| Titre |
Randomized, OpEn-Label, Active-ContrOl Trial of SPI-2012 (Eflapegrastim) Versus Pegfilgrastim in the Management of Chemotherapy-Induced Neutropenia in Early-Stage BReast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) (RECOVER) |
| Protocole ID |
RECOVER ADVANCE2 (SPI-GCF-302) |
| ClinicalTrials.gov ID |
NCT02953340 |
| Type(s) de cancer |
Sein |
| Phase |
Phase III |
| Stade |
Adjuvant |
| Type étude |
Support |
| Médicament |
Eflapegrastim vs Pegfilgrastim |
| 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 Brigitte Poirier
|
| Coordonnateur(trice) |
Édith Duchesneau
418-525-4444 x82697
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
-
New diagnosis of histologically confirmed early-stage breast cancer (ESBC), defined as operable Stage I to Stage IIIA breast cancer.
-
Candidate to receive adjuvant or neo-adjuvant TC chemotherapy.
-
ECOG ≤2.
-
ANC ≥1.5×10^9/L.
-
Platelet count ≥100×10^9/L.
-
Hemoglobin >9 g/dL.
-
Calculated creatinine clearance > 50 mL/min.
-
Total bilirubin ≤1.5 mg/dL.
-
AST/SGOT and ALT/SGPT ≤2.5×ULN. (upper limit of normal)
-
Alkaline phosphatase ≤2.0×ULN.
|
| Critètes d'exclusion |
-
Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life-threatening disease.
-
Known sensitivity to E. coli derived products.
-
Concurrent adjuvant cancer therapy.
-
Locally recurrent/metastatic.
-
Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug.
-
Active infection or any serious underlying medical condition, which would impair the ability of the patient to receive protocol treatment.
-
Prior bone marrow or stem cell transplant.
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Used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study.
-
Prior radiation therapy within 30 days prior to enrollment.
-
Major surgery within 30 days prior to enrollment.
|
Groupe d'étude en oncologie du Québec