EUCTR2020-004637-20-FR进行中（未招募）1 期
A Phase Ib/III Randomised Study of Capivasertib plus Palbociclib and Fulvestrant versus Placebo plus Palbociclib 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
- 700
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. Eligible for palbociclib and fulvestrant therapy as per investigator assessment.
- •4. Adequate organ and bone marrow functions.
- •5. Consent to provide a mandatory FFPE tumour sample.
- •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 with a wide field of radiation within 4 weeks prior to study treatment initiation and/or radiotherapy with a limited field of radiation for palliation within 2 weeks prior to study treatment initiation. Patients who received prior radiotherapy to =25% of bone marrow are not eligible independent of when it was received.
- •3. Major surgery (excluding placement of vascular access) within 4 weeks of the first dose of study treatment.
- •4. Persistent toxicities (CTCAE Grade >1) caused by previous anticancer therapy, excluding alopecia. Participants with irreversible toxicity that is not reasonably expected to be exacerbated by study intervention may be included (eg, hearing loss) after consultation with the AstraZeneca study physician.
- •5. Spinal cord compression, brain metastases or leptomeningeal metastases unless asymptomatic, treated and stable and not requiring steroids within 4 weeks prior to study treatment initiation.
- •6. Any of the following cardiac criteria at screening:
- •(a). Mean resting corrected QT interval (QTc) > 470 msec obtained from 3 consecutive ECGs
- •(b). Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third-degree heart 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)
- •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 (any setting), a SERD (including unlicensed SERDs), allosteric mTOR inhibitors (e.g. everolimus), PI3K inhibitors (e.g. alpelisib) or AKT inhibitors.
研究者
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