Severity is deterministic uncalibrated triage metadata, not validated review priority. Operation-level severity
is inferred from deterministic path rules. Rule matches shown per operation are approximate previews (they skip
the pipeline's suppression passes); the authoritative classification is the stored
event record.
eligibility_criteria_changeEligibility criteria changes can alter the studied population.
Before
<p>Inclusion Criteria:</p><ol><li>Able to give written informed consent and to comply with the protocol</li><li>Stage IV oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and/or metastasis</li><li>Female of age 18 years or above</li><li>Patients who are indicated to received first line chemotherapy with weekly paclitaxel</li><li>Evidence of measurable disease as defined by Response Evaluation Criteria version 1.1</li></ol><p>6 Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population.</p><p>Exclusion Criteria:</p><ol><li>Prior chemotherapy for metastatic breast adenocarcinoma</li><li>Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy</li><li>Inflammatory carcinoma</li><li>Candidate for treatment with trastuzumab (or other Her2/neu targeted agents)</li><li>Systemic chemotherapy,radiation therapy or any other investigational agent within 4 weeks, endokrine therapy within 1 week prior to first dose of study treatment and until completion of study treatment</li><li>Symptomatic known cerebral and/or leptomeningeal metastases</li><li>Serious intercurrent infection</li><li>Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment</li><li>Active acute or chronic infection</li><li>Active autoimmune disease requiring immunosuppressive therapy</li><li>Previous malignancies within the last three years other than breast carcinoma</li><li>Patients with prior organ or stem cell transplantation</li><li>Any condition requiring continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.</li></ol>
After
<p>Inclusion Criteria:</p><ol><li>Able to give written informed consent and to comply with the protocol</li><li>Metastatic oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and/or metastasis</li><li>Female of age 18 years or above</li><li>Patients who are indicated to received first line chemotherapy with weekly paclitaxel</li><li>Evidence of measurable disease as defined by Response Evaluation Criteria version 1.1</li></ol><p>6 Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population.</p><p>Exclusion Criteria:</p><ol><li>Prior chemotherapy for metastatic breast adenocarcinoma</li><li>Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy</li><li>Inflammatory carcinoma</li><li>Candidate for treatment with trastuzumab (or other Her2/neu targeted agents)</li><li>Systemic chemotherapy,radiation therapy or any other investigational agent within 4 weeks, endokrine therapy within 1 week prior to first dose of study treatment and until completion of study treatment</li><li>Symptomatic known cerebral and/or leptomeningeal metastases</li><li>Serious intercurrent infection</li><li>Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment</li><li>Active acute or chronic infection</li><li>Active autoimmune disease requiring immunosuppressive therapy</li><li>Previous malignancies within the last three years other than breast carcinoma</li><li>Patients with prior organ or stem cell transplantation</li><li>Any condition requiring continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.</li></ol>
Contacts and locationsSite, contact, and location updates that are usually operational.Triage: Uncategorized3 ops
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2017-08"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2017-08-04"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2017-08-07"
},
{
"op": "replace",
"path": "/protocolSection/eligibilityModule/eligibilityCriteria",
"value": "<p>Inclusion Criteria:</p><ol><li>Able to give written informed consent and to comply with the protocol</li><li>Metastatic oestrogen receptor positive and/or progesterone receptor positive breast adenocarcinoma, histologically proven by biopsy of the primary tumour and/or metastasis</li><li>Female of age 18 years or above</li><li>Patients who are indicated to received first line chemotherapy with weekly paclitaxel</li><li>Evidence of measurable disease as defined by Response Evaluation Criteria version 1.1</li></ol><p>6 Laboratory criteria: haematology and biochemistry results within the limits normally expected for the patient population.</p><p>Exclusion Criteria:</p><ol><li>Prior chemotherapy for metastatic breast adenocarcinoma</li><li>Disease-free interval of less than twelve months from the last dose of adjuvant chemotherapy</li><li>Inflammatory carcinoma</li><li>Candidate for treatment with trastuzumab (or other Her2/neu targeted agents)</li><li>Systemic chemotherapy,radiation therapy or any other investigational agent within 4 weeks, endokrine therapy within 1 week prior to first dose of study treatment and until completion of study treatment</li><li>Symptomatic known cerebral and/or leptomeningeal metastases</li><li>Serious intercurrent infection</li><li>Evidence of severe or uncontrolled cardiac disease (NYHA III-IV) within 6 months prior to first dose of study treatment</li><li>Active acute or chronic infection</li><li>Active autoimmune disease requiring immunosuppressive therapy</li><li>Previous malignancies within the last three years other than breast carcinoma</li><li>Patients with prior organ or stem cell transplantation</li><li>Any condition requiring continuous systemic treatment with either corticosteroids or other immunosuppressive medications within 4 weeks prior to first dose of study treatment.</li></ol>"
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/15/status",
"value": "RECRUITING"
},
{
"op": "add",
"path": "/protocolSection/contactsLocationsModule/locations/18",
"value": {
"zip": "1081",
"city": "Amsterdam",
"status": "NOT_YET_RECRUITING",
"country": "Netherlands",
"facility": "VU University Medical Center",
"geoPoint": {
"lat": 52.37403,
"lon": 4.88969
}
}
},
{
"op": "replace",
"path": "/protocolSection/contactsLocationsModule/locations/29/status",
"value": "RECRUITING"
}
]