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trastuzumab emtansine (n=743) vs. trastuzumab (n=743)
randomized controlled trial
trastuzumab emtasine (T-DM1)
T-DM1: 3.6 mg per kg of body weight IV every 3 weeks for 14 cycles
trastuzumab
trastuzumab: 6 mg per kg IV every 3 weeks for 14 cycles (a loading dose of 8 mg of trastuzumab per kg was administered if more than 6 weeks had relapsed since the preceding dose of trastuzumab)
Patients who discontinued T-DM1 early because of toxic effects could complete 14 cycles of trial treatment with trastuzumab at the discretion of the investigator.
es-BC - HER2 positive - (neo)adjuvant (NA)
Exclusion criteria: gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery; progressive disease during neoadjuvant therapy; and cardiopulmonary dysfunction (heart failure NYHA class II or higher; or a history of a reduction in the left ventricular ejection fraction to less than 40% with previous therapy).
open-label
273 trial sites in 28 countries
P3 / hierarchical test, 5% (2-sided): IDFS > OS / 1 IA of IDFS (p value<0.0124 / final IDFS: p<0.0462) and 3 IA of OS (IA1: p<0.0009 / IA 2: p<0.0053 / AI 3: p<0.0184 / final OS: p<0.0435).
trastuzumab emtasine improves IDFS compare to trastuzumab to patients with non-metastatic HER2-positive BC
trastuzumab emtansine (n=119) vs. trastuzumab plus endocrine therapy (n=129)
randomized controlled trial
trastuzumab emtasine
trastuzumab emtasine: 3.6mg/kg every 3weeks for 4 cycles
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
es-BC - HER2 positive - (neo)adjuvant (NA)
Exclusion criteria: nonoperable and inflammatory BC
open label
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 in the trastuzumab arm (arm C)
trastuzumab emtasine plus endocrine therapy (n=-9) vs. trastuzumab plus endocrine therapy (n=-9)
randomized controlled trial
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
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
es-BC - HER2 positive - (neo)adjuvant (NA)
Exclusion criteria: nonoperable and inflammatory BC
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)
trastuzumab deruxtecan (n=-9) vs. trastuzumab emtansine (n=-9)
randomized controlled trial
trastuzumab deruxtecan
trastuzumab emtansine
la/mBC - HER2 positive - 2nd Line (L2)
trastuzumab emtansine (n=495) vs. lapatinib plus capecitabine (n=496)
randomized controlled trial
trastuzumab emtansine
trastuzumab emtansine: IV 3,6mg/kg of body weight every 21 days
lapatinib plus capecitabine
lapatinib: PO 1250mg daily / capecitabine: PO 1000 mg per square meter of body surface area every 12hours on days 1 through 14 of each 21-day cycle / both molecules were self-administered a,d patients recorded their doses in a patient diary.
la/mBC - HER2 positive - 2nd Line (L2)
exclusion criteria: prior treatment with TDM-1, lapatinib or capecitabine, peripheral neuropathy of grade 3 or more, CNS metastases.
open label
213 centers in 26 countries
P3 / The hypothesis test for PFS was conducted at a 2-sided alpha of 0.05. If the PFS was statistically significant, OS was tested at a 2-sided alpha of 0.05. One IA for OS (p=0.0003) was planned at the beginning, and a 2nd IA (p=0.0037) was added to the SAP after the completion of the first IA, and the final OS analysis with p < 0.0494 (in the protocol). If both PE were statistically significant, secondary endpoints were tested in a prespecified order : PFS (investigator assessment), response rate (independent review), time to treatment failure, and time to symptom progression
trastuzumab emtasine increased significantly PFS and OS compare to lapatinib plus capecitabine
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