NCT01124695

Tamoxifen Citrate in Treating Patients With Metastatic or Recurrent Breast Cancer

Version 1 to 2 · ECOG-ACRIN Cancer Research Group

Patch inspector

Version 1 to 2

3 operations 2 path groups ctgov_internal_history

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.

Plain-language summary

Manual review pending.

Rules fired

eligibility_criteria_change

Value signals

None recorded.

Provenance

Source: ctgov_internal_history
Fetched: 2026-06-18 19:13:32+00
Raw hash: 39b35de801de7256c1a61b4d98a2e4ce34a2e590ea897c3e799c8c104b9dfe5c
Payload: Source URL

Eligibility Criteria and population definition changes. Triage: High 1 ops

replace /protocolSection/eligibilityModule/eligibilityCriteria

Triage: High

Eligibility Change Operation 3

Matched rules

eligibility_criteria_change Eligibility 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&#x2F;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>

After

<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>Estrogen-receptor and&#x2F;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 fields Changes outside the current high-signal rule families. Triage: Uncategorized 2 ops

replace /protocolSection/statusModule/lastUpdateSubmitDate

Triage: Uncategorized

Uncategorized Operation 1

Before

2010-07-07

After

2010-09-11

replace /protocolSection/statusModule/lastUpdatePostDateStruct/date

Triage: Uncategorized

Uncategorized Operation 2

Before

2010-07-08

After

2010-09-14

Raw JSON Patch

[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2010-09-11"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2010-09-14"
  },
  {
    "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>Estrogen-receptor and&#x2F;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>"
  }
]