NCT01033032

Trial of Amrubicin as Treatment for Patients With HER2-Negative Metastatic Breast Cancer

Version 2 to 3 · SCRI Development Innovations, LLC

Patch inspector

Version 2 to 3

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 18:59:40+00
Raw hash: 6162333be7ada11dcef84e7c8b6ab5e6fb704b43f605fc0c254d551c75dbd549
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>Inclusion Criteria:</p><ol><li>Females &gt;=18 years of age.</li><li><p>Histologic diagnosis of HER2-negative breast cancer.
HER-2 negativity must be confirmed by one of the following:</p><ul><li>FISH-negative (FISH ratio &lt;2.2), or</li><li>IHC 0-1+, or</li><li>IHC 2-3+ AND FISH-negative (FISH ratio &lt;2.2)</li></ul></li><li>Evidence of metastatic or locally advanced, inoperable breast cancer.</li><li>Minimum of 1 and maximum of 2 prior metastatic breast cancer chemotherapy regimens.</li><li>Previous treatment with an anthracycline in the metastatic breast cancer setting.</li><li>Measurable disease per RECIST criteria version 1.1</li><li>Left ventricular ejection fraction (LVEF) ³50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).</li><li>Patients must have QTc interval of &lt;=450 msec.</li><li>No intercurrent significant medical conditions or cardiac illness.</li><li>Patients must be &gt;=3 weeks since last chemotherapy, and recovered from all acute toxicities, with the exception of alopecia.</li><li>Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2.</li><li><p>Adequate organ function including the following:</p><ul><li>ANC &gt;=1500 cells&#x2F;mL</li><li>Platelet count &gt;=100,000 cells&#x2F;mL</li><li>Hemoglobin &gt;=9 g&#x2F;dL</li><li>Total bilirubin &lt;=1.5 x ULN; AST&#x2F;ALT &lt;=2.5 x ULN, (except if due to hepatic metastases, then &lt;=5 x ULN)</li><li>Serum creatinine &lt;1.5 x ULN</li></ul></li><li>Women of childbearing potential must have a negative serum or urine pregnancy test performed &lt;=7 days prior to start of treatment.
If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.</li><li>Patients must be accessible for treatment and follow-up.</li><li>Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.</li><li>Patients who are on anticoagulation are acceptable if the therapeutic anticoagulation is stable.
Additionally, the patient&#x27;s INR must be adequate if the patient is receiving treatment with coumadin.</li><li>Prior hormonal therapy for metastatic breast cancer is permitted; however, the therapy must be discontinued prior to the patient&#x27;s enrollment in this study.</li></ol><p>Exclusion Criteria:</p><ol><li>Any concurrent therapy with other investigational, chemotherapeutic, or hormonal therapy.</li><li>Prior treatment with &gt;=3 regimens of cytotoxic therapy in the advanced disease setting.
(Any number of previous hormonal therapies are acceptable, as long as the therapy is discontinued prior to the patient&#x27;s enrollment into this study).</li><li>Major surgery or systemic therapy &lt;=3 weeks of study treatment.</li><li>Prior high-dose chemotherapy requiring hematopoietic stem cell support.</li><li>Prior radiation therapy to &gt;25% of the bone marrow.</li><li>Uncontrolled brain metastases.
Patients with treated brain metastases (resection or radiotherapy) are eligible if brain metastases have responded to treatment as documented by CT or MRI scan obtained at &gt;=2 weeks after completion of radiation therapy, neurologic symptoms are absent, and steroids have been discontinued.</li><li>Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis.</li><li>Diagnosis of second malignancy within the last 3 years (with the exception of carcinoma in situ of the cervix, squamous or basal cell skin cancer, thyroid cancer, ductal carcinoma in situ [DCIS], or lobular carcinoma in situ [LCIS]).</li><li><p>Any of the following &lt;=12 months prior to starting study treatment:</p><ul><li>myocardial infarction;</li><li>severe unstable angina;</li><li>congestive heart failure;</li><li>ongoing cardiac dysrhythmia.</li></ul></li><li>Family history of idiopathic cardiomyopathy or uncontrolled heart arrhythmia.</li><li>Patients with previous allergy or hypersensitivity to anthracyclines.</li><li>Palliative radiotherapy to areas of metastatic breast cancer must have been completed &gt;7 days prior to the first dose of study treatment.
The exception is radiotherapy for brain metastases, which must be completed &gt;=21 days prior to study treatment.
(Note: Any measurable lesion that has been previously irradiated will not be considered as a target lesion).</li><li>Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness&#x2F;social situations that would limit compliance with study requirements.</li><li>History of seropositive HIV, or patients who are receiving immunosuppressive medications that increase the risk of neutropenic complications.</li><li>Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.</li><li>Use of any non-approved or investigational agent &lt;=30 days of administration of the first dose of study drug.
Patients may not receive any other investigational or anti-cancer treatments while participating in this study.</li></ol>

