Aphinity, trial summary

A randomised clinical trial investigating the effect of pertuzumab versus placebo in people with operable HER2-positive eBC

NCT01358877    




Studied treatment
Six to eight cycles of chemotherapy (anthracycline or non-anthracycline-containing regimen) with Perjeta and Herceptin, followed by Perjeta and Herceptin every three weeks for a total of one year (52 weeks) of treatment
Control treatment
Six to eight cycles of chemotherapy (anthracycline or non-anthracycline-containing regimen) with placebo and Herceptin, followed by placebo and Herceptin every three weeks for a total of one year (52 weeks) of treatment



Patients people with operable HER2-positive eBC
Group sizes 4805 / 0



Blindness double-blind Inclusion period
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint iDFS Design Parallel groups



EndpointX1N1X0N0TE95% CI Neutropenic fever - all studies - -9 - -9 no data CHF stratified by duration of trastuzumab administration - -9 - -9 no data Brain metastases - all studies - -9 - -9 no data Neutropenic fever stratified by duration of trastuzumab administration - -9 - -9 no data CHF stratified by type of trastuzumab administration - -9 - -9 no data Brain metastases stratified by duration of trastuzumab administration - -9 - -9 no data Anaemia - all studies - -9 - -9 no data Left Ventricular Ejection Fraction (LVEF) decline - all studies - -9 - -9 no data Brain metastases stratified by type of trastuzumab administration - -9 - -9 no data Anaemia stratified by duration of trastuzumab administration - -9 - -9 no data LVEF decline stratified by duration of trastuzumab administration - -9 - -9 no data Neutropenia - all studies - -9 - -9 no data LVEF decline stratified by type of trastuzumab administration - -9 - -9 no data Congestive Heart Failure (CHF) - all studies - -9 - -9 no data Neutropenia stratified by duration of trastuzumab administration - -9 - -9 no data0,22,01,0




Registering number NCT01358877 (see trial on clinicaltrials.gov)
Code Name BO25126, BIG 4-11

 




Appears in following systematic reviews: