临床试验/NCT01104935

NCT01104935已完成3 期

Evaluation of Trastuzumab Without Chemotherapy as a Postoperative Adjuvant Therapy in HER2 Positive Elderly Breast Cancer Patients: Randomized Controlled Trial

Comprehensive Support Project for Oncology Research1 个研究点分布在 1 个国家目标入组 275 人开始时间: 2009年10月28日最近更新: 2019年10月21日

适应症

干预措施

试验速览

阶段: 3 期
状态: 已完成
发起方
入组人数: 275
试验地点: 1
主要终点: Disease free survival

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

To investigate clinical positioning between trastuzumab (Herceptin) monotherapy (H group) and combination therapy of trastuzumab and chemotherapy (H+CT group) based on a randomized controlled trial in women over 70 years with human epidermal growth factor receptor type-2 (HER2) positive primary breast cancer.

详细描述

This study is a randomized, comparative trial of postoperative adjuvant therapies in women with HER2 (human epidermal growth factor receptor type-2)-positive primary breast cancer who are ≥70 years of age that will compare trastuzumab (Herceptin®) monotherapy (H group) and trastuzumab in combination with chemotherapy (H+CT group).

The objectives of this study are as follows.

To verify the clinical positioning of trastuzumab monotherapy and combined trastuzumab and chemotherapy as postoperative adjuvant therapies for the treatment of HER2-positive primary breast cancer patients who are ≥70 years of age.
To evaluate the safety of trastuzumab monotherapy and combined trastuzumab and chemotherapy in patients who are ≥70 years of age. In particular, to evaluate cardiac disorders that are a characteristic adverse drug reaction of trastuzumab as well as geriatric-related concerns including lipid metabolism, cerebral infarction and cognitive disorders.
To evaluate overall survival in patients who are ≥70 years of age using trastuzumab monotherapy or combined trastuzumab and chemotherapy.
To evaluate health-related quality of life (HRQOL), cost-effectiveness (utility), and conduct a comprehensive geriatric assessment (CGA) in patients who are ≥70 years of age and using trastuzumab monotherapy or combined trastuzumab and chemotherapy.
To establish and expand information networks by the participation of practitioners in clinical trials that are involved in general clinical practice and breast cancer.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: None

入排标准

年龄范围: 70 Years 至 80 Years（Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Histologically diagnosed as invasive breast cancer and received curative operation for primary breast cancer.
•Stage: 1 (tumor size [pT] > 0.5 cm), 2A, 2B or 3A/ M0
•Female between 70 and 80 years old
•Primary region is HER 2 positive: either 3+ overexpression by IHC or positive by FISH
•Baseline left ventricular ejection fraction (LVEF) is ≥55% measured by echocardiography or MUGA scan within 4 weeks before registration.
•PS: 0-1 (ECOG)
•Sufficient organ function meeting following criteria within 4 weeks before registration:
•Leukocyte ≥2500 mm3
•Neutrophil ≥1500 mm3
•Platelet ≥100 000 mm3
•Serum total bilirubin ≤2.0 x upper limit of normal (ULN)
•ALT (GPT) or AST (GOT) ≤2.5 x ULN
•Serum creatinine ≤2.0 x ULN
•ALP ≤2.5 x ULN
•No previous endocrine therapy or chemotherapy for breast cancer
•Signed written informed consent

排除标准

•Active multiple primary cancer (synchronous multiple primary cancer and invasive cancer of other organs)
•Postoperative histological axillary lymph node metastasis ≥4
•Axillary lymph node is not histologically evaluated
•Histologically confirmed positive margin in breast conservation surgery (evaluation of margin status is based on policy of site)
•History of drug-related allergy which could hinder planned treatment
•Any history or complication of following cardiac disorders
•History of congestive heart failure, cardiac infarction
•Complication requires treatment such as: ischemic cardiac disorder, arrhythmia, valvular heart disease
•Poorly controlled hypertension (ex. Systolic arterial pressure ≥180 mmHg or diastolic blood pressure ≥100 mmHg)
•Poorly controlled diabetes
•Continuous visit to a medial institution is considered difficult due to deterioration of activity of daily living (ADL)
•Difficult to participate in the trial because of psychiatric disorder or psychiatric symptoms
•Ineligible to the trial based on decision of an investigator

研究组 & 干预措施

trastuzumab monotherapy

Experimental

H group (trastuzumab monotherapy group)

Trastuzumab: 1-year treatment
Loading dose, 8 mg/kg; from 2nd dose, 6 mg/kg; iv inj, qw, 18 times

干预措施: trastuzumab monotherapy (Drug)

trastuzumab and chemotherapy

Active Comparator

H+CT group (combination therapy of trastuzumab and chemotherapy)

Chemotherapy: 12 to 24 weeks
Select chemotherapy from certain regimens (PTX, DTX, TC, AC, EC, FEC, CMF and TCb (CBDCA)) based on decision of a physician or a patient. Initiate administration of trastuzumab after completion of chemotherapy as a sequential combination. However, concomitant administration is allowed when combining trastuzumab with PTX, DTX and CMF. In cases of TCb (CBDCA), trastuzumab is used concomitant administration.

干预措施: trastuzumab monotherapy (Drug)

trastuzumab and chemotherapy

Active Comparator

H+CT group (combination therapy of trastuzumab and chemotherapy)

Chemotherapy: 12 to 24 weeks
Select chemotherapy from certain regimens (PTX, DTX, TC, AC, EC, FEC, CMF and TCb (CBDCA)) based on decision of a physician or a patient. Initiate administration of trastuzumab after completion of chemotherapy as a sequential combination. However, concomitant administration is allowed when combining trastuzumab with PTX, DTX and CMF. In cases of TCb (CBDCA), trastuzumab is used concomitant administration.

干预措施: trastuzumab and chemotherapy (Drug)

结局指标

主要结局

Disease free survival

时间窗: Patients are followed up for 8 years after initial enrollment (from Oct. 2009 through Oct. 2017).

Disease-free survival is defined as the interval from the date of enrollment to the date of any of the following events. 1. Local recurrence, distant metastasis 2. Metachronous breast cancer, secondary cancer 3. Death

次要结局

Relapse-free survival(Patients are followed up for 8 years after initial enrollment (from Oct. 2009 through Oct. 2017).)
Health-related QOL (HRQOL)(Evaluations are performed at the time of starting the specified treatment and 2 months, 1 year, and 3 years after the start of treatment.)
Overall survival(Patients are followed up for 8 years after initial enrollment (from Oct. 2009 through Oct. 2017).)
Percentage of participants with adverse events as a measure of safety(Evaluations are performed at the time of starting the specified treatment and 2, 6, and 9 month, 1 year, 1 year 6 months, 2 years, 2 years 6 months, and 3 years after the start of treatment. Subsequently, evaluations are done at 1-year intervals.)
Cost effectiveness analysis(Data on direct medical costs for the 3-year period after the start of the treatment are obtained from CRF. Data on direct nonmedical costs and indirect costs are obtained from questionnaires 2, 12, and 36 months after starting the treatment.)

研究者

发起方

Comprehensive Support Project for Oncology Research

申办方类型

Other

责任方

Sponsor

研究点 (1)

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