EUCTR2019-002015-26-ES进行中（未招募）1 期
Phase 2 window study of two dose levels of SAR439859 (SERD) versus letrozole in newly diagnosed preoperative post-menopausal patients with ER positive, HER2 negative primary breast cancer
SANOFI-AVENTIS RECHERCHE & DEVELOPPEMENT0 个研究点目标入组 105 人开始时间: 2019年11月6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
- 105
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
- Female
入选标准
- •-Histological or cytological proven diagnosis of invasive breast adenocarcinoma
- •-Localized breast cancer eligible for immediate breast conservative surgery: Stage II or operable Stage III (excludes T4) as defined in American Joint Committee on Cancer (AJCC) Cancer Staging Manual 8th edition 2017
- •-Postmenopausal women as defined by one of the following:
- •-Age =60 years
- •-Age <60 years with: spontaneous cessation of menses >12 months; or with cessation of menses of duration =12 months or secondary to hysterectomy and have follicle stimulating hormone (FSH) level in the postmenopausal range; or who have received hormonal replacement therapy but have discontinued this treatment and have FSH level in the postmenopausal range; or with status post bilateral surgical oophorectomy; or postbilateral ovarian ablation through pelvic radiotherapy; or are premenopausal women on a gonadotropin-releasing hormone (GnRH) analog for at least 4 weeks (to be continued during study treatment)
- •-Breast tumor size of at least 10 mm in short axis measured by ultrasound
- •-Primary tumor must be positive for Estrogen Receptors (ER+) and negative for HER2 (HER2-) receptor by immunohistochemistry
- •-Ki67 level of at least 15% at diagnosis from immunohistochemistry of the tumor
- •-Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- •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 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 60
排除标准
- •Medical history or ongoing gastrointestinal disorders potentially affecting the absorption of SAR439859 or letrozole; Participants unable to swallow normally and to take capsules or tablets
- •-Participant with any other cancer; adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer or any other cancer from which the participant has been disease free for >3 years are allowed
- •-Evidence of metastatic spread by standard assessment according to local practice
- •-Treatment with strong or moderate Cytochrome P450 3A (CYP3A) or CYP2C8 inducers within 2 weeks before first study treatment administration or 5 elimination half-lives whichever is longest
- •-Ongoing treatment with drugs that are sensitive substrates of P-glycoprotein (P-gp)
- •-Use of any investigational agent within 4 weeks prior to randomization
- •-Currently receiving (and unwilling to discontinue) hormone replacement therapy (last dose <14 days prior to randomization)
- •-Prior anti-cancer treatment is not allowed unless it was completed at least 1 year prior to inclusion into this trial
- •-Previous systemic or local treatment for the new primary breast cancer currently under investigation (including surgery, radiotherapy, cytotoxic and endocrine treatments)
- •-Inadequate hematological or renal function
- •-Prothrombin time/international normalized ratio (INR) >1.5 x ULN) or outside therapeutic range if receiving anticoagulation that would affect the prothrombin time/INR
- •-Any of the following abnormal liver function test results: Aspartate aminotransferase >1.5 x upper limit of normal (ULN); Alanine aminotransferase >1.5 x ULN; Total bilirubin >1.5 x ULN
- •-Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals
- •-Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
研究者
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