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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.
breast cancer - adjuvant
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 emtasine plus endocrine therapy (n=-9) vs. trastuzumab based treatment (n=-9)
randomized controlled trial
Adjuvant Trastuzumab Emtansine
paclitaxel plus trastuzumab
breast cancer - adjuvant
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
sacituzumab govitecan (n=235) vs. Standard of Care (SoC) (n=233)
randomized controlled trial
Sacituzumab govitecan
10 mg per kilogram of body weight intravenously on days 1 and 8 of each 21-day cycle
single agent chemotheraopy² of the physician's choice (eribulin, vinorelbine, capecitabine or gemcitabine)
eribulin (1.4 mg per square meter of body-surface area in North-America or 1.23 mg per square meter in Europe, IV on days 1 and 8 of a 21-day cycle), vinorelbine (25 mg per square meter IV on day 1 weekly), capecitabine (1000 to 1250 mg per square meter orally twice daily on days 1 to 14 of a 21-day cycle), or gemcitabine (800 to 1200 mg per square meter IV on days 1, 8, and 15 of a 28-day cycle)
single-agent chemotherapy of the physician's choice (for comparator group)
mBC-Triple negative (TNBC) - 2nd Line (L2)
Patients with stable brain metastases for at least 4 weeks before treatment were eligible for the trial but were excluded from the primary end-point analysis.
open-label
88 sites in 7 countries (North America and Europe)
P3 / a hierarchical testing procedure (gatekeeping) will be implemented for testing the endpoints of PFS and OS, in this order: PFS (two-sided, at 0.05), then if significant, OS (two-sided, at 0.05)
Even though PFS and OS (both were part of the plan statistical analysis) seemed to be significantly longer in the sacituzumab govitecan group, in patients without brain metastases. However, these results are not conclusive because the study was ended in March 2020, before the scheduled end date.
sacituzumab govitecan (n=267) vs. Standard of Care (SoC) (n=262)
randomized controlled trial
Sacituzumab govitecan
10 mg per kilogram of body weight intravenously on days 1 and 8 of each 21-day cycle
single agent chemotheraopy of the physician's choice (eribulin, vinorelbine, capecitabine or gemcitabine)
eribulin (1.4 mg per square meter of body-surface area in North-America or 1.23 mg per square meter in Europe, IV on days 1 and 8 of a 21-day cycle), vinorelbine (25 mg per square meter IV on day 1 weekly), capecitabine (1000 to 1250 mg per square meter orally twice daily on days 1 to 14 of a 21-day cycle), or gemcitabine (800 to 1200 mg per square meter IV on days 1, 8, and 15 of a 28-day cycle)
single-agent chemotherapy of the physician's choice (for comparator group)
mBC-Triple negative (TNBC) - 2nd Line (L2)
Patients with stable brain metastases for at least 4 weeks before treatment were eligible for the trial but were excluded from the primary end-point analysis.
open-label
88 sites in 7 countries (North America and Europe)
P3 / a hierarchical testing procedure (gatekeeping) will be implemented for testing the endpoints of PFS and OS in BM-ve population (without brain metastasis) then, in all population, in this order: - PFS in BM-ve (two-sided, at 0.05), - then if significant, OS in BM-ve (two-sided, at 0.05) ;- then if significant PFS in all pop (two-sided, at 0.05),- then if significant, OS in all pop (two-sided, at 0.05)
Even though, PFS and OS (both were part of the plan statistical analysis) were significantly longer in the sacituzumab govitecan group, in patients without brain metastases. However, the study was ended in March 2020, before the scheduled end date, therefore the results are not conclusive.
trastuzumab deruxtecan (n=373) vs. chemotherapy (n=184)
randomized controlled trial
trastuzumab deruxtecan
physician’s choice of chemotherapy
metastatic/advanced - breast cancer (mBC)
Low expression of HER2 was defined as a score of 1 on immunohistochemical [IHC] analysis or as an IHC score of 2 and negative results on in situ hybridization
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