EUCTR2014-004698-17-CZ进行中（未招募）1 期
A randomized, multicenter, open-label, phase II trial to evaluate the efficacy and safety of palbociclib in combination with fulvestrant or letrozole in patients with HER2 negative, ER+ metastatic breast cancer. - PARSIFAL 1
Medica Scientia Innovation Research (MedSIR)0 个研究点目标入组 486 人开始时间: 2015年9月10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
- 486
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. Postmenopausal women, as defined by any of the following criteria:
- •- Age 60 or over
- •- Age 45 to 59 years and meets = 1 of the following criteria:
- •- Amenorrhea for = 24 months
- •- Amenorrhea for < 24 months and follicle-stimulating hormone within
- •the postmenopausal range (including patients with hysterectomy, prior
- •hormone replacement therapy, or chemotherapy-induced amenorrhea)
- •- Over 18 years of age and bilateral oophorectomy
- •2. Eastern Cooperative Oncology Group (ECOG) score lower or equal to 2
- •3. Histologically confirmed recurrent ER positive (oestrogen and/or progesterone) HER2-negative locally advanced or metastatic BC patients. Patients are not eligible if they are candidates for a local treatment with a radical intention.
- •4. No prior chemotherapy line in the metastatic setting
- •5. Patient must have measurable (according to RECIST 1.1) or non measurable disease with these exceptions
- •- Patients with only blastic bone lesions are not eligible
- •- Patients with only pleural, peritoneal or cardiac effusion, or meningeal
- •carcinomatosis are not eligible
- •6. Life expectancy grater or equal to 12 weeks
- •7. Adequate organ function:
- •- Hematological: White blood cell (WBC) count >3.0 x 109/L, absolute neutrophil count (ANC) >1.0 x 109/L, platelet count >75.0 x109/L, and hemoglobin >10.0 g/dL (>6.2 mmol/L)
- •- Hepatic: bilirubin < 1.5 times the upper limit of normal (x ULN); alkaline phosphatase (ALP), aspartate transaminase (AST), and alanine transaminase (ALT) <2.5 times ULN
- •- Renal: serum creatinine < 1.5 x ULN.
- •8. Exhibit patient compliance and geographic proximity that allow for adequate follow-up.
- •9. Patient has been informed about the nature of study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.
- •10. No other malignancies within the past five years except adequate treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
- •11. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCICTCAE version 4.0 Grade =1 (except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion).
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 104
排除标准
- •Patients will be excluded from the study if they meet ANY of the following criteria:
- •1. ER or HER2 unknown disease
- •2. HER2 positive disease based on local laboratory results (performed by immunohistochemistry/FISH)
- •3. Locally advanced breast cancer candidate for a radical treatment.
- •4. Prior endocrine therapy in the metastatic setting. (Neo)/Adjuvant endocrine therapy is allowed only if the disease-free interval between the end of endocrine therapy and the appearance of metastases in higher than 12 months.
- •5. Patients with rapidly progressive visceral disease or visceral crisis.
- •6. Have had a major surgery (defined as requiring general anaesthesia) or significant traumatic injury within 4 weeks of start of study drug, patients who have not recovered from the side effects of any major surgery or patients that may require major surgery during the course of the study.
- •7. Patients with an active, bleeding diathesis.
- •8. Have a serious concomitant systemic disorder (e.g. active infection including HIV, or cardiac disease) incompatible with the study (at the discretion of investigator), previous history of bleeding diathesis, or anti-coagulation treatment (The use of low molecular weight heparin is allowed as soon as it is used as prophylaxis intention).
- •9. Are unable to swallow tablets.
- •10. History of malabsorption syndrome or other condition that would interfere with enteral absorption.
- •11. Chronic daily treatment with corticosteroids with a dose of = 10mg/day methylprednisolone equivalent (excluding inhaled steroids).
- •12. Known active uncontrolled or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease as indicated by clinical symptoms, cerebral oedema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have been definitively treated with local therapy (e.g., radiotherapy, stereotactic surgery) and are clinically stable off anticonvulsants and steroids for at least 4weeks before randomization
- •13. Known hypersensitivity to letrozole, fulvestrant or any of their excipients, or to any PD-0332991 excipients.
- •14. QTc >480 msec on basal assessments, personal history of long or short QT syndrome, Brugada syndrome or known history of QTc prolongation, or Torsade de Pointes (TdP).
- •15. Uncontrolled electrolyte disorders that can compound the effects of a QTc-prolonging drug (e.g., hypocalcemia, hypokalemia, hypomagnesemia).
研究者
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