NCT02035813已完成2 期
DETECT IV - A Prospective, Multicenter, Open-label, Phase II Study in Patients With HER2-negative Metastatic Breast Cancer and Persisting HER2-negative Circulating Tumor Cells (CTCs).
Prof. Wolfgang Janni1 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2014年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Progression free survival (PFS)
研究概览
简要总结
Several studies have indicated that determining prevalence and number of circulating tumor cells (CTCs) at various time points during treatment may be an effective tool for assessing treatment efficacy in metastatic breast cancer (MBC). However, even if the prognostic value of CTCs in MBC is well understood, the role of both CTC prevalence and CTC phenotype in predicting treatment response needs further investigation. DETECT IV is a prospective, multicenter, open-label, phase II study in patients with HER2-negative metastatic breast cancer and persisting HER2-negative circulating tumor cells (CTCs). Additional research on CTC dynamics and characteristics will provide a better understanding of the prognostic and predictive value of CTCs and is one step into a more personalized therapy for MBC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Both cohorts:
- •Indication for an endocrine therapy (Histological confirmation of estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) breast cancer).
- •Up to two lines of previous cytostatic treatment for MBC.
- •Any endocrine therapy in the history is allowed.
- •Disease progression following prior treatment with endocrine therapy (endocrine therapy does not have to be the last therapy before inclusion in the trial).
- •Postmenopausal women. The investigator must confirm postmenopausal status Postmenopausal status is defined either by
- •Age ≥ 55 years and one year or more of amenorrhea
- •- Age < 55 years and one year or more of amenorrhea and postmenopausal levels of FSH and LH
- •- Prior hysterectomy and has postmenopausal levels of FSH and LH
- •- Surgical menopause with bilateral oophorectomy
- •Everolimus cohort:
- •Cholesterol ≤ 2.0 × ULN
- •Ribociclib cohort:
- •Standard 12-lead ECG values assessed by the local laboratory:
- •- QTcF interval at screening < 450 msec (using Fridericia's correction)
- •- Resting heart rate 50-90 bpm
- •INR ≤ 1,5 (ribocilclib cohort)
- •Patients must have the following laboratory values within normal limits or corrected to within normal lim-its with supplemets before the first dose of study medication:
- •-Potassium
- •-Total calcium
- •For Eribulin only:
- •Either hormone-receptor negative MBC or hormone-receptor positive MBC with indication for chemotherapy
- •Up to three previous chemotherapy treatment lines for metastatic disease
- •In case of patients of child bearing potential:
- •Negative pregnancy test (minimum sensitivity 25IU/L or equivalent units of HCG) within 7 days prior to recruitment
- •Contraception by means of a reliable method (i.e. non-hormonal contraception, IUD, a dou-ble barrier method, vasectomy of the sexual partner, complete sexual abstinence). Patient must consent in maintaining such contracep-tion until 3 months after completion of study treatment
排除标准
- •In General for both study cohorts:
- •Treatment with other investigational agents of any type or anticancer therapy during the trial, within 2 weeks prior to the start of treatment.
- •Adverse events due to prior anticancer therapy which are > Grade 1 (NCI CTCAE) and therapeutically relevant at time of treatment start.
- •Known HIV infection.
- •Current active hepatitis B or C, cliniclally relevant known liver dysfunction, e.g. according to Child Pugh Classifica-tion class B and C, or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gall-stones, liver metastases or stable chronic non-viral liver disease per investigator assessment).
- •Concurrent disease or condition that might interfere with adequate assessment or evaluation of study data, or any medical disorder that would make the patient's participation unreasonably hazardous.
- •Other malignant diseases within the last 3 years (apart from carcinoma in situ of the cervix or non-melanoma skin cancer)
- •Dementia, altered mental status, or any psychiatric or social condition which would prohibit the understanding or rendering of informed consent or which might interfere with the patient's adherence to the protocol.
- •Life expectancy < 3 months.
- •Male gender.
- •For Everolimus/Ribociclib only:
- •Known hypersensitivity to any of the excipients of ribociclib, everolimus or any of the other given drugs.
- •Known hypersensitivity to lecithin (soya) and pea-nuts (ribocilib-cohort)
- •Disease or condition, which might restrain the ability to take or resorb oral medication. This includes malabsorption syndrome, requirement for intrave-nous (IV) alimentation, prior surgical procedures af-fecting absorption (for example resection of small bowel or stomach), uncontrolled inflammatory GI disease (e.g., Crohn's disease, ulcerative colitis) and any other diseases significantly affecting gas-trointestinal function as well as inability to swallow and retain oral medication for any other reason.
- •For Eribulin only:
- •History of hypersensitivity reactions attributed to eribulin.
- •Pre-existing neuropathy grade 3 or higher.
- •Severe Congenital long QT syndrome.
- •Pregnancy or nursing.
研究组 & 干预措施
Ribociclib in combination with standard endocrine therapy
Experimental
Postmenopausal female patients with hormone-receptor positive, HER2-negative metastatic breast cancer with HER2-negative circulating tumor cells (CTCs) and indication for standard endocrine therapy.
干预措施: Ribociclib (Drug)
Eriubulin
Experimental
Patients with hormone-receptor positive, HER2-negative metastatic breast cancer and indication to chemother-apy or patients with triple-negative metastatic breast cancer, both with HER2-negative circulating tumor cells (CTCs).
干预措施: Eribulin (Drug)
结局指标
主要结局
Progression free survival (PFS)
时间窗: 8-12 weeks
Time interval from randomization until progressive disease (PD) or death from any cause, whichever comes first
次要结局
- Overall response rate(8-12 weeks)
- Disease control rate (DCR)(8-12 weeks)
- Overall survival (OS)(4 weeks)
- For Everolimus/Ribociclib cohort only: Change in the activation of the PI3K/Akt/mTOR-pathway in CTCs(8-12 weeks)
- Dynamic of CTCs(8-12 weeks)
- For Everolimus/Ribociclib cohort only: Levels of pS6(8-12 weeks)
- For Everolimus/Ribociclib cohort only: Estrogen-receptor 1 (ESR-1) mutations in CTCs(8-12 weeks)
- For Eribulin cohort only: New metastasis-free survival (nMFS)(8-12 weeks)
研究者
Prof. Wolfgang Janni
University hospital Ulm - Department of Gynecology
University of Ulm
研究点 (1)
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