Eligibility Breast Cancer N1131 3233760v1.0 Required Characteristics Exclusion Criteria Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy Yes
No
Prior thoracic radiotherapy. Note: Chest wall radiotherapy for breast cancer is allowed Yes
No
Symptomatic pulmonary disease Yes
No
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 Yes
No
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 Yes
No
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.) Yes
No
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 Yes
No
History of allergy or hypersensitivity to agents chemically similar to AFP464 Yes
No
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 Yes
No
New York Heart Association class III or IV cardiovascular disease Yes
No
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 Yes
No
Currently receiving treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered Yes
No
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive Yes
No
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 Yes
No
Pre-registration Check Consent form signed and dated Yes
No
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) Yes
No
Treatment cannot begin prior to registration and must begin <=14 days after registration Yes
No
Pretreatment tests/procedures must be completed <=15 days prior to registration (see Section 4.0) Yes
No
All required baseline symptoms (see Section 10.3) must be documented and graded Yes
No
Treatment on this protocol must commence at an NCCTG institution under the supervision of an NCCTG member physician Yes
No
Blood draw kit is available on site (for this patient) Yes
No
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) Yes
No
Patient has given permission to store and use his/her sample(s) for use in future research to learn about, prevent, or treat cancer Yes
No
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) Yes
No
Patient has given permission for NCCTG to give his/her sample(s) to outside researchers Yes
No
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.) Yes
No
Treatment Decision Subgroup Code Assigned Treatment 
