EUCTR2018-002514-12-IT进行中（未招募）1 期
Phase II, multicenter, single arm trial to assess the feasibility of first line ribociclib in combination with a non steroidal aromatase inhibitor in elderly patients with hormone receptor positive/HER2 negative advanced breast cancer FACILE: FeAsibility of first-line riboCIclib in oLdEr patients with advanced breast cancer - FACILE
FONDAZIONE SANDRO PITIGLIANI PER LA LOTTA CONTRO I TUMORI - ONLUS0 个研究点目标入组 194 人开始时间: 2021年1月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 194
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.Patients male or female, aged 70 years-old or older at the time of informed consent.
- •2.Patients with advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
- •3.Measurable or not measurable but evaluable disease according to RECIST criteria 1.1
- •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 a 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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 194
排除标准
- •Patients eligible for this study must not meet any of the following criteria:
- •1.Patient has received prior treatment with chemotherapy or hormonal therapy (except for neoadjuvant/ adjuvant chemotherapy), or any CDK4/6 inhibitor.
- •-Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy 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.
- •2.Patient has a known hypersensitivity to any of the excipients of ribociclib or NSAI
- •3.Patient in concurrently using other anti-cancer therapy.
- •4.Patient who has not had resolution of all acute toxic effects of prior anti-cancer therapy to NCI CTCAE version 5.0 Grade = 1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).
- •5.Patient who has received extended-field radiotherapy = 4 weeks or limited field radiation 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 investigator’s discretion). Patient from whom = 25% of the bone marrow has been previously irradiated are also excluded
- •6.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.
研究者
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