Breast Cancer NCT00684983 Eligibility - NCCTG N0733 Eligibility Checklist - 2777789v1.0 NCCTG N0733 Eligibility Checklist Capecitabine and Lapatinib With or Without Cixutumumab in Treating Patients With Previously Treated HER2-Positive Stage IIIB, Stage IIIC, or Stage IV Breast Cancer Source Form: NCI FormBuilder:

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September 20, 2021

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Eligibility Breast Cancer NCCTG N0733 NCT00684983

First 10 patients only: Prior to discussing this protocol with the patient call the CTSU office 1-888-462-3009 to see if there is a place available for your patient.

Patient Demographics / Pre-treatment Characteristics
Ethnicity (U.S. and Canada only)
Country of residence
Method of Payment (check oneUSA only)
Pre-treatment Requirements
Age 18 Years and older
Histologically confirmed, locally advanced (a T4 primary tumor and stage IIIB or IIIC disease) or metastatic breast cancer that has progressed after treatment with regimens that included trastuzumab and either an anthracycline or a taxane or both. (NOTE: Agents need not have been given concurrently nor in the same regimen. NOTE: Prior treatment with trastuzumab is required unless there is a contraindication for trastuzumab treatment.)
Prior treatment with trastuzumab in the neo-adjuvant, adjuvant, or metastatic setting is required. (NOTE: Prior treatment with trastuzumab is required unless there is a contraindication for trastuzumab treatment. - NOTE: Concomitant use of trastuzumab is not allowed in this study.)
Prior chemotherapy allowed in the neo-adjuvant, adjuvant, or metastatic setting. Unlimited prior chemotherapy is allowed.
Prior hormonal therapy allowed in the neo-adjuvant, adjuvant, or metastatic setting. Unlimited prior hormonal therapy is allowed.
HER2 positive, defined as: Validated IHC assay score of 3+ (defined as uniform, intense staining of >30% of invasive tumor cells) -OR- Average HER2 gene copy number of >6 -OR- Gene amplified (HER2:D17Z1) ratio >2.20
Must have measurable disease according to RECIST criteria (See Section 11.0)
Negative pregnancy test done <=7 days prior to registration, for women of childbearing potential only. (If not a woman of childbearing potential check NA)
The following laboratory values obtained <=7 days prior to registration
Hemoglobin >9.0 g/dL
WBC >= 3,000/mL
ANC >= 1500/mL
Platelet Count >= 75,000/mL
Total bilirubin <= 1.5 x ULN
SGOT(AST) and SGPT(ALT) <=2.5 x ULN or SGOT(AST) and SGPT(ALT) <5 x ULN if elevations are due to liver metastases.
SGOT(AST) and SGPT(ALT) >2.5 x ULN due to liver metastases (This question may be answered "Yes" or "No")
Serum Creatinine <=1.5 x ULN
Creatinine clearance >=30 mL/min (calculated according to Cockcroft and Gault - see Appendix II)
Fasting glucose <120 mg/dL (NOTE: Patients with diabetes are allowed to participate, provided that their blood glucose is within the guidelines above upon enrollment.)
International Normalization Ratio (INR) <= 1.5 X ULN
ECOG performance status 0, 1, or 2
Performance Status
Adequate cardiac function as defined as an ejection fraction 50% as determined by MUGA or echocardiogram
Life expectancy >3 months
Has written informed consent been obtained
Willingness to return to an NCCTG or other participating cooperative group institution for treatment and follow-up
Patient willing to provide tissue and blood samples for research purposes (see Sections 6.0 14.0 and 17.0)
Availability of diagnostic material (i.e., diagnostic slides confirming locally advanced/metastatic disease and HER2 stained slides) and operative and pathology reports from diagnosis of locally advanced or metastatic breast cancer (NOTE: Biopsy of recurrent disease and submission of these materials is not required if materials available from initial diagnosis of locally advanced/metastatic disease.)
Ability to complete questionnaire(s) by themselves or with assistance (All responses in above section must be "Yes" unless specified as "NA.")
Exclusion Criteria
Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus 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).
Stage III or IV invasive cancer, other than breast cancer, in <=5 years prior to registration.
Actively being treated for other malignancy, excepting non-melanotic skin cancer or carcinoma-in-situ of the cervix (If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.)
New York Heart Association class III or IV cardiovascular disease
Current, active hepatic or biliary disease except Gilbert's syndrome or asymptomatic gallstones
