EUCTR2018-002998-21-IT进行中（未招募）1 期
A phase III, multicenter, randomized, open-label trial to evaluate 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) - NATALEE
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
- •Patients eligible for inclusion in this trial must meet all of the following criteria:
- •1. Signed and dated Patient Informed Consent Form (PICF) obtained prior to any trial-specific screening procedure.
- •2. Patient is = or >18 years-old at the time of PICF signature.
- •3. Patient is female with known menopausal status at the time of randomization or initiation of adjuvant ET (whichever occurs earlier), or male.
- •4. Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis (i.e. date of the pathology report that
- •confirmed the BC diagnosis)within 18 months prior to randomization.
- •5. Patient has breast cancer that is positive for ER and/or PgR.
- •6. Patient has HER2-negative breast cancer.
- •7. Patient has available archival tumor tissue from the surgical specimen.
- •8. 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 Group III
- •9. If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines, prior to screening.
- •10. If indicated, patient has completed adjuvant radiotherapy according to the institutional guidelines, prior to screening.
- •11. 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
- •1. Patient has received any CDK4/6 inhibitor.
- •2. 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 randomization.Patient is concurrently using hormone replacement therapy.
- •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 ET (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.
- •6. Patient is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET (see Inclusion Criterion #12).
- •7. Patient has had major surgery, chemotherapy or radiotherapy within 14 days prior to randomization.
- •8. Patient has not recovered from clinical and laboratory acute toxicities related to prior anti-cancer therapies to a NCI CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) version 4.03 Grade > or =1 at day of randomization. Exception to this criterion: patients with any grade of alopecia and amenorrhea are allowed to enter the trial.
- •9. Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before randomization. Note: Patients with prior or concurrent in situ malignancies are eligible provided that adequate curative treatment is completed prior to randomization.
- •10. Patient has known history of human immunodeficiency virus (HIV) infection.
- •11. Patient has known active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- •12. Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
- •13. Patient that 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
- •14. Patient that is currently receiving or has received systemic corticosteroids = 2 weeks prior to starting trial treatment
- •15. Patient has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments
- •16. 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
- •17. Participation in other studies involving interventional drug(s) within 30 days prior to randomization or within 5 half-lives of the investigational drug(s), whichever is longer or participation in any other type of medical research judged not to be scientifically or medically compatible with this trial. If the patient is enrolled or planned to be enrolled in another study that does not involve an investigational drug, the agreement of the Medical Monitor is required to establish eligibility.
- •18. Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during th
研究者
相似试验
进行中（未招募）
1 期
A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib withendocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancerhormone receptor-positive, HER2-negative, early breast cancerMedDRA version: 20.0Level: LLTClassification code 10006203Term: Breast cancer stage unspecifiedSystem Organ Class: 100000004864MedDRA version: 20.1Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864EUCTR2018-002998-21-FRovartis Pharma AG4,000
进行中（未招募）
1 期
A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib withendocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancerhormone receptor-positive, HER2-negative, early breast cancerMedDRA version: 20.0Level: LLTClassification code 10006203Term: Breast cancer stage unspecifiedSystem Organ Class: 100000004864MedDRA version: 23.0Level: LLTClassification code 10070575Term: Estrogen receptor positive breast cancerSystem Organ Class: 100000004864EUCTR2018-002998-21-BEovartis Pharma AG5,000
招募中
1 期
Regorafenib-pembrolizumab vs. TACE/TARE in intermediate-stage HCC beyond up-to-7.Intermediate-stage hepatocellular carcinoma with beyond up-to-7 criteria.MedDRA version: 21.1Level: LLTClassification code: 10049010Term: Carcinoma hepatocellular Class: 10029104CTIS2022-501969-42-00Translational Research In Oncology597
招募中
Unknown
Regorafenib-pembrolizumab vs. TACE/TARE in intermediatestage HCC beyond up-to-7 (REPLACE)Diseases of the digestive systemKCT0009093Inje University Haeundae Paik Hospital496
招募中
3 期
A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer2023-510357-42-00Novartis Pharma AG2,394