PER-016-19已完成未知
ESTUDIO DE FASE III, MULTICENTRICO, ALEATORIZADO Y ABIERTO PARA EVALUAR LA EFICACIA Y SEGURIDAD DE RIBOCICLIB CON TERAPIA ENDOCRINA COMO TRATAMIENTO ADYUVANTE EN PACIENTES CON CANCER DE MAMA EN ETAPA INICIAL HER-2 NEGATIVO CON RECEPTORES DE HORMONAS POSITIVOS (NUEVO ESTUDIO ADYUVANTE CON RIBOCICLIB [LEE011]: NATALEE)
OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 0 人开始时间: 2019年10月30日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Signed and dated Patient Informed Consent Form (PICF) obtained prior to any trial-specific screening procedure.
- •2. Patient is ≥ 18 years-old at the time of PICF signature.
- •3. Patient is female with known menopausal status at the time of PICF signature or initiation of adjuvant endocrine therapy (whichever occurs earlier), or male.
- •Postmenopausal status is defined as:
- •-Patient underwent bilateral oophorectomy, or
- •-Age ≥ 60 years, or
- •-Age < 60 years and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen or ovarian suppression) and Follicle-stimulating hormone (FSH) and plasma estradiol are in the postmenopausal ranges per local normal ranges.
- •Note: for women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol per local clinical guidelines are required for determination of postmenopausal status.
- •All women who do not meet the criteria for postmenopausal status are considered premenopausal for the purpose of this trial.
- •4. Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization. Patient with a multicentric and/or multifocal tumor is eligible if all histopathologically examined lesions meet the pathologic criteria in inclusion criteria 5 and 6.
- •5. Patient has breast cancer that is positive for estrogen receptor and/or progesterone receptor according to the local laboratory as determined on the most recently analyzed tissue sample.
- •This exclusion criteria your can in the protocol
排除标准
- •1. Patient has received any CDK4/6 inhibitor.
- •2. Patient has received prior treatment with tamoxifen, raloxifen or aromatase inhibitors for reduction in risk (chemoprevention”) of breast cancer and/or treatment for osteoporosis within the last 2 years prior to PICF signature.
- •3. Patient has received prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin.
- •4. Patient with a known hypersensitivity to any of the excipients of ribociclib and/or endocrine therapy (e.g. rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, glucose-galactose malabsorption, and soy allergy).
- •5. Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
- •This others exclusion cirterian your can find in the protocol
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