Evidence of active brain metastasis including leptomeningeal involvement. CNS metastasis controlled by prior surgery and/or radiotherapy is allowed. (NOTE: To be considered controlled, there must be at least 2 months of no symptoms or evidence of progression prior to study entry and corticosteriod therapy must have been discontinued.)
Major surgery, chemotherapy, or immunologic therapy <=6 weeks prior to registration
Radiotherapy <=4 weeks prior to registration, except if to a non-target lesion only. Prior radiation to a target lesion is permitted only if there has been clear progression of the lesion since radiation was completed. (If patient receives single dose radiation for palliation or radiation to non-target lesion, they may immediately proceed to registration without waiting 4 weeks. Acute adverse events from radiation must have resolved to <=CTCAE v3.0 Grade 1.)
Prior treatment with any therapy targeting IGF-I, IGF-II or its receptors(either monoclonal antibody or tyrosine kinase inhibitor), including but not limited to any of the following (which would have been received on a previous clinical trial): - IMC-A12 (cixutumumab) - CP-751,871 (figitumumab) - AMG-479 - INSM-18 - MK0646 (h7C10) - SCH717454 (19D12, robatumumab) - R1507 - OSI-906 - BMS-754807 - PPP - NVP-AEW541 - AVE-1642 - MEDI-573
Prior therapy with any therapy targeting HER1 (EGFR) and/or HER2 (either monoclonal antibody or tyrosine kinase) other than trastuzumab, including but not limited to any of the following: (lapatinib Tykerb, gefitinib Iressa, erlotinib Tarveca, cetuximab Erbitux, panitumumab Vectibix)
Currently receiving treatment with any agents that are contraindicated by study therapies: A) IMC-A12 - none identified to date B) Lapatinib - CYPA34 inhibitors and inducers (see Appendix IV) including grapefruit and grapefruit juice (C Capecitabine - warfarinCoumadin, cimetidineTagamet, allopurinolLopurin, sorivudineUsevir, brivudineBrivex, ketoconazoleNizoral, itraconazoleSporanox, ritonavirNorvir, amprenavirAgenerase, or indinavirCrixivan)
Uncontrolled intercurrent illness (including, but not limited to: - Poorly controlled diabetes - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Psychiatric illness/social situations that would limit compliance with study requirements)
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 (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 with an AIDS-defining illness. (HIV positive patients with CD4 count within institutional normal range and no history of an AIDS-defining illness are eligible, however, some antiviral/antiretroviral medications which have CYP3A4 interactions are prohibited on this study.)
Registration Check
Consent form signed and dated
Authorization for use and disclosure of protected health information signed and dated (Non-USA institution only 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 Section 14.0 and 17.0)
Treatment cannot begin prior to registration and must begin <=7 days after registration
Pretreatment tests/procedures must be completed <= 7 days prior to registration (NOTE: The earliest pretreatment test/procedure date must be less than or equal to the earliest laboratory test/procedure date and the latest pretreatment test/procedure date must be greater than or equal to the latest laboratory test/procedure date.)
All required baseline symptoms (see Section 10.3) must be documented and graded
Study drug availability checked (Study drug must be in site pharmacy for this patient prior to registration)
Blood draw kit availability checked (Site must have a kit on hand for this patient prior to registration)
This protocol has a mandatory quality assurance (QA) audit submission of diagnostic slides and HER2 stained slides used to make a HER2 positive metastatic breast cancer diagnosis, plus corresponding operating and pathology reports (If these materials are not available, the patient is not eligible for this trial)
Patient QOL booklet availability checked; copies are not acceptable for this submission (Site must have booklets on hand for this patient prior to registration)
This protocol has mandatory monitoring for the Safety Cohort - sites must participate in monthly conference calls (see Section 16.8.4)
At The Time Of Registration/randomization, The Following Will Also Be Recorded:
Patient has given permission to keep sample(s) for use in future research to learn about, prevent, or treat cancer
Patient has given permission to keep 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 NCCTG permission to give sample(s) to outside researchers
Stratification Factors
Receptor Status (Hormone)
Number of prior chemotherapy regimens in the metastatic setting
Subgroup Code

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