EUCTR2020-004637-20-DK进行中（未招募）1 期
A Phase Ib/III Randomised Study of Capivasertib plus CDK4/6i and Fulvestrant versus Placebo plus CDK4/6 Inhibitors and Fulvestrant in Hormone Receptor-Positive and Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced, Unresectable or Metastatic Breast Cancer (CAPItello-292) - CAPItello-292
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 5
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
- •Key inclusion criteria for both phases:
- •1. Adult females (pre- and/or post-menopausal), and adult males.
- •2. Histologically confirmed HR+/ HER2- breast cancer determined from
- •the most recent tumour sample (primary or metastatic) per the
- •American Society of Clinical Oncology and College of American
- •Pathologists guideline. To fulfil the requirement of HR+ disease, a breast
- •cancer must express ER with or without co-expression of progesterone
- •3. Adequate organ and bone marrow functions.
- •4. Consent to provide a mandatory FFPE tumour sample.
- •Inclusion criteria only for phase I:
- •1. Eligible for fulvestrant therapy and at least one of the following:
- •palbociclib, ribociclib, or abemaciclib, as per local investigator
- •assessment.
- •Inclusion criteria only for phase III:
- •1. Radiologic measurable relapse during neoadjuvant / adjuvant
- •endocrine therapy or evidence of relapse within 12 months of completion
- •of adjuvant therapy or disease progression during the initial 12 months
- •of 1L endocrine therapy in locally advanced unresectable or metastatic
- •breast cancer.
- •2. Received up to a maximum of 1 lines of prior chemotherapy in the
- •advanced/metastatic setting without progression during the
- •chemotherapy planned course.
- •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 638
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 212
排除标准
- •Key exclusion criteria for both phases:
- •1. History of another primary malignancy except for malignancy treated
- •with curative intent with no known active disease = 5 years before the
- •first dose of study intervention and of low potential risk for recurrence.
- •2. Radiotherapy within 2 weeks prior to study treatment initiation.
- •3. Major surgical procedure within 4 weeks of the first dose of study
- •4. Persistent toxicities (>CTCAE Grade 1) caused by previous anti-cancer
- •therapy, excluding alopecia. Participants with irreversible toxicity
- •expected to be exacerbated by study intervention may be included (eg,
- •hearing loss or peripheral sensory neuropathy) after consultation with
- •the AstraZeneca study physician.
- •5. Spinal cord compression, brain metastases or leptomeningeal
- •metastases unless these lesions were treated and confirmed stable,
- •asymptomatic and not requiring steroids for the management of the
- •symptoms within 4 weeks prior to study treatment initiation.
- •6. Any of the following cardiac criteria at screening:
- •(a). Mean resting corrected QT interval (QTcF): Abemaciclib and
- •palbociclib arms: QTcF = 470 msec obtained from the average of 3
- •consecutive (triplicate) ECGs
- •Ribociclib arm: QTcF = 450 msec obtained from the average of 3
- •consecutive (triplicate) ECGs
- •(b). Any clinically important abnormalities in rhythm, conduction or
- •morphology of ECG (eg, complete left bundle branch block, second or
- •third-degree AV block)
- •(c). Any factors that increase the risk of QTc prolongation or risk of
- •arrhythmic events
- •(d). Experience of any of the following procedures or conditions in the
- •preceding 6 months: coronary artery bypass graft, angioplasty, vascular
- •stent, myocardial infarction, angina pectoris, congestive heart failure
- •New York Heart Association
- •(NYHA) grade = 2
- •(e). Uncontrolled hypotension
- •(f). Cardiac ejection fraction outside institutional range of normal or <
- •50% (whichever is higher) unless the condition is considered stable and
- •not clinically significant by the investigator.
- •7. Any of these clinically significant abnormalities of glucose metabolism
- •at screening:
- •(a). diabetes mellitus type I or type II requiring insulin treatment
- •(b). HbA1c = 8.0% (63.9 mmol/mol)
- •8. Previous allogeneic bone marrow transplant or solid organ transplant.
- •9. For the phase III: Prior treatment with CDK4/6 inhibitors (in the
- •metastatic setting), a SERD, allosteric mTOR inhibitors, PI3K inhibitors
- •or AKT inhibitors in the metastatic setting.
研究者
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