EUCTR2020-004637-20-SE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
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
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 receptor.
- •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 setting.
- •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 525
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 175
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
- •XML File Identifier: 8+mTlXnWL8t5pF4g6HTY7ugmdTo=
- •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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