EUCTR2014-002560-33-BE进行中（未招募）1 期
Open-label, randomized, multicenter, international, parallel exploratory phase II study, comparing 3 FEC-3 Docetaxel chemotherapy to letrozole + palbociclib combination as neoadjuvant treatment of stage II-IIIA PAM 50 defined Luminal breast cancer, in postmenopausal women. - NEOPA
ICANCER0 个研究点目标入组 180 人开始时间: 2015年4月24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
- 180
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
- •1) Aged = 18 years, Post-menopausal women according to the following criteria
- •Age > 60 years,
- •Bilateral ovariectomy,
- •Age = 60, with an uterus and presenting an amenorrhea of more than 12 months,
- •Age = 60 without an uterus and FSH > 20 IU/L
- •2) Newly diagnosed and operable unilateral invasive breast cancer, not candidate or uncertain for breast conservation –
- •Note: Multicentric/multifocal tumors are allowed provided a maximum of 3 lesions are present, and all share the same characteristics: ER Allred 4, Her2- (PAM50 will be performed in the largest lesion)
- •3) Stage II-IIIA
- •4) Assessment of nodal status available (Ultrasound guided FNA or biopsy if necessary)
- •5) Non metastatic, M0
- •6) ER-positive by IHC (Allred Score=4)
- •7) HER2-negative by IHC (score 0 or 1+) and/or Fish/Cish
- •8) PAM50 (Prosigna™) centralized evaluation available and:
- •- Either Luminal A AND proven nodal involvement (cytology or histology), or Luminal B for randomized patients PAM50.
- •- Or Luminal A N- for non-randomized patients.
- •9) ECOG 0-1
- •10) No prior systemic therapy for the present tumor
- •11) Adequate renal, hepatic, and hematopoietic functions as defined by the following criteria:
- •o Absolute Neutrophil Count (ANC) =1,500/mm3 or =1.5 x 10^9/L
- •o Platelets =100,000/mm3 or =100 x 10^9/L
- •o Hemoglobin =9 g/dL
- •o Serum Aspartate Transaminase (AST) and serum Alanine Aminotransferase Transaminase (ALT) =2.5 x upper limit of normal (ULN)
- •o Alkaline phosphatase =2.5 x ULN
- •o Total serum bilirubin =1 x ULN
- •o Serum creatinine =1.5 x ULN or estimated creatinine clearance = 60 mL/min as calculated using the method standard for the institution
- •12) Adequate cardiac functions, including:
- •o 12 Lead electrocardiogram (ECG) with normal tracing or non clinically significant changes that do not require medical intervention.
- •o QTc interval =480 msec
- •o No history of Torsades de Pointes or other symptomatic QTc abnormality.
- •13) Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
- •14) Signed informed consent and health insurance coverage
- •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 60
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1) Non operable, bilateral, T4 or metastatic breast cancer
- •2) Limited T2 breast cancer immediately accessible to conservative surgery
- •3) Previous homolateral breast cancer (including in situ carcinoma), and/or contralateral breast cancer except if treated by surgery +/- radiation therapy alone without any systemic treatment
- •4) Previous hormone replacement therapy (HRT) stopped less than 2 weeks before beginning of treatment
- •5) Previous use of SERMs such as raloxifene
- •6) Any surgery (not including minor procedures such as lymph node biopsy, primary tumor core biopsy, fine needle aspiration) within 4 weeks of start of study treatment; or not fully recovered from any side effects of previous procedures.
- •7) Diagnosis of any previous malignancy within the last 5 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma
- •8) Diagnosis of hypokalemia
- •9)History of any previous anti-cancer chemotherapy and any previous treatment using AI
- •10) Concurrent administration of herbal preparations as complementary medicine.
- •11) Any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drugs, such as the inability to take oral medication in tablet form and malabsorption syndrome
- •12) Patient with any psychological, familial, social or geographical condition which could potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
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