2025-522484-15-00招募中3 期
Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing adjuvant Elacestrant with standard endocrine treatment in genomically and/or clinically high-risk ER+/HER2- early breast cancer (ADAPTela)
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,520
- 试验地点
- 115
- 主要终点
- iDFS, compared between patients randomized to adjuvant elacestrant (+/-CDK4/6i) or SOC ET (+/- CDK4/6i)
研究概览
简要总结
To show efficacy in terms of improved survival (iDFS) in patients receiving adjuvant elacestrant-containing therapy (+/- CDK4/6i) compared to SoC (+/- CDK4/6i) only
研究设计
- 分配方式
- Na
- 主要目的
- Follow-up phase
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •All patients, independent from gender
- •Completed 2-6 weeks of endocrine induction treatment and Ki-67 response assessment Note: 2-4 weeks recommended, up to 6 weeks allowed. Endocrine induction is highly recommended, but if endocrine induction therapy could not be performed or ET response is not representative, clinical factors should be used.
- •Completed (neo)adjuvant chemotherapy, if applicable
- •Completed radiotherapy, if applicable
- •Patient meets any of the following three conditions at end of primary treatment (including endocrine induction treatment, biopsy/surgery, and if necessary, chemotherapy and radiotherapy and up to 12 months standard- of-care endocrine treatment, excluding previous treatment > 4 weeks with any SERD): see protocol for details
- •No contraindication for adjuvant SoC endocrine treatment
- •No contraindication for elacestrant treatment
- •No contraindication for ribociclib treatment, if medically indicated, and adequate washout time for CYP3A4 inducers/inhibitors or QT time- prolonging drugs
- •Tumour block available for central pathology review (core biopsy of initial diagnosis and biopsy/surgery sample of definite surgery, if available)
- •Performance Status ECOG ≤ 1 or Karnofsky Index ≥ 80%
- •Laboratory requirements (female and male patients, not older than 14 days prior to date of informed consent): absolute neutrophil count ≥ 1.5 × 109/L, platelets ≥ 100 × 109/L, haemoglobin ≥ 9.0 g/dL, INR ≤ 1.5, serum creatinine < 1.5 × ULN OR clearance ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN, total bilirubin < ULN, except for patients with Gilbert’s Syndrome who may only be included if the total bilirubin is ≤ 3.0 × ULN or direct bilirubin ≤ 1.5 × ULN, aspartate transaminase (AST) < 2.5 × ULN, alanine transaminase (ALT) < 2.5 × ULN, Screening lipid panel fasting levels: total cholesterol ≤400 mg/dL AND/OR triglycerides <500 mg/dL.
- •Patient must be ≥18 years at diagnosis
- •Clinical assessments: normal electrocardiogram within 6 weeks prior to randomization (QTcF interval at screening <450msec using Fridericia’s correction, mean resting heart rate 50-90 bpm)
- •Ability to swallow tablets
- •Contraception: see protocol for details
- •The patient must be capable of giving informed consent and be willing and able to comply with the requirements and restrictions in this protocol and accessible for treatment and follow-up
- •Sign informed consent prior to any study-specific procedures.
- •Histologically confirmed unilateral, primary invasive carcinoma of the breast. Note: bilateral, multicentric, or multifocal carcinoma may only be included after consultation of Sponsor.
- •Histologically confirmed diagnosis of primary hormone-receptor-positive (HR+) (i.e., oestrogen-receptor (ER) ≥ 10% and/or progesterone-receptor PR ≥ 10%) early breast cancer by local laboratory Note: ER positive according to ASCO / AGO Guidelines, ER 1-10% (low) is not defined as HR+.
- •Patient has HER2-negative breast cancer defined as a negative in-situ hybridization test or an IHC status of 0, 1+, or 2+, if IHC is 2+, a negative in-situ hybridization (FISH, CISH, or SISH) test is required (based on the most recently analysed tissue sample and all tested by a local laboratory).
- •No evidence of distant metastasis (confirmed by CT thorax / abdomen, X- ray chest, ultrasound liver, bone scan, or PET-CT, respectively, performed within clinical routine).
- •High genomic risk assessment within clinical routine (Oncotype DX® preferred; In those cases, where Oncotype Dx® is not possible in clinical routine, Oncotype Dx® should be assessed retrospectively after inclusion of the patient and as a study specific measure, provided sufficient tumour tissue from primary diagnosis is available.)
