Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2015-03-16"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2015-03-17"
},
{
"op": "replace",
"path": "/protocolSection/descriptionModule/briefSummary",
"value": "This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, PIK3CA-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy.\nThere will be a 2:1 randomization to the taselisib arm versus the placebo arm.\nEnrollment will be enriched for patients with PIK3CA mutant tumors via central testing.\nThe anticipated duration of the study is approximately 3.5 years."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/measure",
"value": "Overall objective response rate (partial response [PR] plus complete response [CR]), as determined by using RECIST v.1.1"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/75",
"value": {
"zip": "23007",
"city": "Jaén",
"state": "Jaen",
"status": "NOT_YET_RECRUITING",
"country": "Spain",
"geoPoint": {
"lat": 37.76922,
"lon": -3.79028
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/78",
"value": {
"zip": "28033",
"city": "Madrid",
"state": "Madrid",
"status": "NOT_YET_RECRUITING",
"country": "Spain",
"geoPoint": {
"lat": 40.4165,
"lon": -3.70256
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/79",
"value": {
"zip": "38320",
"city": "San Cristóbal de La Laguna",
"state": "Tenerife",
"status": "NOT_YET_RECRUITING",
"country": "Spain",
"geoPoint": {
"lat": 28.4853,
"lon": -16.32014
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/80",
"value": {
"zip": "46980",
"city": "Valencia",
"state": "Valencia",
"status": "NOT_YET_RECRUITING",
"country": "Spain",
"geoPoint": {
"lat": 39.47391,
"lon": -0.37966
}
}
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/81",
"value": {
"zip": "48903",
"city": "Barakaldo",
"state": "Vizcaya",
"status": "RECRUITING",
"country": "Spain",
"geoPoint": {
"lat": 43.29639,
"lon": -2.98813
}
}
}
]