After

<p>Inclusion Criteria:</p><ol><li>Females &gt;=18 years of age.</li><li><p>Histologic diagnosis of HER2-negative breast cancer.
HER-2 negativity must be confirmed by one of the following:</p><ul><li>FISH-negative (FISH ratio &lt;2.2), or</li><li>IHC 0-1+, or</li><li>IHC 2-3+ AND FISH-negative (FISH ratio &lt;2.2)</li></ul></li><li>Evidence of metastatic or locally advanced, inoperable breast cancer.</li><li>Minimum of 1 and maximum of 2 prior metastatic breast cancer chemotherapy regimens.</li><li>Patients with prior anthracycline therapy are eligible, provided their previous anthracycline was ≥6 months prior to study entry.</li><li>Measurable disease per RECIST criteria version 1.1</li><li>Left ventricular ejection fraction (LVEF) ³50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).</li><li>Patients must have QTc interval of &lt;=450 msec.</li><li>No intercurrent significant medical conditions or cardiac illness.</li><li>Patients must be &gt;=3 weeks since last chemotherapy, and recovered from all acute toxicities, with the exception of alopecia.</li><li>Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2.</li><li><p>Adequate organ function including the following:</p><ul><li>ANC &gt;=1500 cells&#x2F;mL</li><li>Platelet count &gt;=100,000 cells&#x2F;mL</li><li>Hemoglobin &gt;=9 g&#x2F;dL</li><li>Total bilirubin &lt;=1.5 x ULN; AST&#x2F;ALT &lt;=2.5 x ULN, (except if due to hepatic metastases, then &lt;=5 x ULN)</li><li>Serum creatinine &lt;1.5 x ULN</li></ul></li><li>Women of childbearing potential must have a negative serum or urine pregnancy test performed &lt;=7 days prior to start of treatment.
If a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.</li><li>Patients must be accessible for treatment and follow-up.</li><li>Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.</li><li>Patients who are on anticoagulation are acceptable if the therapeutic anticoagulation is stable.
Additionally, the patient&#x27;s INR must be adequate if the patient is receiving treatment with coumadin.</li><li>Prior hormonal therapy for metastatic breast cancer is permitted; however, the therapy must be discontinued prior to the patient&#x27;s enrollment in this study.</li></ol><p>Exclusion Criteria:</p><ol><li>Any concurrent therapy with other investigational, chemotherapeutic, or hormonal therapy.</li><li>Prior treatment with &gt;=3 regimens of cytotoxic therapy in the advanced disease setting.
(Any number of previous hormonal therapies are acceptable, as long as the therapy is discontinued prior to the patient&#x27;s enrollment into this study).</li><li>Major surgery or systemic therapy &lt;=3 weeks of study treatment.</li><li>Prior high-dose chemotherapy requiring hematopoietic stem cell support.</li><li>Prior radiation therapy to &gt;25% of the bone marrow.</li><li>Uncontrolled brain metastases.
Patients with treated brain metastases (resection or radiotherapy) are eligible if brain metastases have responded to treatment as documented by CT or MRI scan obtained at &gt;=2 weeks after completion of radiation therapy, neurologic symptoms are absent, and steroids have been discontinued.</li><li>Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis.</li><li>Diagnosis of second malignancy within the last 3 years (with the exception of carcinoma in situ of the cervix, squamous or basal cell skin cancer, thyroid cancer, ductal carcinoma in situ [DCIS], or lobular carcinoma in situ [LCIS]).</li><li><p>Any of the following &lt;=12 months prior to starting study treatment:</p><ul><li>myocardial infarction;</li><li>severe unstable angina;</li><li>congestive heart failure;</li><li>ongoing cardiac dysrhythmia.</li></ul></li><li>Family history of idiopathic cardiomyopathy or uncontrolled heart arrhythmia.</li><li>Patients with previous allergy or hypersensitivity to anthracyclines.</li><li>Patients who have had a ≥10% drop in LVEF on previous anthracycline therapy.</li><li>Palliative radiotherapy to areas of metastatic breast cancer must have been completed &gt;7 days prior to the first dose of study treatment.
The exception is radiotherapy for brain metastases, which must be completed &gt;=21 days prior to study treatment.
(Note: Any measurable lesion that has been previously irradiated will not be considered as a target lesion).</li><li>Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness&#x2F;social situations that would limit compliance with study requirements.</li><li>History of seropositive HIV, or patients who are receiving immunosuppressive medications that increase the risk of neutropenic complications.</li><li>Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.</li><li>Use of any non-approved or investigational agent &lt;=30 days of administration of the first dose of study drug.
Patients may not receive any other investigational or anti-cancer treatments while participating in this study.</li></ol>

