Randomised, Double-Blind, Placebo-Controlled Study of Atezolizumab (Anti-Pd-L1 Antibody) in Combination With Paclitaxel Compared With Placebo With Paclitaxel for Patients With Previously Untreated Inoperable Locally Advanced or Metastatic Triple Negative Breast Cancer |
| Protocole ID |
MO39196 (IMpassion131) |
| ClinicalTrials.gov ID |
NCT03125902 |
| Type(s) de cancer |
Sein |
| Phase |
Phase III |
| Stade |
Maladie avancée ou métastatique |
| Type étude |
Traitement |
| Médicament |
Atezolizumab et Paclitaxel |
| Institution |
CHU DE QUEBEC – UNIVERSITE LAVAL
 HOPITAL DU SAINT-SACREMENT
1050 Ch Ste-Foy, Québec, QC, G1S 4L8
|
| Ville |
Québec |
| Investigateur(trice) principal(e) |
Dre Catherine Doyle
|
| Coordonnateur(trice) |
Édith Duchesneau
418-525-4444 x82697
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
-
Participants with locally advanced or metastatic, histologically documented TNBC (absence of human epidermal growth factor receptor 2 [HER2], estrogen receptor [ER], and progesterone receptor [PR] expression), not amenable to surgical therapy
-
Participants eligible for taxane monotherapy
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No prior chemotherapy or targeted systemic therapy (including endocrine therapy) for inoperable locally advanced or metastatic TNBC
-
Availability of formalin-fixed paraffin-embedded (FFPE) tumor block (preferred) or at least 25 unstained slides, collected ≤3 months prior to randomization, with an associated pathology report
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Eastern Cooperative Oncology Group performance status of 0 or 1
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Life expectancy at least 12 weeks
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Measurable disease, as defined by RECIST v1.1
-
Adequate hematologic and end-organ function
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Women of child bearing potential must have a negative serum pregnancy test result within 7 days prior to initiation of study drug
-
For men and women of child bearing potential: agreement to remain abstinent or use protocol defined contraceptive measures during the treatment period and for at least 5 months after the last dose of atezolizumab/placebo, or for at least 6 months after the last dose of paclitaxel
|
| Critètes d'exclusion |
-
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 at least 2 weeks prior to randomization
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Known central nervous system (CNS) disease, except for treated asymptomatic CNS metastases
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Leptomeningeal disease
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Uncontrolled pleural effusion, pericardial effusion, or ascites
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Uncontrolled tumor-related pain, or uncontrolled hypercalcemia or clinically significant (symptomatic) hypercalcemia
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Malignancies other than TNBC within 5 years prior to randomization, 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, non-melanoma skin carcinoma, or Stage I uterine cancer)
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Pregnant or breast-feeding women, or intending to become pregnant during the study
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Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results, including significant liver disease, cardiovascular disease, and presence of an abnormal electrocardiogram (ECG)
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Serious infection requiring antibiotics within 2 weeks prior to randomization, including but not limited to infections requiring hospitalization or IV antibiotics, such as bacteremia, or severe pneumonia
-
Major surgical procedure within 4 weeks prior to randomization or anticipation of the need for a major surgical procedure during the study other than for diagnosis
-
Treatment with investigational therapy within 30 days prior to initiation of study treatment
-
History of hypersensitivity reactions to study drug or any component of the study drug formulation
|
Groupe d'étude en oncologie du Québec