Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2018-04"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/overallStatus",
"value": "RECRUITING"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/startDateStruct/date",
"value": "2018-04"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2018-04-25"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2018-04-27"
},
{
"op": "add",
"path": "/protocolSection/oversightModule/isUsExport",
"value": true
},
{
"op": "replace",
"path": "/protocolSection/descriptionModule/detailedDescription",
"value": "Based on Ki67 levels after two weeks of initial letrozole treatment in postmenopausal patients with hormone receptor positive, HER2 negative, stage II/III breast cancer, patients are either advised to continue letrozole treatment (if Ki67 <1%) or will be randomized between standard chemotherapy (dose dense AC-T) or ribociclib in combination with letrozole (if Ki67 ≥1%)."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/1/description",
"value": "All patients initially start with two weeks of letrozole treatment.\nPatients with a Ki67 of ≥1% in the biopsy taken after those two weeks of treatment are randomized between chemotherapy (standard dose dense AC-T chemotherapy) or ribociclib plus letrozole (ribociclib 600 mg/day (days 1-21, q4 weeks) plus letrozole 2.5 mg daily (days 1-28, q4 weeks))."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/armGroups/2/description",
"value": "All patients initially start with two weeks of letrozole treatment.\nPatients with a Ki67 of ≥1% in the biopsy taken after those two weeks of treatment are randomized between chemotherapy (standard dose dense AC-T chemotherapy) or ribociclib plus letrozole (ribociclib 600 mg/day (days 1-21, q4 weeks) plus letrozole 2.5 mg daily (days 1-28, q4 weeks))."
},
{
"op": "replace",
"path": "/protocolSection/armsInterventionsModule/interventions/1/description",
"value": "Dose dense AC-T chemotherapy: 4 cycles of AC (doxorubicin and cyclophosphamide at a dose of 60 and 600 mg/m² as an i.v.\nbolus, respectively) 2-weekly plus G-CSF 24-48 hr after chemotherapy, followed by cycles of T (4 cycles docetaxel 100 mg/m² 3-weekly or 12 cycles paclitaxel 80 mg/m² weekly)."
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/0/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/1/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/2/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/3/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/4/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/5/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/6/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/7/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/8/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/9/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/10/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/11/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/12/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/13/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/14/status",
"value": "RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/15/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/16/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/17/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/18/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/19/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/20/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/21/status",
"value": "NOT_YET_RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/22/status",
"value": "NOT_YET_RECRUITING"
}
]