2023-505009-17-00已完成3 期
A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib + Paclitaxel Versus Placebo + Paclitaxel as First-line Treatment for Patients with Histologically Confirmed, Locally Advanced (Inoperable) or Metastatic Triple-Negative Breast Cancer (TNBC) (CAPItello-290)
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
To determine the efficacy of capivasertib + paclitaxel vs placebo + paclitaxel by OS (overall survival).
研究设计
- 研究类型
- Interventional
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
- 是
入选标准
- •Histologically confirmed TNBC from most recenty collected tumour tissue sample
- •Metastatic or locally advanced disease; locally advanced disease most not be amenable to resection with curative intent (patient who are considered suitble for surgical or ablative techniques following potential down-staging with study treatment are not eligible)
- •ECOG/WHO PS: 0-1
- •Measurable disease according to RECIST 1.1 and/or lytics or mixed bone lesions that can be assessed by CT or MRI in the absence of measurable disease
- •FFPE tumour sample from primary/recurrent cancer
排除标准
- •Prior treatment with any of the following treatments listed below. Patients are not eligible to enter the study if they have received any of the medications specified below or are unable to meet the cautions and restrictions : - Chemotherapy in the (neo)adjuvant setting within 6 months from the end of chemotherapy to the date of randomization; taxane chemotherapy in the (neo)adjuvant setting within 12 months from the end of chemotherapy to the start of randomization - Prior systematic therapy for inoperable locally advanced or metastatic disease - - AKT, PI3K, and/or mTOR inhibitors - Capivasertib in the present study (ie, any dosing with capivasertib due to previous participation in this study) - Any other immunotherapy, immunosuppressant medication (other than corticosteroids) or anticancer agents within 3 weeks of the first dose of study treatment. A longer washout may be required for drugs with a long half-life (eg, biologics) as agreed by the sponsor - Potent inhibitors or inducers of CYP3A4 within 2 weeks prior to the first dose of study treatment (3 weeks for St John's wort), or drug that are sensitive to CYP3A4, within 1 week prior to the first dose of study treatment
- •Radiotherapy with a wide field of radiation within 4 weeks before the first dose of study treatment (capivasertib/placebo)
- •Pre-existing sensory or motor polyneuropathy ≥grade 2 according to NCI CTCAE v5
- •With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
- •With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment
- •Any of the following cardiac criteria at screening: -Mean resting corrected QT interval (QTc) >470 msec obtained from 3 consecutive ECGs -Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG (eg, complete left bundle branch block, third degree heart block) - Any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, potential for Torsades de Pointes, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under 40 years of age or any concomitant medication known to prolong the QT interval - 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 -Uncontrolled hypotension – SBP <90 mmHg and/or DBP <50 mmHg - Cardiac ejection fraction outside institutional range of normal or <50% (whichever is higher) as measured by echocardiogram (or multiplegated acquisition [MUGA] scan if an echocardiogram cannot be performed or is inconclusive).
- •Clinically significant abnormalities of glucose metabolism as defined by any of the following at screening: -Patients with diabetes mellitus type I or diabetes mellitus type II requiring insulin treatment -HbA1c ≥8.0% (63.9 mmol/mol)
- •Inadequate bone marrow reserve or organ function at screening
- •Currently pregnant (confirmed with positive pregnancy test) or breast-feeding
结局指标
主要结局
Overall Survival
Overall Survival
次要结局
- Investigator assessment of PFS
- Investigator assessment of PFS2
- 3a Response Rate (ORR) - percentage of patients with at least one investigator-assessed visit response of complete or partial response (as assessed by the investigator, using RECIST 1.1).
- 3b Duration of Response (DoR) - time from the date of first documented response until date of documented progression (as assessed by the investigator, using RECIST 1.1) or death in the absence of disease progression
- 3c Clinical Benefit Rate (CBR) - number of patients with complete or partial response or with stable disease maintained ≥24 weeks (as assessed by the investigator, using RECIST 1.1) divided by the number of patients in the analysis.
- AEs/SAEs; vital signs; collection of clinical chemistry, haematology, glucose metabolism parameters; ECGs parameters.
- Plasma PK parameters derived from a population PK model of plasma concentrations and patient factors
- EORTC QLQ BR23 (EORTC Quality of Life Questionnaire breast cancer specific module) and EORTC QLQ C30 (EORTC Quality of Life Questionnaire Core 30 items) scale/item scores
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (1)
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