A Phase 3 interventional study of trastuzumab monotherapy and trastuzumab and chemotherapy in Breast Cancer, sponsored by Comprehensive Support Project for Oncology Research. Completed at 1 site in Japan. Open to female participants aged 70 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-10-21.
Sponsored by Comprehensive Support Project for Oncology Research · Phase 3, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 275 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Comprehensive Support Project for Oncology Research is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Sufficient organ function meeting following criteria within 4 weeks before registration:
Exclusion Criteria:
Any history or complication of following cardiac disorders
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
Drug: trastuzumab monotherapy
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.
Drug: trastuzumab monotherapy · Drug: trastuzumab and chemotherapy
Also known as: Herceptin
Also known as: PTX, DTX, TC, AC, EC, FEC, CMF, TCb (CBDCA)
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.
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.
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Comprehensive Support Project for Oncology Research