EUCTR2018-002998-21-FR进行中（未招募）1 期
A phase III, multicenter, randomized, open-label trial toevaluate efficacy and safety of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, early breast cancer (New Adjuvant TriAl with Ribociclib [LEE011]: NATALEE)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 4,000
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
- All
入选标准
- •- Patient is = 18 years-old at the time of PICF
- •- Patient is female with known menopausal status at the time of PICF signature or initiation of adjuvant ET (whichever occurs earlier), or male.
- •- 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 has breast cancer that is positive for ER
- •- Patient has HER2-negative breast cancer
- •- Patient has available archival tumor tissue from
- •the surgical specimen
- •- Patient after surgical resection where tumor was
- •removed completely, with the final surgical specimen microscopic margins free from tumor, and who belongs to one of the following categories (anatomic stage group II or III)
- •- If indicated, patient has completed adjuvant
- •and/or neoadjuvant chemotherapy according to the
- •institutional guidelines
- •- If indicated, patient has completed adjuvant
- •radiotherapy according to the institutional guidelines
- •- Patient has no contraindication for the adjuvant
- •ET in the trial and is planned to be treated with ET for 5 years
- •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 2000
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2000
排除标准
- •- Patient has received any CDK4/6 inhibitor
- •- Patient has received prior treatment with
- •tamoxifen, raloxifene or AIs for reduction in risk
- •(chemoprevention”) of breast cancer and/or
- •treatment for osteoporosis within the last 2 years prior to PICF signature
- •- 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.
- •- Patient with a known hypersensitivity to any of
- •the excipients of ribociclib and/or ET
- •- 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.
- •- Patient is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET
- •- Patient has had major surgery, chemotherapy or
- •radiotherapy within 14 days prior to randomization
- •- Patient has not recovered from clinical and
- •laboratory acute toxicities related to prior anti-cancer therapies
- •- Patient has a concurrent invasive malignancy or
- •a prior invasive malignancy whose treatment was
- •completed within 2 years before PICF signature
- •- Patient has known HIV infection, Hepatitis B or C
- •- Clinically significant, uncontrolled heart disease
- •and/or cardiac repolarization abnormality
- •- Patient:
- •- is currently receiving any of the following substances within 7 days before randomization - Concomitant
- •medications, herbal supplements, and/or
- •fruits that are known as strong inhibitors or inducers of
- •CYP3A4/5 or Medications that have a narrow
- •therapeutic window and are predominantly
- •metabolized through CYP3A4/5
- •- is currently receiving or has received systemic
- •corticosteroids = 2 weeks prior to starting trial
- •- Patient has impairment of GI function or GI disease
- •that may significantly alter the absorption of the oral
- •trial treatments
- •- Patient has any other concurrent severe and/or
- •uncontrolled medical condition that would, in the
- •Investigator’s judgment, cause unacceptable safety
- •risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol
- •- Patient participated in another interventional study
- •and received treatment with an investigational product (or used an investigational device) within 30 days prior to randomization or within 5 half-lives of the investigational product, whichever is longer.
- •- Pregnant or breast-feeding (lactating) women or
- •women who plan to become pregnant or breast-feed during the trial.
- •additional exclusion criteria as per full protocol may apply.
研究者
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