| Titre |
PALbociclib CoLlaborative Adjuvant Study: A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive (HR+) / Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Early Breast Cancer |
| Protocole ID |
(CCTG) MA.37/PALLAS |
| ClinicalTrials.gov ID |
NCT02513394 |
| Type(s) de cancer |
Sein |
| Phase |
Phase III |
| Stade |
Adjuvant |
| Type étude |
Traitement |
| Médicament |
Palbociclib et hormonothérapie |
| 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 Julie Lemieux
|
| Coordonnateur(trice) |
Isabelle Ouellet
418-682-7511 poste 4553
|
| Statut |
![]() Fermé |
| Critètes d'éligibilité |
-
Signed informed consent prior to study specific procedures.
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Age ≥18 years (or per national guidelines).
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Pre- and postmenopausal women or men with Stage II (Stage IIA limited to max. 1000 patients) or Stage III early invasive breast cancer
-
Patients with multicentric and/or multifocal and/or bilateral early invasive breast cancer are eligible if all histopathologically examined tumors meet pathologic criteria for ER+ and/or PR+ and HER2-.
-
Patients must have histologically confirmed ER+ and/or PR+, HER2-, early invasive breast cancer.
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Patients must have undergone breast surgery for the current malignancy. FFPE tumor tissue block must be confirmed to be received at the central sample repository prior to randomization.
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ECOG performance status 0-1.
-
Patients must be able and willing to swallow and retain oral medication.
-
Serum or urine pregnancy test must be negative in premenopausal women within 14 days of randomization, or in women with amenorrhea of less than 12 months at time of randomization.
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Patients who received neo/adjuvant therapy must be after last dose of chemotherapy and/or biologic therapy and must have sufficient resolution of side effects.
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Patients who received breast/axilla/post-mastectomy chest wall radiotherapy must be after last dose of radiotherapy and must have sufficient resolution of side effects.
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Patients must have sufficient resolution of any surgical side effects (no active wound healing complications).
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Patients must either be initiating or have already started adjuvant hormonal treatment.
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Patients who already received neo/adjuvant endocrine therapy are eligible as long as they are enrolled within 12 months of initial histological diagnosis and after completing no more than 6 months of adjuvant endocrine therapy.
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Absolute neutrophil count ≥ 1,500/µL
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Platelets ≥ 100,000/ mm3
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Hemoglobin ≥ 10g/dL
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Total serum bilirubin ≤ ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in patients with documented Gilbert's Syndrome.
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Aspartate amino transferase (AST or SGOT) and alanine amino transferase (ALT or SGPT) ≤ 1.5 × institutional ULN.
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Serum creatinine within normal institutional limits or creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with serum creatinine levels above institutional ULN.
|
| Critètes d'exclusion |
-
Concurrent therapy with other Investigational Products.
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Prior therapy with any CDK inhibitor.
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Patients with Stage I or IV breast cancer are not eligible.
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History of allergic reactions attributed to compounds of chemical or biologic composition similar to palbociclib.
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Patients receiving any medications or substances that are potent inhibitors or inducers of
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CYP3A isoenzymes within 7 days of randomization.
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Uncontrolled intercurrent illness that would limit compliance with study requirements.
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Pregnant women, or women of childbearing potential without a negative pregnancy test within 14 days prior to randomization.
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Patients with a history of any malignancy are ineligible
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Patients who previously received endocrine therapy within 5 years prior to diagnosis of the current malignancy.
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Patients on combination antiretroviral therapy.
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Patients with clinically significant history of any liver disease.
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Patients receiving concurrent exogenous hormone therapy (topical vaginal estrogen therapy is allowable).
|
Groupe d'étude en oncologie du Québec