Study | study type
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Pathology | T1 | T0 | Patients | sample sizes | ROB | Results | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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es-BC - HER2 positive - (neo)adjuvant (NA) breast cancer - HER2-positive es-BC - HER2 positive - (neo)adjuvant (NA) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
versus trastuzumab | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
trastuzumab emtansine | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
KATHERINE, 2019 NCT01772472 | RCT | es-BC - HER2 positive - (neo)adjuvant (NA) | trastuzumab emtasine (T-DM1) | trastuzumab | Patients had histologically confirmed, HER2-positive, nonmetastatic, invasive primary breast cancer and if residual invasive disease after completion of taxane-based neoadjuvant chemotherapy ad and had to have completed at least six cycles (16 weeks) of a conventional preoperative chemotherapy regimen containing a minimum of 9 weeks of taxane-based therapy and 9 weeks of trastuzumab therapy. | 743 / 743 | high | conclusif |
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versus trastuzumab plus endocrine therapy | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
trastuzumab emtansine | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Harbeck (TDM-1), 2017 | RCT | es-BC - HER2 positive - (neo)adjuvant (NA), es-BC - HR positive - (neo)adjuvant (NA) | trastuzumab emtasine | trastuzumab plus endocrine therapy | Women older than 18yr with histologically confirmed unilateral primary BC, no evidence of distant metastasis, ER and/or PR-positive and HER2-positive who were candidates for neoadjuvant chemotherapy were eligible | 119 / 129 | NA | suggested |
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trastuzumab emtasine plus endocrine therapy | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Harbeck (TDM1 plus ET), 2017 NCT01817452 | RCT | es-BC - HER2 positive - (neo)adjuvant (NA), es-BC - HR positive - (neo)adjuvant (NA) | trastuzumab emtasine plus endocrine therapy | trastuzumab plus endocrine therapy | Women older than 18yr with histologically confirmed unilateral primary BC, no evidence of distant metastasis, ER and/or PR-positive and HER2-positive who were candidates for neoadjuvant chemotherapy were eligible | -/- | NA | suggested |
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