EUCTR2018-002990-24-IT进行中（未招募）1 期
Elacestrant Monotherapy vs. Standard of Care for the Treatment of Patients with ER+/HER2- Advanced Breast Cancer Following CDK4/6 Inhibitor Therapy: A Phase 3 Randomized, Open-Label, Active-Controlled, Multicenter Trial (EMERALD) - EMERALD
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
- 466
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
- •- Subjects with histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally advanced
- •disease not amenable to resection or radiation therapy with curative intent or metastatic disease not amenable to curative therapy
- •- Subjects must be appropriate candidates for endocrine monotherapy
- •- Subjects must have one of the terms as defined by RECIST v1.1 and confirmed by central radiology review prior to randomization:
- •a. Measurable disease
- •b. Bone-only disease with evaluable lesions. Subjects must have at least
- •1 lytic or mixed lytic-/blastic bone lesion; blastic- lesions only are not
- •evaluable and allowed. Subjects who have had prior radiation to bone must have at least one evaluable
- •lesion in a non-irradiated area
- •- Female or male subjects age = >18 years
- •- Female subjects must be postmenopausal, defined as:
- •a. Documented bilateral surgical oophorectomy
- •b. Age > = 60 years with amenorrhea = > 1 year since last menses
- •c. Age < 60 years with amenorrhea = > 1 year since last menses with no alternative pathological or physiological cause (including chemotherapy,
- •treatment with tamoxifen or toremifene, or a GnRH agonist), and serum estradiol and FSH level within the laboratory reference range for
- •postmenopausal women
- •d. Age < 60 years with tamoxifen or toremifene therapy within the last 12 months, with documentation of 12 months of amenorrhea prior to
- •tamoxifen or toremifene therapy, and serum estradiol and FSH levels within the laboratory reference range for postmenopausal women
- •- Male subjects:
- •a. Must have suppression of testicular hormone production through chemical ablation with an approved GnRH agonist, starting at least six
- •weeks prior to study entry and continuing without interruption for the duration of protocol treatment (unless they have undergone prior
- •orchiectomy). Note: GnRH agonists should be administered as per local standard of care and should be documented as concomitant medication
- •b. Must, even if surgically sterilized (ie, status post-vasectomy):
- •i. Agree to practice highly effective barrier contraception (use condoms) during the entire study treatment period and through 120 days after the
- •last dose of study drug. For subjects (who have not undergone vasectomy) with female partners of childbearing potential, the subject and his partner must in addition to condoms, use highly effective contraceptive measures when engaging in sexual intercourse throughout the study, and for at least
- •120 days after the last dose of study drug (eg, oral contraceptive and condoms, intrauterine device (IUD) and condoms, diaphragm with
- •spermicide and condoms, other forms of contraception must be approved by the medical monitor) OR Agree to practice true abstinence during the
- •entire study treatment period and through 120 days after the last dose of study drug.
- •Note: Abstinence should only be used as a contraceptive method if it is in line with the subject's usual and preferred lifestyle. Periodic abstinence (calendar symptothermal, post-ovulation methods) is not an acceptable method of contraception.
- •ii. Agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of the study drugs
- •Please refer to the Protocol for further inclusion criteria.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 233
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjec
排除标准
- •- Prior treatment with elacestrant or investigational SERD or ER antagonist (eg, D-0502, GDC-0810, GDC-0927, GDC-9545, G1T-48, LSZ102, AZD9496, SAR439859, ZN-c5, H3B-6545, bazedoxifene, lasoxifene
- •- Prior anticancer or investigational drug treatment
- •- Presence of symptomatic metastatic visceral disease, including but not limited to, extensive hepatic involvement, untreated or progressive central nervous system (CNS) metastases, or symptomatic pulmonary lymphangitic spread. Subjects with discrete pulmonary parenchymal metastases are eligible, provided their respiratory function is not significantly compromised as a result of disease in the opinion of the Investigator. Subjects with previously treated CNS metastases are eligible provided that that all known lesions were previously treated, they have completed
- •radiotherapy at least 28 days prior to first dose of study drug, are clinically stable, and require no steroid medication. If anti-convulsant medication is required, subjects must be stable on a non-enzyme inducing anticonvulsant regimen
- •- Subjects with an intact uterus with a history of endometrial intraepithelial neoplasia (atypical endometrial hyperplasia or highergrade lesion)
- •- Diagnosis of any other malignancy within five years before enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix or second primary breast cancer
- •- Any of the following within six months before enrollment: myocardial infarction, severe/unstable angina, ongoing cardiac dysrhythmias of NCI CTCAE v5.0 > = Grade 2, prolonged QTcF = Grade 2 (ie, >480 msec), uncontrolled atrial fibrillation of any grade, coronary/peripheral artery bypass graft, heart failure > Class II as defined by the New York Heart Association (NYHA) guidelines (Appendix 5), or cerebrovascular accident including transient ischemic attack
- •- Subjects with abnormal coagulation profiles, or any history of coagulopathy within the past six months, including history of deep vein thrombosis (DVT) or pulmonary embolism. However, subjects with the following conditions will be allowed to participate: a.Subjects with adequately treated catheter-related venous thrombosis occurring more than one month prior to the first dose of study drug b.Subjects being treated with an anticoagulant, eg, warfarin or heparin, for a thrombotic event occurring more than six months before enrollment, or for an otherwise stable and allowed medical condition (eg, well controlled atrial fibrillation), provided dose and coagulation parameters (as defined by local standard of care) are stable for at least one month prior to the first dose of study drug, and provided that an AI would be an appropriate therapy for the subject
- •Please refer to the Protocol for further exclusion criteria.
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