排除标准
- •Known hypersensitivity to any of the compounds or incorporated substances of the IMPs
- •Breast feeding woman
- •Use of oral, transdermal, injected, or implanted hormonal methods of contraception as well as hormonal replacement therapy (oestrogen or progesterone).
- •Reasons indicating risk of poor compliance
- •Patient not able to consent
- •Patient has not recovered from clinical and laboratory acute toxicities related to prior anticancer therapies to NCI CTCAE version 5.0 Grade ≤
- •Severe and relevant co-morbidity that would interact with the application of endocrine treatment of any kind or the participation in the study
- •For patients planned for ribociclib treatment: Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, including any of the following: see protocol for details
- •Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhoea, malabsorption syndrome, or small-bowel resection).
- •Uncontrolled infection requiring i.v. antibiotics, antivirals, or antifungals
- •Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection. Patients should be tested for HIV prior to randomization if required by local regulations or ethics committee (EC). Patients who test positive for HIV-antibody are excluded.
- •Prior malignancy with a disease-free survival of <5 years, except curatively treated basalioma of the skin or pTis of the cervix uteri
- •Patient has known active hepatitis-B-virus (HBV) or hepatitis-C-virus (HCV) infection. Screening for HBV or HBC-infection and testing for hepatitis-B or -C is highly recommended according to current valid (local) clinical guidelines, but neither part of the interventional study procedures, nor required for enrolment.
- •Patient has received live vaccines within 30 days prior to randomization.
- •Patient was submitted to an institution by virtue of an order of a court or a governmental authority must be excluded from participation.
- •Any history of invasive cancer within the last 10 years Note: adequately treated, basal or squamous-cell skin carcinoma, non- melanomatous skin cancer, curatively resected cervical cancer, and contralateral DCIS treated by mastectomy (contralateral in relation to current invasive breast cancer diagnosis) are excepted. Previous ipsilateral DCIS, irrespective of treatment, is excluded!
- •Patient with distant metastases of breast cancer beyond regional lymph nodes.
- •Concurrent treatment with cytotoxic agents for any non-oncological reason unless clarified with sponsor
- •Concurrent treatment with other experimental drugs
- •Participation in another interventional clinical trial with or without any investigational, not marketed drug within 30 days or 5 half-lives of the respective drug, whichever is longer, prior to study entry. In case of other interventional trial contact Sponsor.
- •Previous treatment (>4 weeks) with any SERD
- •Concurrent pregnancy; patients of childbearing potential or potentially childbearing partners of male patients must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
研究组 & 干预措施
ORSERDU 86 mg film-coated tablets, ORSERDU 345 mg film-coated tablets
Test
干预措施: ORSERDU 345 mg film-coated tablets (Drug)
Kisqali 200 mg film-coated tablets, Kisqali 200 mg film-coated tablets, Kisqali 200 mg film-coated tablets, Kisqali 200 mg film-coated tablets
Test
干预措施: Kisqali 200 mg film-coated tablets (Drug)
ORSERDU 86 mg film-coated tablets, ORSERDU 345 mg film-coated tablets
Test
干预措施: ORSERDU 86 mg film-coated tablets (Drug)
结局指标
主要结局
iDFS, compared between patients randomized to adjuvant elacestrant (+/-CDK4/6i) or SOC ET (+/- CDK4/6i)
iDFS, compared between patients randomized to adjuvant elacestrant (+/-CDK4/6i) or SOC ET (+/- CDK4/6i)
次要结局
- dDFS
- RFS
- DFS-DCIS
- IBCFS
- OS defined as time from first diagnosis to death
- LRFS, each as defined in STEEP 2.0
- Change of HRQoL between baseline, measured after completion of SoC primary treatment (including (neo)adjuvant chemotherapy, surgery, further local therapy), and on following defined timepoints: before start of treatment, 6-monthly during treatment until year 3 and yearly afterwards.
- Long-term survival endpoints
- Survival outcomes in premenopausal patients with N0 + RS 16-25 and N1 + RS 0-25 treated by ovarian function suppression (OFS) in combination with either aromatase inhibitor or tamoxifen (SoC) +/- ribociclib (in stage II) or elacestrant +/- ribociclib (in stage II) without chemotherapy use
- Comparison of toxicity of regimen by evaluation of adverse events of special interest (AESI)-, adverse drug reaction (ADR)-, serious adverse drug reaction (SADR)-, and serious adverse event (SAE)-rates.
研究者
Medical Board
Scientific
WSG Women's Cancer Study Group GmbH
研究点 (115)
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