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.
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. 1. 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. 2. 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. 3. To evaluate overall survival in patients who are ≥70 years of age using trastuzumab monotherapy or combined trastuzumab and chemotherapy. 4. 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. 5. To establish and expand information networks by the participation of practitioners in clinical trials that are involved in general clinical practice and breast cancer.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
275
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
Disease free survival
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
Time frame: Patients are followed up for 8 years after initial enrollment (from Oct. 2009 through Oct. 2017).
Overall survival
Overall survival is defined as the interval from the date of enrollment to the date of death from any cause.
Time frame: Patients are followed up for 8 years after initial enrollment (from Oct. 2009 through Oct. 2017).
Relapse-free survival
Relapse-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. Death
Time frame: 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
The following variables are evaluated: left ventricular ejection fraction, white-cell count, neutrophil count, platelet count, bilirubin level, alanine aminotransferase level, aspartate aminotransferase level, alkaline phosphatase level, and creatinine level.
Time frame: 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.
Health-related QOL (HRQOL)
The following QOL questionnaire forms (in Japanese) are used for evaluations: FACT-G, HADS, EQ-5D, and PNQ.
Time frame: Evaluations are performed at the time of starting the specified treatment and 2 months, 1 year, and 3 years after the start of treatment.
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Cost effectiveness analysis
Survey items are as follows. 1. Direct medical costs: medical costs associated with therapy, the management of adverse events, etc. 2. Direct nonmedical costs: transportation expenses required for medical examinations, costs of health foods, etc. 3. Indirect costs: work-loss costs associated with treatment that are incurred directly by the patient and by their caregivers
Time frame: 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.