NCT02008734已完成2 期
Randomized Short-term Pre-surgical Study to Assess the Effects of PD 0332991 in Early Breast Cancer Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Anti proliferative response
研究概览
简要总结
This is a Phase II study trying to identify whether short term treatment with PD0332991 yields anti-proliferative response -defined by a low level of Ki67 expression (IHC) at surgery- or induces senescence as determined by SABG expression (IHC) in tumors from patients with early breast cancer non-candidates for neoadjuvant hormonotherapy or chemotherapy, as compared to no treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Signed written informed consent
- •Female patients aged 18 years or older.
- •Histologically or cytologically confirmed untreated invasive carcinoma of the breast irrespective of HER2 and ER status
- •No personal history of breast cancer within the last 5 years
- •Candidates for initial breast surgery, with a minimum size of 15 mm measured by breast US. Bilateral and multifocal tumors are allowed, assuming tumor evaluations and pre- and post-treatment biopsies are performed in the same target lesion.
- •High proliferative tumor as defined by either Grade 3 or Ki67 ≥20%
- •No evidence of metastatic disease.
- •Eastern Cooperative Oncology Group (ECOG) performance status 0/
- •Left ventricular ejection fraction (LVEF) of at least 50%
- •Negative pregnancy test in women of childbearing potential within 14 days prior to treatment initiation (premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization).
- •For women of childbearing potential who are sexually active, agreement to use a highly effective, non-hormonal form of contraception or two effective forms of non-hormonal contraception during and for at least 6 months post-treatment.
- •Patients must be affiliated to a social security system
排除标准
- •Patients non-candidate for upfront breast surgery or candidate for neoadjuvant chemotherapy or hormonotherapy.
- •Patients with previously treated breast cancer during the last 5 years or receiving another concomitant anticancer treatment like chemotherapy, immunotherapy, endocrine
- •Known hypersensibility to PD0332991 or any of its components.
- •Difficulty to swallow oral medication
- •Serious uncontrolled concomitant disease that would put the patient at high risk for treatment-related complications.
- •Patient whose general clinical condition does not consider postponing surgery
- •Inadequate organ function, evidenced by the following laboratory results:
- •Absolute neutrophil count <1,500 cells/mm3
- •Platelet count <100,000 cells/mm3
- •Hemoglobin <9 g/dL
- •Total bilirubin greater than 1,5 times the upper limit of normal (ULN) (unless the patient has documented Gilbert's syndrome)
- •Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) >2.5 x ULN
- •Serum creatinine >2.0 mg/dL and/or 177 μmol/L clearance creatinine <50mL/min (calculated by Cockcroft-Gault method)
- •International normalized ratio (INR) and activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT) >1.5 x ULN (unless on therapeutic coagulation)
- •Uncontrolled hypertension (systolic >150 mmHg and/or diastolic > 100 mmHg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication; unstable angina; CHF of New York Heart Association (NYHA) Grade II or higher; or serious cardiac arrhythmia requiring medication.
- •Patients with a history of long-QT syndrome or documented family history of long-QT syndrome.
- •serum potassium level < LLN
- •Uncontrolled intercurrent illness including but not limited to, known active infection with human immunodeficiency virus (HIV), hepatitis B or C virus or psychiatric illness/social situations that would limit compliance with study requirements.
- •Assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
- •Pregnant or breastfeeding patients
研究组 & 干预措施
PD0332991
Experimental
Patients will be randomized 3:1 to be treated with PD0332991 125mg/day orally for a total duration of 14 days (or 100 mg/day for a total duration of 21 days depending on results of interim analysis) with last treatment taken the day previous to the surgical procedure.
干预措施: PD0332991 (Drug)
结局指标
主要结局
Anti proliferative response
时间窗: Assessed at Day 15 after randomization
percentage of patients who at Day 15 have a natural logarithm of percentage positive IHC staining Ki67 of \<1 for each study drug (Ki67 "absolute" antiproliferative responders).
次要结局
- Dose Limiting Toxicity(Assessed at Day 8 and 15 after randomization)
- Ki67(Assessed at Day15 after randomization)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Low-dose Temozolomide for 2 Weeks on Brain Tumor Enzyme in Patients With Gliomas (P04602 AM1) (Completed)GliomaNCT00424554Merck Sharp & Dohme LLC40
招募中
2 期
Short Course Radiotherapy With Sequential Disitamab Vedotin Combined With S-1 and Sintilimab as Whole Course Neoadjuvant Therapy for HER2 Expressed Locally Progressive Gastric CancerGastric CancerNCT06487429Wuhan Union Hospital, China28
Unknown
不适用
p53 and Response to Preoperative Radiotherapy for T2 and T3Rectal CancerNCT02140723Medical University of Vienna60
进行中（未招募）
3 期
Short-course Versus Long-course Pre-operative Chemotherapy With mFOLFIRINOX or PAXG (CASSANDRA TRIAL)Pancreas Ductal AdenocarcinomaNCT04793932Associazione Italiana per lo Studio del Pancreas261
已完成
2 期
A Trial to Assess the Activity and Safety of Palbociclib in Patients With Well and Moderately Differentiated Metastatic Pancreatic Neuroendocrine Tumors (pNET)Pancreatic Neuroendocrine CancerNCT02806648Grupo Espanol de Tumores Neuroendocrinos21