EUCTR2019-004899-19-FR进行中（未招募）1 期
Adjuvant PalbOciclib + LetrOzole combination for hormone receptor positive / HER2-negative, Intermediate Risk breast cancer - APOLO
ICANCER0 个研究点目标入组 1,500 人开始时间: 2020年4月16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
- 1,500
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.Female, age =18 years
- •2.Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1
- •3.Histologically confirmed adenocarcinoma of the breast (bilateral breast cancer allowed)
- •4.Breast cancer tumor removed by surgery
- •5.Hormone receptor positive: ER+ and/or PR+ by IHC (=10%)
- •6.HER2-negative by IHC (score 0 or 1+) and/or DISH negative (HER2 copy number <6 and HER2/CEP17 ratio <2)
- •7.Intermediate risk breast cancer defined by pathological characteristics as follow:
- •-pT1 AND pN0* AND histological grade 3
- •-or pT1 AND pN1 AND histological grade 1 or 2
- •-or pT2 AND pN0* AND histological grade 2
- •* pN1a or pNmi reflecting the presence of micrometastases and pN0(i+) representing isolated tumour cells will be classified as pN0
- •Note: In case a genomic test has been performed and the result classifies the patient in an intermediate risk, patient is eligible independently of the pathological characteristics listed above.
- •8.No prior pre-operative or (neo)adjuvant/adjuvant chemotherapy, targeted therapy or endocrine therapy. Short term, window of opportunity preoperative therapy, will be allowed provided cancer biology is assessed on the primary biopsy.
- •9.Postmenopausal women, as defined by any of the following criteria:
- •-Prior bilateral oophorectomy
- •-Age =60 years
- •-Age <60 years and amenorrheic for 12 or more months in the absence of chemotherapy, tamoxifen, toremifene, or ovarian suppression and FSH and estradiol in the postmenopausal range
- •10.Adequate renal, hepatic, and hematopoietic functions as defined by the following criteria:
- •-Absolute Neutrophil Count (ANC) =1,500/mm3 or =1.5 x 109/L
- •-Platelets =100,000/mm3 or =100 x 109/L
- •-Hemoglobin =9 g/dL
- •-Serum Aspartate Transaminase (AST) and serum Alanine Aminotransferase Transaminase (ALT) =2.5 x upper limit of normal (ULN) (4x if liver metastasis)
- •-Alkaline phosphatase =2.5 x ULN
- •-Total serum creatinine =1.5 x ULN or estimated creatinine clearance >60 mL/min as calculated using the method standard for the institution
- •11.Adequate cardiac functions, including:
- •-12 Lead electrocardiograms (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention.
- •-QTc interval =480 msec (mean of replicate values, correction per institutional standard)
- •-No history of Torsades de Pointes or other symptomatic QTc abnormality.
- •12.Patient must be willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests and other study procedures.
- •13.Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient’s consent.
- •14.Patient must be affiliated to a Social Security System (or equivalent).
- •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 500
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1000
排除标准
- •1.pN2 or pN3 (>3 involved nodes)
- •2.pT3 or c/pT4
- •3.Metastatic disease (M1)
- •4.Multifocal tumors with >3 invasive lesions (in case of multifocal lesions up to 3, all must share the same biological profile)
- •5.Hormone Receptor or HER2 unknown disease
- •6.Prior pre-operative or (neo)/adjuvant/adjuvant chemotherapy, targeted therapy or endocrine therapy (except short term window of opportunity therapy as described in inclusion criteria)
- •7.Patients who have not recovered from the side effects of any major surgery
- •8.Inability or willingness to swallow oral medication
- •9.Previous treatment with palbociclib or any other CDK 4/6 inhibitors
- •10.Contraindications or known hypersensitivity to letrozole, palbociclib or any of their excipients
- •11.History of mal-absorption syndrome or other condition that would interfere with enteral absorption
- •12.Patients receiving any drug that is known to be potent inhibitor or inducer of CYP3A isoenzymes within the last 7 days prior to treatment start in the trial
- •13.Patients with a history of malignancy, other than invasive breast cancer, with the following exceptions:
- •-Patients diagnosed, treated and disease-free for at least 5 years and deemed by the investigator to be at low risk for recurrence of that malignancy are eligible
- •-Patients with the following malignancies are eligible, even if diagnosed and treated within the past 5 years: ductal carcinoma in situ of the breast; cervical cancer in situ; thyroid cancer in situ; non-metastatic, non-melanomatous skin cancer.
- •14.Concurrent disease or condition that would make the patient inappropriate for trial participation or any serious medical disorder that would interfere with the patient’s safety, such as:
- •-Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension (=180/110), unstable diabetes mellitus, dyspnea at rest, or chronic therapy with oxygen, etc.
- •-Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association (NYHA) Functional Classification. To be eligible for this trial, patients should be class 2B or better.
- •-Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial.
- •-For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
- •-Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
- •15.Patients with psychiatric illness/social situations that would limit adherence with study requirements.
- •16.Participation in another therapeutic trial within the 30 days prior to initiation of treatment.
- •17.Patients unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons.
- •18.Persons deprived of their liberty or under protective custody or guardianship
研究者
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