| Titre |
A phase III, double-blind, placebo controlled, randomized study of taselisib plus fulvestrant versus placebo plus fulvestrant in postmenopausal women with estrogen receptor-positive and her2-negative locally advanced or metastatic breast cancer who have disease recurrence or progression during or after aromatase inhibitor therapy |
| Protocole ID |
G029058 (SANDPIPER) |
| ClinicalTrials.gov ID |
NCT02340221 |
| Type(s) de cancer |
Sein |
| Phase |
Phase III |
| Stade |
Maladie avancée ou métastatique |
| Type étude |
Traitement |
| Médicament |
taselisib |
| 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 Louise Provencher
|
| Coordonnateur(trice) |
Nathalie Carmichael
418-682-7511 poste 4551
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
-
Postmenopausal women with histologically or cytologically confirmed locally advanced or metastatic estrogen-receptor positive (ER+) breast cancer
-
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
-
Endocrine therapy (e.g., fulvestrant) is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study
-
Radiologic/objective evidence of recurrence or progression to the most recent systemic therapy for breast cancer
-
Recurrence or progression during or after aromatase inhibitor
-
Evaluable or measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
-
Consent to provide tumor tissue (block or a minimum of 20 slides) from the most recent tumor tissue for PIK3CA-mutation testing; a valid cobas® PIK3CA mutation result by central testing is required
-
Adequate hematologic and end-organ function within 28 days prior to treatment initiation
|
| Critètes d'exclusion |
-
HER2-positive disease by local laboratory testing (immunohistochemistry [IHC] 3+ staining or in situ hybridization positive)
-
Prior treatment with fulvestrant
-
Prior treatment with a PI3K inhibitor, mTOR inhibitor (e.g. everolimus), or AKT inhibitor
-
Prior anti-cancer therapy within 2 weeks prior to Day 1 of Cycle 1
-
Prior radiation therapy within 2 weeks prior to Day 1 of Cycle 1
-
All acute treatment-related toxicity must have resolved to Grade
-
Prior treatment with > 1 cytotoxic chemotherapy regimen for metastatic breast cancer
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Concurrent hormone replacement therapy
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Known untreated or active central nervous system (CNS) metastases
-
Type 1 or Type 2 diabetes mellitus requiring anti-hyperglycemic medications
-
History of inflammatory bowel disease or active bowel inflammation
-
Clinically significant cardiac or pulmonary dysfunction
-
Clinically significant history of liver disease, including cirrhosis, current alcohol abuse, or current known active infection with HIV, hepatitis B or C virus
|
Groupe d'étude en oncologie du Québec