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

2009-12-30

After

2010-06-29

replace /protocolSection/statusModule/lastUpdatePostDateStruct/date

Triage: Uncategorized

Uncategorized Operation 2

Before

2010-01-01

After

2010-06-30

Raw JSON Patch

[
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdateSubmitDate",
    "value": "2010-06-29"
  },
  {
    "op": "replace",
    "path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
    "value": "2010-06-30"
  },
  {
    "op": "replace",
    "path": "/protocolSection/eligibilityModule/eligibilityCriteria",
    "value": "<p>Inclusion Criteria:</p><ol><li>Females &gt;=18 years of age.</li><li><p>Histologic diagnosis of HER2-negative breast cancer.\nHER-2 negativity must be confirmed by one of the following:</p><ul><li>FISH-negative (FISH ratio &lt;2.2), or</li><li>IHC 0-1+, or</li><li>IHC 2-3+ AND FISH-negative (FISH ratio &lt;2.2)</li></ul></li><li>Evidence of metastatic or locally advanced, inoperable breast cancer.</li><li>Minimum of 1 and maximum of 2 prior metastatic breast cancer chemotherapy regimens.</li><li>Patients with prior anthracycline therapy are eligible, provided their previous anthracycline was ≥6 months prior to study entry.</li><li>Measurable disease per RECIST criteria version 1.1</li><li>Left ventricular ejection fraction (LVEF) ³50% by echocardiogram (ECHO) or multiple gated acquisition scan (MUGA).</li><li>Patients must have QTc interval of &lt;=450 msec.</li><li>No intercurrent significant medical conditions or cardiac illness.</li><li>Patients must be &gt;=3 weeks since last chemotherapy, and recovered from all acute toxicities, with the exception of alopecia.</li><li>Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2.</li><li><p>Adequate organ function including the following:</p><ul><li>ANC &gt;=1500 cells&#x2F;mL</li><li>Platelet count &gt;=100,000 cells&#x2F;mL</li><li>Hemoglobin &gt;=9 g&#x2F;dL</li><li>Total bilirubin &lt;=1.5 x ULN; AST&#x2F;ALT &lt;=2.5 x ULN, (except if due to hepatic metastases, then &lt;=5 x ULN)</li><li>Serum creatinine &lt;1.5 x ULN</li></ul></li><li>Women of childbearing potential must have a negative serum or urine pregnancy test performed &lt;=7 days prior to start of treatment.\nIf a woman becomes pregnant or suspects she is pregnant while participating in this study, she must agree to inform her treating physician immediately.</li><li>Patients must be accessible for treatment and follow-up.</li><li>Patients must be able to understand the investigational nature of this study and give written informed consent prior to study entry.</li><li>Patients who are on anticoagulation are acceptable if the therapeutic anticoagulation is stable.\nAdditionally, the patient&#x27;s INR must be adequate if the patient is receiving treatment with coumadin.</li><li>Prior hormonal therapy for metastatic breast cancer is permitted; however, the therapy must be discontinued prior to the patient&#x27;s enrollment in this study.</li></ol><p>Exclusion Criteria:</p><ol><li>Any concurrent therapy with other investigational, chemotherapeutic, or hormonal therapy.</li><li>Prior treatment with &gt;=3 regimens of cytotoxic therapy in the advanced disease setting.\n(Any number of previous hormonal therapies are acceptable, as long as the therapy is discontinued prior to the patient&#x27;s enrollment into this study).</li><li>Major surgery or systemic therapy &lt;=3 weeks of study treatment.</li><li>Prior high-dose chemotherapy requiring hematopoietic stem cell support.</li><li>Prior radiation therapy to &gt;25% of the bone marrow.</li><li>Uncontrolled brain metastases.\nPatients with treated brain metastases (resection or radiotherapy) are eligible if brain metastases have responded to treatment as documented by CT or MRI scan obtained at &gt;=2 weeks after completion of radiation therapy, neurologic symptoms are absent, and steroids have been discontinued.</li><li>Suspected, diffuse idiopathic interstitial lung disease or pulmonary fibrosis.</li><li>Diagnosis of second malignancy within the last 3 years (with the exception of carcinoma in situ of the cervix, squamous or basal cell skin cancer, thyroid cancer, ductal carcinoma in situ [DCIS], or lobular carcinoma in situ [LCIS]).</li><li><p>Any of the following &lt;=12 months prior to starting study treatment:</p><ul><li>myocardial infarction;</li><li>severe unstable angina;</li><li>congestive heart failure;</li><li>ongoing cardiac dysrhythmia.</li></ul></li><li>Family history of idiopathic cardiomyopathy or uncontrolled heart arrhythmia.</li><li>Patients with previous allergy or hypersensitivity to anthracyclines.</li><li>Patients who have had a ≥10% drop in LVEF on previous anthracycline therapy.</li><li>Palliative radiotherapy to areas of metastatic breast cancer must have been completed &gt;7 days prior to the first dose of study treatment.\nThe exception is radiotherapy for brain metastases, which must be completed &gt;=21 days prior to study treatment.\n(Note: Any measurable lesion that has been previously irradiated will not be considered as a target lesion).</li><li>Concurrent severe, intercurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness&#x2F;social situations that would limit compliance with study requirements.</li><li>History of seropositive HIV, or patients who are receiving immunosuppressive medications that increase the risk of neutropenic complications.</li><li>Mental condition that would prevent patient comprehension of the nature of, and risk associated with, the study.</li><li>Use of any non-approved or investigational agent &lt;=30 days of administration of the first dose of study drug.\nPatients may not receive any other investigational or anti-cancer treatments while participating in this study.</li></ol>"
  }
]