EUCTR2016-004107-31-IT进行中（未招募）1 期
Randomized clinical trial of concomitant chemoendocrine therapy versus chemotherapy followed by endocrine therapy as first line treatment of luminal B metastatic breast cancer. - CHENDO
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI (IRST) S.R.L. IRCCS0 个研究点目标入组 300 人开始时间: 2018年1月31日最近更新:
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
- 300
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) Age = 18 years.
- •2) Male or female
- •3) Histological diagnosis of HER2-negative luminal breast cancer (ER >10% of tumor cells), determined by local laboratory on most recent available tumor tissue.
- •4) Locally advanced (not susceptible to locoregional therapy) or metastatic disease (herein globally defined as advanced breast cancer, ABC).
- •5) Candidate to chemotherapy-based treatment per the investigator best judgment; e.g. because of disease aggressiveness, short disease-free interval, elevated Ki67 [if available on a metastatic site], low expression of hormone receptors, extended visceral involvement, visceral involvement at risk for organ failure, uncontrolled symptoms), according to Associazione Italiana di Oncologia Medica (AIOM) Guidelines (2016 edition).
- •6) Postmenopausal women, or premenopausal women undergoing treatment with LHRH analog, or men (either receiving treatment with LHRH analog or not). Postmenopausal status is defined as:
- •a.bilateral, surgical oophorectomy
- •b.age =60 years
- •c.age <60 years, with amenorrhea >12 months and follicle-stimulating hormone (FSH), luteinizing hormone (LH) and estradiol concentrations within postmenopausal range
- •d.age <60 years and previous simple hysterectomy, with FSH, LH and estradiol levels within the post-menopausal range at two consecutive assessments two weeks apart.
- •7) Measurable disease according to RECIST 1.1 criteria or non measurable but evaluable lesions.
- •8) No prior chemotherapy for ABC. Up to two prior lines of endocrine therapy for ABC, as well as targeted therapies (such as palbociclib and/or everolimus or investigative targeted therapies) administered as part of a prior hormonal regimen for ABC, are allowed.
- •9) Eastern Cooperative Oncology Group performance status (ECOG-PS) =2
- •10) Adequate organ (renal, hepatic, bone marrow, cardiac) functions.
- •11) Female participants of child-bearing potential and male participants whose partner is of child bearing potential must be willing to use effective contraception during the study period and for 4 months thereafter. Effective contraception methods include: total abstinence (when this is in line with the preferred and usual lifestyle of the subject); tubal ligation; male sterilization; combination of the placement of an intrauterine device or intrauterine system and barrier methods of contraception with spermicidal suppository.
- •12) Participant is willing and able to give informed consent for participation in the study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1) Any prior chemotherapy for advanced breast cancer
- •2) Resistance to both non-steroidal and steroidal aromatase inhibitors, eg patients who progressed while on or within 12 months after the end of an aromatase inhibitor in the adjuvant setting and who progressed while on an aromatase inhibitor (of a different class) in the metastatic setting, or patients who progressed to both classes of aromatase inhibitors administered as two distinct lines of therapy for metastatic disease.
- •3) Active central nervous system metastases.
- •4) Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection (patients with history of hepatitis B must undergo prophylactic therapy with lamivudine or other agent according to infectious disease consultation), symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •5) Prior history of non-breast malignancy (except for adequately controlled basal cell carcinoma of the skin, carcinoma in situ of the cervix, in situ carcinoma of the bladder), unless treated with curative intent and disease free for at least 3 years.
研究者
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