| Titre |
A Double-Blind Placebo-Controlled Randomized Phase III Trial of Fulvestrant and Ipatasertib as Treatment for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor |
| Protocole ID |
MA.40 (Finer) |
| ClinicalTrials.gov ID |
NCT04650581 |
| Type(s) de cancer |
Sein |
| Phase |
Phase III |
| Type étude |
Clinique |
| Médicament |
Fulvestrant and Ipatasertib |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| Ville |
Montréal |
| Investigateur(trice) principal(e) |
Dr Jean-Pierre Ayoub
|
| Coordonnateur(trice) |
Ana Lydia Tkalec
514-890-8000 poste 14186
|
| Statut |
 Actif en recrutement |
| Critètes d'éligibilité |
- Histologically and/or cytologically confirmed ER positive, HER-2 negative breast cancer
- Female patients must be post-menopausal; female patients who are pre-menopausal must have ovarian suppression using LHRH agonist while on study
- Clinical and/or radiographic progression during treatment with or within 28 days after discontinuation of first line of treatment with a CDK 4/6 inhibitor and an aromatase inhibitor (AI) for advanced/metastatic disease
- Evidence of clinically and/or radiologically documented disease
- ≥ 18 years of age
- ECOG performance status of 0 or 1
-
No concurrent anti-cancer therapy and must satisfy the following criteria for previous therapy
- Must not have received more than one prior line of treatment with a CDK 4/6 inhibitor and an AI in the advanced disease setting.
- Treatment with CDK 4/6 inhibitor and AI must have been the most recent treatment prior to registration for this study
-
Adequate hematology and organ function, in the absence of growth factors
- Absolute neutrophils > 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin > 90 g/L
- Total Bilirubin ≤ 1.5 x ULN (upper limit of normal) or ≤ 3 x ULN if confirmed Gilbert's Syndrome
- ALT and AST ≤ 2.5 x ULN (or ≤ 5.0 x ULN if liver or bone metastasis)
- Alkaline phosphatase ≤ 2.0 x ULN (or ≤ 5.0 x ULN if liver metastases, ≤ 7.0 x ULN if bone metastasis)
- Fasting glucose ≤ 8.3 mmol/L
- HbA1c ≤ 7.5%
- Serum albumin ≥ 30 g/L
- INR ≤ 1.2
- Serum Creatinine or Creatinine clearance ≤ 1.5 x ULN or ≥ 50 mL/min; measured directly by 24-hour urine sampling or as calculated by Crockcroft and Gault equation
|
| Critètes d'exclusion |
- Untreated or symptomatic CNS metastases, radiation treatment for CNS metastases within 28 days
- Active inflammatory bowel disease, bowel inflammation, inability to swallow oral medication or GI condition that alters oral absorption
- Prior treatment with fulvestrant, selective estrogen receptor degraders (SERDs) or known inhibitors of the PI3K pathway including PI3K inhibitors, AKT inhibitors, or mTOR inhibitors
- Mean QT interval corrected for heart rate (QTc) ≥ 480 msec by ECG or history of familial long QT syndrome
- Active or uncontrolled infections or serious illnesses or medical conditions
- Clinically significant liver diseases
- History of lung disease or history of opportunistic infections
- Type 1 or Type 2 diabetes mellitus requiring insulin
- Grade ≥ 2 uncontrolled hypercholesterolemia or hypertriglyceridemia
- Known abnormalities in coagulation
- History of hypersensitivity to the study drugs or components
- Pregnant or lactating women
|
Groupe d'étude en oncologie du Québec