Neoadjuvant Endocrine Therapy in Breast Cancer. Real Clinical Practice in Russia
概览
- 阶段
- 不适用
- 干预措施
- Tamoxifen 20mg
- 疾病 / 适应症
- Breast Cancer
- 发起方
- Blokhin's Russian Cancer Research Center
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- the number of patients with a Residual Cancer Burden (RCB) 0-I index as a measure of efficacy
- 状态
- 招募中
- 最后更新
- 3年前
概览
简要总结
Neoadjuvant Endocrine Therapy for pre- and postmenopausal women with T4 Nany or TanyN2-3 estrogen receptor (ER) -positive, progrsteron receptor (PR) -positive and HER2 negative breast cancer. Real Clinical Practice in Russia.
详细描述
Neoadjuvant Endocrine Therapy for pre- and postmenopausal women with T4 Nany or TanyN2-3 estrogen receptor (ER) -positive, progrsteron receptor (PR) -positive and HER2 negative breast cancer. Real Clinical Practice in Russia. Nonrandomized, retrospective clincal trial Eligible postmenopausal women were treated with tamoxifen 20 mg, exemestane 25 mg daily, letrozole 2.5 mg daily, or anastrozole 1 mg daily before surgery or Eligible premenopausal women were treated with tamoxifen 20 mg, exemestane 25 mg daily, letrozole 2.5 mg daily, or anastrozole 1 mg daily in combination with ovarian suppression before surgery
研究者
入排标准
入选标准
- •Histologically confirmed of hormone receptor-positive (HR +), human epidermal growth factor receptor 2-negative (HER2-) invasive breast cancer T4 Nany or Tany N2-N3 premenopausal or menopausal women aged 18 years or older. No evidence of metastasis (M0) No prior hormonal, chemotherapy or radiotherapy is allowed. No breast operation other than biopsy to make diagnosis is allowed.
- •Postmenopausal women, defined as women meeting any of the following criteria:
- •Age ≥ 60 years Age ≥ 45 years with amenorrhea ≥ 12 months in the moment of breast cancer diagnosis and an intact uterus Prior bilateral ovariectomy In case previous hysterectomy, follicle stimulating hormone (FSH) and estradiol levels within the postmenopausal range (using local laboratory ranges)\* \* In patients previously treated with a luteinizing hormone releasing hormone (LH-RH) analogue, the last extended release formulation should have been administered more than 6 months before randomisation, and menses must not have reappeared.
- •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.Eastern Cooperative Oncology Group (ECOG) performance status 0/1/2 No personal history of breast cancer within the last 5 years
排除标准
- •Patients non-candidate for breast surgery Patients with previously treated breast cancer during the last 5 years or receiving another concomitant anticancer treatment like chemotherapy, immunotherapy, endocrine 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
premenopausal women
premenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3
干预措施: Tamoxifen 20mg
premenopausal women
premenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3
干预措施: Anastrozole 1mg
premenopausal women
premenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3
干预措施: Letrozole 2.5mg
premenopausal women
premenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3
干预措施: Goserelin
premenopausal women
premenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3
干预措施: Triptorelin
postmenopausal women
postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3
干预措施: Tamoxifen 20mg
postmenopausal women
postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3
干预措施: Anastrozole 1mg
postmenopausal women
postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer T4 Nany or Tany N2-3
干预措施: Letrozole 2.5mg
结局指标
主要结局
the number of patients with a Residual Cancer Burden (RCB) 0-I index as a measure of efficacy
时间窗: Up to 5 years
Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. 6 variables are included in a calculation formula.
次要结局
- Preoperative Endocrine Prognostic Index (PEPI)(Up to 5 years)
- clinical response in each treatment arm as defined by clinical and ultrasound examination.(Up to 5 years)
- the rates of breast conservation therapy with regard to the initially planned surgery(Up to 5 years)
- Disease-free survival (DFS)(Up to 5 years)