EUCTR2016-003467-19-CZ进行中（未招募）1 期
COMPLEEMENT-1: 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/postmenopausal women with hormone receptorpositive (HR+) HER2-negative (HER2-) advanced breast cancer (aBC) with no prior hormonal therapy for advanced disease - COMPLEEMENT-1
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patient is an adult, male or female = 18 years old at the time of informed consent
- •NOTE: Sexually active males should use a condom during intercourse while taking drug and for 21 days after stopping medication and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid
- •2. Male or female with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
- •3. In the case of women, both pre/perimenopausal and postmenopausal patients are allowed to be included in this study; menopausal status is relevant for the requirement of goserelin or leuprolide to be used concomitantly with ribociclib and letrozole..
- •a) Postmenopausal status is defined either by:
- •?Prior bilateral oophorectomy OR
- •?Age = 60 OR
- •?Age < 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 < 60, then FSH and plasma estradiol levels should be in post-menopausal range per local normal range.
- •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 defined as neither premenopausal nor postmenopausal
- •4. Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.A confirmatory biopsy is not required.
- •5. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, 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 = 2
- •7. Patient has adequate bone marrow and organ function as defined by ALL of the following laboratory values (as assessed by local laboratory):
- •?Absolute neutrophil count = 1.5 × 109/L
- •?Platelets = 100 × 109/L
- •?Hemoglobin = 9.0 g/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
- •?INR = 1.5
- •?Serum creatinine < 1.5 mg/dl or creatinine clearance = 50 mL/min
- •?In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be below 2.5 × ULN. If the patient has liver metastases, ALT and AST should be < 5 × ULN.
- •?Total bilirubin < ULN except for patients with Gilbert's Syndrome who may only be included if the total bilrubin is = 3.0 × ULN or direct bilirubin = 1.5 × ULN
- •8. Patient must have a 12-lead ECG with ALL of the following parameters at screening:
- •?QTcF interval at screening < 450 msec (using Fridericia’s correction)
- •?Resting heart rate = 50 bpm
- •9. Patient must be able to swallow ribociclib and letrozole tablets
- •10. Patient has signed informed consent obtained before any trial-related activities and according to local guidelines
- •11. Patients must be a
排除标准
- •1. Patient has a known hypersensitivity to any of the excipients of ribociclib or letrozole, including peanuts and soy
- •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
- •?Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) included letrozole or anastrozole the
- •disease free interval must be greater than 12 months from the completion of treatment until study entry.
- •?Patients who received = 28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial are eligible.
- •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 = 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).
- •7. Patient who has received extended-field radiotherapy = 4 weeks or limited field radiotherapy for palliation = 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 or other toxicities not considered a safety risk for the patient at the investigator's discretion). Patients from whom = 25% (Ellis R E 1961) of the bone marrow has been previously irradiated are also excluded.
- •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 (CNS) 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., uncontrolled 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 investigator’s 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, etc.)
- •13. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormalities, including but not limited to any of the following:
- •?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
- •?History of documented congestive hear
研究者
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