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ATEMPT, 2021 NCT01853748

trastuzumab emtasine plus endocrine therapy (n=-9) vs. trastuzumab based treatment (n=-9)

randomized controlled trial

Studied treatment

Adjuvant Trastuzumab Emtansine

Control treatment

paclitaxel plus trastuzumab

Patients

breast cancer - adjuvant

Method

Remark

Harbeck (TDM1 plus ET), 2017 NCT01817452

trastuzumab emtasine plus endocrine therapy (n=-9) vs. trastuzumab plus endocrine therapy (n=-9)

randomized controlled trial

Studied treatment

trastuzumab emtasine plus endocrine therapy
trastuzumab emtasine: 3.6mg/kg every 3weeks for 4 cycles / endorine therapy: tamoxifen in premenopausal women and aromatase inhibitors in postmenopausal women

Control treatment

trastuzumab plus endocrine therapy
trastuzumab: at a loading dose of 8 mg/kg and then 6 mg/kg every 3 weeks for 3 more cycles / endorine therapy: tamoxifen in premenopausal women and aromatase inhibitors in postmenopausal women

Gonadotropin-releasing hormone analogs were allowed in premenopausal patients

Patients

es-BC - HER2 positive - (neo)adjuvant (NA)

Exclusion criteria: nonoperable and inflammatory BC

Method

48 centers

P2 / 2 one-sided tests or proportions (arm A v arm C and arm B v armC) were planned at an a of .025 under the assumption of at least 25% pCRin both T-DM1 arms (arms A and, B), compared with a 10% pCR rate inthe trastuzumab arm (arm C)

Remark