Raw JSON Patch
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"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2012-11"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/primaryCompletionDateStruct/date",
"value": "2016-07"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2012-11-16"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2012-11-19"
},
{
"op": "replace",
"path": "/protocolSection/eligibilityModule/eligibilityCriteria",
"value": "<p>DISEASE CHARACTERISTICS:</p><ul><li><p>Histologically confirmed adenocarcinoma of the breast</p><ul><li>Stage III (locally advanced), metastatic, or recurrent disease</li><li>Deemed not resectable</li></ul></li><li><p>Estrogen-receptor and/or progesterone-receptor positive disease</p><ul><li>Receptor status is based on most recent results</li><li>Receptor testing on metastatic disease is not required</li></ul></li><li>Measurable or non-measurable disease</li><li><p>History of CNS metastasis allowed provided it has been treated (surgery, radiotherapy, or radiosurgery) within the past 4 weeks and does not require medications to control symptoms</p><ul><li>No known leptomeningeal disease allowed</li></ul></li></ul><p>PATIENT CHARACTERISTICS:</p><ul><li>ECOG performance status 0-2</li><li>Menopausal status not specified</li><li>Total bilirubin ≤ 1.5 times upper limit of normal (ULN)</li><li>ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases present)</li><li>Not pregnant or nursing</li><li>Negative pregnancy test</li><li>Fertile patients must use effective nonhormonal contraception</li><li>No medical or psychiatric conditions that would interfere with protocol compliance, the ability to provide informed consent, assessment of response, or anticipated toxicities</li><li>More than 5 years since prior invasive malignancies except curatively treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix</li></ul><p>PRIOR CONCURRENT THERAPY:</p><ul><li>See Disease Characteristics</li><li><p>No prior investigational agents in the metastatic setting</p><ul><li>Other prior investigational agents in any setting must have been completed at least 6 weeks prior to study registration and should be discussed with the study PI</li></ul></li><li><p>Prior tamoxifen as adjuvant treatment is allowed as long as the patient did not have disease relapse or progression while on adjuvant tamoxifen or within 4 weeks of last dose</p><ul><li>Prior tamoxifen for advanced disease is not allowed</li></ul></li><li><p>No prior chemotherapy or trastuzumab (Herceptin) for metastatic disease</p><ul><li>Prior chemotherapy, trastuzumab, or bevacizumab in the adjuvant setting allowed provided it has been completed ≥ 4 weeks before study therapy</li></ul></li><li><p>Patients must not have had more than 2 lines of non-hormonal treatment in the locally advanced or metastatic setting, including trastuzumab (Herceptin), bevacizumab, or other biologics</p><ul><li>Treatment in the advanced setting must have been completed at least 2 weeks prior to study initiation</li></ul></li><li>Prior aromatase inhibitors (e.g., anastrozole, letrozole, exemestane, aminoglutethamide) are allowed in the adjuvant or metastatic setting</li><li><p>At least 2 weeks since prior and no concurrent medications that are strong to moderate inhibitors of CYP2D6 and may alter tamoxifen citrate metabolism including, but not limited to, any of the following:</p><ul><li>Paroxetine (Paxil)</li><li>Fluoxetine (Prozac)</li><li>Bupropion (Wellbutrin)</li><li>Quinidine (Cardioquin)</li></ul></li><li><p>Patients may not initiate bisphosphonate therapy while receiving treatment on this study</p><ul><li>Patients who have begun receiving bisphosphonate therapy prior to registration may continue at the same intervals used prior to study registration</li></ul></li><li><p>Concurrent radiotherapy to painful sites of bone disease or areas of impending fractures allowed provided the following criteria are met:</p><ul><li>Radiotherapy was initiated before study entry</li><li>Sites of measurable or non-measurable disease are outside the radiotherapy port</li><li>Recovered from prior radiotherapy</li></ul></li><li>No other concurrent hormonal therapy</li><li>No concurrent chemotherapy</li></ul>"
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"value": "Tony A. Flippin"
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