Eligibility Breast Cancer N1131 3233760v1.0 N1131 Eligibility Checklist Source Form: NCI FormBuilder:


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August 5, 2015

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Eligibility Breast Cancer N1131 3233760v1.0

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  1. StudyEvent: N1131 Eligibility Checklist
    1. No Instruction available.
Required Characteristics
18 Years and older
Histologically or cytologically confirmed estrogen receptor positive (ER+) (defined as >1% staining) adenocarcinoma of the breast with clinical evidence of metastatic disease
Pre-treatment requirements:a.<=2 prior hormonal treatments in any settingNote: For premenopausal patients prior therapy must have included tamoxifen.Note: For postmenopausal patients prior therapy must have included an aromatase inhibitor (AI).b.No prior chemotherapy for metastatic disease.Note: Prior chemotherapy allowed in neoadjuvant and/or adjuvant setting only.c.No prior lung radiation therapy.Note: Chest wall radiation for breast cancer is allowed.
Measurable disease as defined in Section 11.0
Adequate pulmonary function: normal DLCO or the presence of an asymptomatic Grade 1 DLCO per grading criteria found in Appendix III (NOTE: DLCO must be corrected for hemoglobin.)
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. If not a woman of childbearing potential or male (check NA)
The following laboratory values obtained <=15 days prior to registration
Hemoglobin >=9.0 g/dL
Absolute neutrophil count (ANC) >=1500/mm3
Peripheral platelet count (PLT) >=100,000/mm3
Total bilirubin <=1.5 x upper limit of normal (ULN)
Alkaline phosphatase <=2.5 x ULN or alkaline phosphatase <=5 x ULN if elevations are due to liver metastases
Is there liver metastatic involvement (This question may be answered yes or no)
SGOT (AST) and SGPT (ALT) <=3 x ULN or SGOT (AST) and SGPT (ALT) <=5 x ULN if elevations are due to liver metastases
Serum creatinine <=1.5 x ULN; if >1.25 x ULN calculated creatinine clearance must be >=60 ml/min
Is Serum creatinine >1.25 x ULN
ECOG performance status (PS) 0, 1, or 2
ECOG Performance Status
Life expectancy >3 months
Willingness to return to NCCTG enrolling institution for treatment and follow-up
Willing to provide tissue and blood samples for correlative research purposes (see Sections 6.0, 14.0 and 17.0)
Provide informed written consent
Exclusion Criteria
Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
Prior thoracic radiotherapy. Note: Chest wall radiotherapy for breast cancer is allowed
Symptomatic pulmonary disease
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Chemotherapy <=3 weeks prior to study entry (Any of the following prior therapies: If no prior chemotherapy check NA)
Mitomycin C/nitrosoureas <=6 weeks prior to study entry (If no prior mitomycin C/nitrosoureas check NA)
Immunotherapy <=3 weeks prior to study entry (If no prior immunotherapy check NA)
Biologic therapy <=3 weeks prior to study entry (If no prior biologic therapy check NA)
Radiation therapy <=3 weeks prior to study entry (If no prior radiation therapy check NA)
Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
Uncontrolled brain metastases including patients who continue to require glucocorticoids for brain or leptomeningeal metastases (Note: Patients with CNS metastases that are stable for at least 8 weeks prior to registration based on imaging, clinical assessment, and use of steroids are eligible.)
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown. - Pregnant women - Nursing women - Men or women of childbearing potential who are unwilling to employ adequate contraception (as determined by the treating physician) while on this study and for 30 days after end of treatment with the study drugs
History of allergy or hypersensitivity to agents chemically similar to AFP464
Active smokers and those who have smoked <=30 days prior to registration, and patients unwilling or unable to completely refrain from smoking while on study
New York Heart Association class III or IV cardiovascular disease
Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of the safety and adverse events of the prescribed regimens
Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive
Other active malignancy <=3 years prior to registration. EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix. NOTE: If there is a history of prior malignancy, they must not be receiving other specific treatment (other than hormonal therapy) for their cancer
Pre-registration Check
Consent form signed and dated
Authorization for use and disclosure of protected health information signed and dated (U.S.A, institutions only If not a USA institution check NA)
A mandatory translational research component is part of this study, patients will automatically be registered to the translational research component of this study at the time of registration. (see Sections 3 and 17)
Treatment cannot begin prior to registration and must begin <=14 days after registration
Pretreatment tests/procedures must be completed <=15 days prior to registration (see Section 4.0)
All required baseline symptoms (see Section 10.3) must be documented and graded
Treatment on this protocol must commence at an NCCTG institution under the supervision of an NCCTG member physician
Blood draw kit is available on site (for this patient)
An optional correlative research component is part of this study, there will be an option to select if the patient is to be registered onto this component (see Section 14)
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat cancer
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat other health problems (for example: diabetes, Alzheimer's disease, or heart disease)
Patient has given permission for NCCTG to give his/her sample(s) to outside researchers
Patient has agreed to be enrolled on N0392 (NOTE: N0392 must be open to site and offered to patient. At time of registration, willingness to participate will be recorded.)
Treatment Decision
Subgroup Code
Assigned Treatment