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>DISEASE CHARACTERISTICS:</p><ul><li><p>Histologically confirmed adenocarcinoma of the breast</p><ul><li>Metastatic or recurrent disease</li></ul></li><li>Estrogen-receptor and/or progesterone-receptor positive disease</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 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</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>Prior investigational agents in the adjuvant setting must be discussed with the principal investigator</li></ul></li><li>No prior tamoxifen or other agents that modulate or downregulate the estrogen receptor (e.g., raloxifene, fulvestrant)</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 ≥ 6 weeks prior to study therapy</li></ul></li><li>Prior aromatase inhibitors (≤ 2 agents) (e.g., anastrozole, letrozole, exemestane, animoglutethimide) 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>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 prior to 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>
After
<p>DISEASE CHARACTERISTICS:</p><ul><li><p>Histologically confirmed adenocarcinoma of the breast</p><ul><li>Metastatic or recurrent disease</li></ul></li><li>Estrogen-receptor and/or progesterone-receptor positive disease</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 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</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>Prior investigational agents in the adjuvant setting must be discussed with the principal investigator</li></ul></li><li>No prior tamoxifen or other agents that modulate or downregulate the estrogen receptor (e.g., raloxifene, fulvestrant)</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 ≥ 6 weeks before study therapy</li></ul></li><li>Prior aromatase inhibitors (≤ 2 agents) (e.g., anastrozole, letrozole, exemestane, aminoglutethimide) 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>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>
Other registry fieldsChanges outside the current high-signal rule families.Triage: Uncategorized3 ops
<p>OBJECTIVES:</p><p>Primary</p><ul><li>To correlate CYP2D6 score (0 vs 1-2) and progression-free survival (PFS) of patients with metastatic breast cancer treated with tamoxifen citrate.</li></ul><p>Secondary</p><ul><li>To correlate CYP2D6 score (0 vs 1 vs 2) and PFS of patients treated with this regimen.</li><li>To correlate CYP2D6 score (0 vs 1 + 2) and the proportion of these patients who are PFS at 6 months.</li><li>To correlate endoxifen concentration with response in patients treated with this regimen.</li><li>To correlate CYP2D6 with response in patients treated with this regimen.</li><li>To correlate the presence of candidate estrogen receptor (ESR) 1 and 2 variant alleles, UGT7, SULT1A1, and other candidate genes to PFS.</li></ul><p>OUTLINE: This is a multicenter study.</p><p>Patients receive oral tamoxifen citrate once daily on days 1-28.
Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities.</p><p>Blood, plasma, and tissue samples are collected periodically for laboratory studies.</p><p>After completion of study therapy, patients are followed every 3-6 months for 5 years.</p>
After
<p>OBJECTIVES:</p><p>Primary</p><ul><li>To correlate CYP2D6 score (0 vs 1-2) and progression-free survival (PFS) of patients with metastatic breast cancer treated with tamoxifen citrate.</li></ul><p>Secondary</p><ul><li>To correlate CYP2D6 score (0 vs 1 vs 2) and PFS of patients treated with this regimen.</li><li>To correlate CYP2D6 score (0 vs 1 + 2) and the proportion of these patients who are PFS at 6 months.</li><li>To correlate endoxifen concentration with response in patients treated with this regimen.</li><li>To correlate CYP2D6 with response in patients treated with this regimen.</li><li>To correlate the presence of candidate estrogen receptor (ESR) 1 and 2 variant alleles, UGT7, SULT1A1, and other candidate genes to PFS.</li></ul><p>OUTLINE: This is a multicenter study.</p><p>Patients receive oral tamoxifen citrate once daily on days 1-28.
Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities.</p><p>Blood, plasma, and tissue samples are collected periodically for laboratory studies.</p><p>After completion of study therapy, patients are followed up every 3-6 months for 5 years.</p>
Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2010-07-07"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2010-07-08"
},
{
"op": "replace",
"path": "/protocolSection/descriptionModule/detailedDescription",
"value": "<p>OBJECTIVES:</p><p>Primary</p><ul><li>To correlate CYP2D6 score (0 vs 1-2) and progression-free survival (PFS) of patients with metastatic breast cancer treated with tamoxifen citrate.</li></ul><p>Secondary</p><ul><li>To correlate CYP2D6 score (0 vs 1 vs 2) and PFS of patients treated with this regimen.</li><li>To correlate CYP2D6 score (0 vs 1 + 2) and the proportion of these patients who are PFS at 6 months.</li><li>To correlate endoxifen concentration with response in patients treated with this regimen.</li><li>To correlate CYP2D6 with response in patients treated with this regimen.</li><li>To correlate the presence of candidate estrogen receptor (ESR) 1 and 2 variant alleles, UGT7, SULT1A1, and other candidate genes to PFS.</li></ul><p>OUTLINE: This is a multicenter study.</p><p>Patients receive oral tamoxifen citrate once daily on days 1-28.\nTreatment repeats every 28 days in the absence of disease progression or unacceptable toxicities.</p><p>Blood, plasma, and tissue samples are collected periodically for laboratory studies.</p><p>After completion of study therapy, patients are followed up every 3-6 months for 5 years.</p>"
},
{
"op": "replace",
"path": "/protocolSection/eligibilityModule/eligibilityCriteria",
"value": "<p>DISEASE CHARACTERISTICS:</p><ul><li><p>Histologically confirmed adenocarcinoma of the breast</p><ul><li>Metastatic or recurrent disease</li></ul></li><li>Estrogen-receptor and/or progesterone-receptor positive disease</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 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</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>Prior investigational agents in the adjuvant setting must be discussed with the principal investigator</li></ul></li><li>No prior tamoxifen or other agents that modulate or downregulate the estrogen receptor (e.g., raloxifene, fulvestrant)</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 ≥ 6 weeks before study therapy</li></ul></li><li>Prior aromatase inhibitors (≤ 2 agents) (e.g., anastrozole, letrozole, exemestane, aminoglutethimide) 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>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>"
}
]