Description:

Eligibility Breast Cancer Panobinostat and Letrozole NCT01105312 N093B 3303518v1.0 Breast Cancer NCT01105312 Eligibility - NCCTG Eligibility Checklist N093B - 3303518v1.0 NCCTG Eligibility Checklist N093B Panobinostat and Letrozole in Treating Patients With Metastatic Breast Cancer Source Form: NCI FormBuilder: https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1C93F5C-1300-C2C0-E040-BB89AD4348C9

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https://formbuilder.nci.nih.gov/FormBuilder/formDetailsAction.do?method=getFormDetails&formIdSeq=B1C93F5C-1300-C2C0-E040-BB89AD4348C9

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Versions (4) ▾
  1. 8/27/12
  2. 7/10/15
  3. 9/24/15
  4. 9/20/21
Uploaded on:

September 20, 2021

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Creative Commons BY-NC 3.0 Legacy
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Eligibility Breast Cancer Panobinostat and Letrozole NCT01105312 N093B 3303518v1.0

Details

No Instruction available.

  1. StudyEvent: NCCTG Eligibility Checklist N093B
    1. No Instruction available.
Pre-treatment Requirements
Age >= 18 years
Histologic proof of metastatic breast cancer that is unresected at registration (with no intention of resecting tumors during this study). Evidence of metastatic breast cancer confirmed by radiological imaging
Measurable disease (see Section 11.21 for definition of measurable disease)
Metastatic site(s) must be amenable to biopsy
Post-menopausal according to any one of the following criteria: a. Age >60 years old b. Age >45 years old with last menstrual period >12 months prior to registration and estriadiol and folliclestimulating hormone (FSH) levels in postmenopausal range (per institutional normal limits) c. Bilateral oophorectomy If male (check NA).
Tumor estrogen, progesterone and HER2 [tested by IHC or FISH (fluorescent in situ hybridization)] status from the metastatic site. If not available, the results from the original tumor diagnosing the primary breast cancer may be used.- Triple negative disease only [ER- (defined as =<1% by IHC), PR- (defined as =<1% by IHC), and HER2-] Patients with triple negative breast cancer are allowed if there is clinical or radiographic evidence of tumor progression in the adjuvant or metastatic setting. (Note: If HER2 result by IHC is 2+ equivocal, the tumor must be confirmed to be HER2- by FISH.)
Prior treatments allowed: 0 or 1 prior chemotherapy regimens for breast cancer. <=2 prior aromatase inhibitor regimens (including letrozole)
The following laboratory values obtained <= 14 days prior to registration
ANC >= 1,500/mm^3
1000/ul
Platelet count >= 100,000/mm^3
1000/uL
Total bilirubin =< upper limit of normal (ULN)
mg/dL
mg/dL
SGPT (ALT) <=3 x ULN or SGPT (ALT) <=5 x ULN if elevations are due to liver metastasis
Is there liver involvement
SGOT (AST) <=3 x ULN or SGOT (AST) <=5 x ULN if elevations are due to liver metastasis
U/L
TSH <= ULN
Creatinine <= 1.5 x ULN
mg/dL
mg/dL
ECOG performance status (PS) 0, 1, or 2
ECOG performance status grade
Ability to provide informed written consent
Willing to return to NCCTG enrolling institution for follow-up
Life expectancy >=12 weeks
Willing to provide tissue samples for correlative research purposes (see Sections 4.0, 6.25, and 17.1)
Exclusion Criteria - All Responses In Section Below Must Be "no."
Known standard therapy for the patient's disease that is potentially curative or definitely capable of extending life expectancy
>1prior chemotherapy regimen for breast cancer. >2 prior aromatase inhibitor regimens
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 <=4 weeks prior to registration (Any of the following prior therapies: If no prior chemotherapy check NA)
Radiation therapy <=4 weeks prior to registration (If no prior radiation therapy check NA)
Radiation to >25% of bone marrow
Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
New York Heart Association class III or IV cardiovascular disease
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)
Receiving any other investigational agent concurrently which would be considered as a treatment for the primary neoplasm
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 safety and toxicity of the prescribed regimens
Immunocompromised patients (other than that related to the use of corticosteroids) including patients known to be HIV positive
History of other malignancy <=5 years with the exception of non-melanoma skin cancer or carcinoma in-situ of the cervix
History of myocardial infarction or unstable angina <=6 months prior to registration or congestive heart failure (CHF) requiring use of ongoing maintenance therapy, or life-threatening ventricular arrhythmias
Receiving CYP3A4 inhibitors and inducers or any other contraindicated agent listed in Appendix III
Congenital long QT syndrome or QTcF>450 msec on screening ECG:- Complete left bundle block or use of a permanent cardiac pacemaker, history or presence of ventricular tachyarrhythmias, clinically significant resting bradycardia (<50 beats per minute)- Right bundle branch block + left anterior hemiblock (bifascicular block
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 correlative research component is part of this study for all patients, the patient will be automatically registered onto this component (see Section 3.19c, 4.0 and/or 17.1)
Treatment on this protocol must commence at the accruing membership under the supervision of an NCCTG member physician
Treatment cannot begin prior to registration and must begin <=14 days after registration
Pretreatment tests/procedures must be completed <= 14 days prior to registration (see Section 4.0 - 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
Blood draw kit availability checked (Blood kit must be available on site)
Patient has given permission to give his/her blood sample for research testing
Patient has given permission to store and use his/her blood/plasma sample for future research to learn about, prevent, or treat cancer
Patient has given permission to store and use his/her blood/plasma sample 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 blood to outside researchers
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 tissue(s) sample 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 tissue(s) to outside researchers
Is this an NCCTG institution (NCCTG Institutions only: N0932 must be open at site and offered to patient. - This question may be answered yes or no.)
Patient has agreed to be enrolled on N0932 (At time of registration, the following will be recorded:)
Grouping Factor (Patient Cohort)
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