An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre or Postmenopausal Women With Hormone Receptor-positive (HR positive) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease

ovartis Healthcare Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

阶段: 3 期
状态: 进行中（未招募）
发起方

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

入选标准

•1. Patient is an adult, male or female >= 18 years old at the time of informed
•2.Male or female advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
•3.In the case of women, both pre or perimenopausal and postmenopausal patients are allowed to be included in this study; menopausal status is relevant for the requirement of goserelin to be used concomitantly with ribociclib and letrozole.
•a.Postmenopausal status is defined either by:
•I). Prior bilateral oophorectomy OR ii). Age more than or equal to 60 OR iii). Age less than 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range. If patient is taking tamoxifen or toremifene and age less than 60, then FSH and plasma estradiol levels should be in post-menopausal range per local normal range.
•Note: For women with therapy-induced amenorrhea, serial measurements of FSH and or estradiol are needed to ensure menopausal status.
•b.Premenopausal status is defined as either:
•I). Patient had last menstrual period within the last 12 months, OR ii). If on tamoxifen or toremifene within the past 14 days, plasma estradiol and FSH must be in the premenopausal range per local normal range, OR iii). In case of therapy induced amenorrhea, plasma estradiol and or FSH must be in the premenopausal range per local normal range.
•c.Perimenopausal status is define as neither premenopausal nor postmenopausal Note: Throughout this document, perimenopausal and premenopausal status is grouped together and referred as Premenopausal
•4.Patient has a histologically and or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.
•5.Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1plus or 2plus. If IHC is 2plus, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
•6.Patient has an Eastern Cooperative Oncology Group (ECOG) performance status more than or equal to 2
•7.Patient has adequate bone marrow and organ function as defined by ALL of the following laboratory values (as assessed by local laboratory):
•a.Absolute neutrophil count more than or equal to 1.5 Ã? 10 raised to 9 per L
•b.Platelets more than or equal to 100 Ã? 10 raised to 9 per L
•c.Hemoglobin more than or equal to 9.0 g per dL
•Potassium, sodium, calcium corrected for serum albumin and magnesium within normal limits or corrected to within normal limits with supplements before first dose of the study medication
•d.INR less than or equal to 1.5
•e.Serum creatinine less than or equal to 1.5 mg per dl or creatinine clearance more than or equal to 50 mL per min
•f.In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be below 2.5 Ã? ULN. If the patient has liver metastases, ALT and AST should be less than 5 Ã? ULN.
•g.Total serum bilirubin less than ULN; or total bilirubin less than or equal to 3.0 Ã? ULN with direct bilirubin within normal range in patients with well documented Gilberts Syndrome
•8.Patient must have a 12-lead ECG with ALL of the following parameters at screening:

排除标准

•1. Patient has a known hypersensitivity to any of the excipients of ribociclib or letrozole
•2. Patient who received any CDK4 6 inhibitor
•3. Patient who received any prior systemic hormonal therapy for advanced breast cancer; no more than one prior regimen of chemotherapy for the treatment of metastatic disease is permitted
•4. Patient is concurrently using other anti cancer therapy.
•5. Patient has had major surgery within 14 days prior to starting study drug or
•has not recovered from major side effects.
•6. Patient who has not had resolution of all acute toxic effects of prior anti cancer
•therapy to NCI CTCAE version 4.03 Grade less than or equal to 1 (except alopecia or other
•toxicities not considered a safety risk for the patient at investigators discretion).
•7. Patient who has received radiotherapy less than or equal to 4 weeks or limited field radiation for palliation less than or equal to 2 weeks prior to start of treatment, and who has not recovered to grade 1 or better from related side effects of such therapy (with the exception
•of alopecia) and or from whom more than or equal to 25 percent (Ellis R E 1961) of the bone marrow
•was irradiated.
•8. Patient has a concurrent malignancy or malignancy within 3 years prior to
•starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer
•9. Patient with central nervous system metastases unless they meet all of the following criteria
•At least 4 weeks from prior therapy for CNS disease completion including
•radiation and or surgery to starting the study treatment.
•Clinically stable CNS lesions at the time of study treatment initiation and not receiving steroids and or enzyme inducing anti epileptic medications for the management of brain metastases for at least 2 weeks.
•10. Patient has impairment of gastrointestinal (GI) function or GI disease that may
•significantly alter the absorption of the study drugs (e.g ulcerative diseases,
•uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small
•bowel resection)
•11. Patient has a known history of HIV infection (testing not mandatory)
•12. Patient has any other concurrent severe and or uncontrolled medical condition
•that would, in the investigators judgment, cause unacceptable safety risks,contraindicate patient participation in the clinical study or compromise
•compliance with the protocol (e.g. chronic pancreatitis, chronic active
•hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections,
•13. Clinically significant, uncontrolled heart disease and/or cardiac repolarization
•abnormalities, including any of the following:
•a. History of acute coronary syndromes (including myocardial infarction,
•unstable angina, coronary artery bypass grafting, coronary angioplasty, or
•stenting) or symptomatic pericarditis within 6 months prior to screening
•b. History of documented congestive heart failure (New York Heart
•Association functional classification III-IV)
•Documented cardiomyopathy
•c. Clinically significant cardiac arrhythmias (e.g. ventricular tachycardia),
•complete left bundle branch block, high-grade AV block (e.g. bifascicular
•block, Mobitz type II and

研究者

发起方

ovartis Healthcare Pvt Ltd

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