Titre |
A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer |
Protocole ID |
B-58/Monarch E/I3Y-MC-JPCF |
ClinicalTrials.gov ID |
NCT03155997 |
Type(s) de cancer |
Sein |
Phase |
Phase III |
Stade |
Adjuvant |
Type étude |
Traitement |
Médicament |
Abemaciclib |
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 Vaillancourt
418-682-7511 poste 2159
|
Statut |
Fermé |
Critètes d'éligibilité |
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Women (regardless of menopausal status) or men ≥18 years of age (or per local regulations).
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The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases.
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The participant must have undergone definitive surgical treatment for the current malignancy.
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The participant must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization.
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The participant must have axillary lymph node involvement by tumor and have one of the following indicating a higher risk of relapse:
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4 or more axillary lymph nodes involved with cancer
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Tumor size of at least 5 centimeters
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Grade 3 histology
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Ki67 index by central analysis of ≥20% on untreated breast tissue
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The participant must be randomized within 16 months from the time of surgery.
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If the participant is currently receiving or initiating standard adjuvant endocrine therapy at time of study entry, she/he must not have received more than 12 weeks of adjuvant endocrine therapy following his/her last non-endocrine therapy (surgery, chemotherapy, or radiation).
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Participants must have recovered from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery.
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Women of reproductive potential must have a negative blood pregnancy test and agree to use highly effective contraceptive methods.
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The participant has a Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
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The participant has adequate organ function.
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The participant is able to swallow oral medications.
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Critètes d'exclusion |
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Stage IV (M1), Stage IA, and lymph node negative breast cancer.
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Participants with a history of previous breast cancer are excluded, with the exception of lobular carcinoma in situ (LCIS) or ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago. Participants with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years are excluded.
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Females who are pregnant or lactating.
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The participant has previously received treatment with any CDK4 and CDK6 inhibitor.
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The participant is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate).
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The participant has previously received endocrine therapy for breast cancer prevention (tamoxifen or raloxifene or aromatase inhibitors).
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The participant has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
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The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden cardiac arrest. Any participant with a history of venous thromboembolism (VTE) (for example, deep vein thrombosis [DVT] of the leg or arm and/or pulmonary embolism) will be excluded.
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The participant has active bacterial infection, fungal infection, or detectable viral infection or viral load.
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The participant has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.
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