Randomized Phase II Study of Personalized Antiemetic Regimen Based on Pharmacogenetic Profile for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Chinese Breast Cancer Patients.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Complete Protection (CP)
研究概览
简要总结
The objectives of this study are to determine if pharmacogenetic (PG) analysis of an individual enable optimal selection of antiemetic regimen for patients undergoing the first cycle of AC (Adriamycin + Cyclophosphamide) or FEC (Fluorouracil + Epirubicin + Cyclophosphamide) chemotherapy. It also aims to compare the quality of life of patients in the first cycle of AC / FEC chemotherapy with and without PG analysis.
Patients will be randomized to undergo PG analysis [PG group] versus no PG analysis [Non-/+PG group]. Those in the PG group would be offered currently available optimal antiemetic prophylaxis, with or without Olanzapine according to PG outcomes. Those in the Non-PG group would be offered currently available optimal antiemetic prophylaxis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Chinese patient, female >/=18 and < 75 years of age.
- •Patient is diagnosed with early breast cancer.
- •Patient is naïve to emetogenic chemotherapy moderately or highly emetogenicity.
- •Patient is scheduled to receive her first course of neoadjuvant/adjuvant chemotherapy for breast cancer follows: AC: Intravenous (IV) Adriamycin 60 mg/m^2 + Cyclophosphamide 600 mg/m^2, given as 14-day cycle or 21-day cycle, or FEC: IV Fluorouracil 500 mg/m^2 + Epirubicin 50 mg/m^2 + Cyclophosphamide 500 mg/m^2, given as 21-day cycle
- •Patient has a predicted life expectancy of 4 months.
- •Patient has ECOG (Eastern Cooperative Oncology Group) Performance Status of 0-
- •Premenopausal female patients must not be pregnant (documented negative urine pregnancy test).
- •Patient is able to read, understand and complete study questionnaires and diary, including questions requiring a visual analog scale (VAS) response.
- •Patient understands the procedures and agrees to participate in the study by giving written informed consent.
排除标准
- •Patient with advanced breast cancer.
- •Patient receiving cisplatin or any other chemotherapy of higher emetogenic potential, except for cyclophosphamide and doxorubicin in the regimens described above.
- •Patients who are scheduled to receive concurrent radiation as part of their chemotherapy regimen for their malignancy
- •Patients who experience any vomiting or grade 2-3 nausea per Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.03) in the 24 hours before Day 1 of chemotherapy
- •Patient has a history of treatment with moderately to highly emetogenic chemotherapy.
- •Patient has an active infection (e.g., pneumonia, systemic fungal infection) or any uncontrolled disease (e.g., diabetes mellitus, hypertension) which, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.
- •Patient with history of glaucoma, dementia, seizures, Parkinson's disease, Neuroleptic Malignant Syndrome (NMS), thromboembolic events.
- •Patient currently uses any illicit drugs, including marijuana, or has current evidence of alcohol abuse as determined by the investigator.
- •Patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.
- •Patients who are regular alcohol drinker or smoker
- •Patient has a history of any illness that, in the opinion of the investigator, might confound the results of the study or pose unwarranted risk.
- •Patient has a history of hypersensitivity to aprepitant, ondansetron or dexamethasone.
- •Patients who have phenylketonuria and abnormal uric acid.
- •Any investigational drugs taken within 4 weeks prior to Day 1 of cycle 1, and/or is scheduled to receive any investigational drug during the study.
研究组 & 干预措施
PG arm
In PG arms, there are 4 PG subgroups:
- Subgroup A: Standard antiemetic regimen will be given.
- Subgroup B: Standard antiemetic regimen will be given.
- Subgroup C: Olanzapine antiemetic regimen will be given.
- Subgroup D: Olanzapine antiemetic regimen will be given.
干预措施: Standard antiemetic regimen or Olanzapine antiemetic regimen (Drug)
Non-PG arm
Standard antiemetic regimen will be given.
干预措施: Standard antiemetic regimen (Drug)
结局指标
主要结局
Complete Protection (CP)
时间窗: 2 years
CP was defined as no vomiting, no use of rescue therapy and 'no significant nausea' (NSN) during the study periods. NSN is defined as a nausea VAS of \<25 mm.
次要结局
- No Nausea (NN)(2 years)
研究者
Winnie Yeo
Professor, Department of Clinical Oncology
Chinese University of Hong Kong