Age | Secondary malignant neoplasm of female breast Estrogen receptor positive | Disease Progression | Stable Disease Radiography | TUMOR MARKER LEVEL ELEVATED | Hormone Therapy | Progression-Free Survival
Item
1. patients ≥ 18 years of age with histologically confirmed, metastatic er + breast cancer with clinical progression of disease (including radiographically stable disease with at least 50% increment of an elevated tumor marker by two measurements at least 2 weeks apart (this particular tumor marker will be used for disease status assessment in the study) on current hormonal therapy with pfs for at least 3 months.
boolean
C0001779 (UMLS CUI [1])
C0346993 (UMLS CUI [2,1])
C0279754 (UMLS CUI [2,2])
C0242656 (UMLS CUI [3])
C0677946 (UMLS CUI [4,1])
C0034571 (UMLS CUI [4,2])
C0749735 (UMLS CUI [5])
C0279025 (UMLS CUI [6])
C0242792 (UMLS CUI [7])
Karnofsky Performance Status | Life Expectancy
Item
2. karnofsky performance status (kps) ≥70% and a life expectancy >3 months.
boolean
C0206065 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
Target Lesion Visceral Quantity | Evaluation Tumor Response | Secondary malignant neoplasm of bone Imaging study Positive | Bone scan | Magnetic Resonance Imaging | PET/CT scan | CT | Tumour marker increased
Item
3. participants must have at least one target visceral lesion that allows for evaluation of tumor response or in the case of bone-only metastases, patients need to have a positive imaging study such as bone scan, magnetic resonance imaging (mri) or positron emission tomography-computed tomography (pet-ct) or ct, and an elevated tumor marker at least twice as high as upper limit.
boolean
C2986546 (UMLS CUI [1,1])
C0442045 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1261322 (UMLS CUI [2,1])
C0027651 (UMLS CUI [2,2])
C1704632 (UMLS CUI [2,3])
C0153690 (UMLS CUI [3,1])
C1881134 (UMLS CUI [3,2])
C1514241 (UMLS CUI [3,3])
C0203668 (UMLS CUI [4])
C0024485 (UMLS CUI [5])
C1699633 (UMLS CUI [6])
C0040405 (UMLS CUI [7])
C0876999 (UMLS CUI [8])
Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
4. absolute neutrophil count > 1500 mm3, platelet count ≥ 80×109 l, hemoglobin ≥ 8.5 g/dl
boolean
C0948762 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
C0518015 (UMLS CUI [3])
Creatinine clearance measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
5. creatinine clearance ≥ 30 ml/min, total bilirubin ≤ 2 mg/dl, ast/alt ≤ 3 times the upper limit of normal range
boolean
C0373595 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
Absence Toxicity Remaining CTCAE Grades | Cancer treatment Previous
Item
6. no remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the principal investigator
boolean
C0332197 (UMLS CUI [1,1])
C0600688 (UMLS CUI [1,2])
C1527428 (UMLS CUI [1,3])
C1516728 (UMLS CUI [1,4])
C0920425 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
Major surgery
Item
7. at least two (2) weeks from prior major surgery
boolean
C0679637 (UMLS CUI [1])
Permission Biopsy lesion | Permission Collection of blood specimen for laboratory procedure
Item
8. willingness to provide permission to biopsy one of the lesions if applicable before the study (all the patients are encouraged to have post-therapy biopsy upon progression of disease, but it is optional) as well as blood samples for pertinent laboratory studies
boolean
C0521104 (UMLS CUI [1,1])
C0940828 (UMLS CUI [1,2])
C0521104 (UMLS CUI [2,1])
C0005834 (UMLS CUI [2,2])
Childbearing Potential Contraceptive methods | Premenopausal state | Female Sterilization | Sexual Abstinence | Barrier Contraception Double | Childbearing Potential Urine pregnancy test negative | Childbearing Potential Serum pregnancy test negative
Item
9. women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable non-hormonal contraceptive method (abstinence, or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial -
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0232969 (UMLS CUI [2])
C0015787 (UMLS CUI [3])
C0036899 (UMLS CUI [4])
C0004764 (UMLS CUI [5,1])
C0205173 (UMLS CUI [5,2])
C3831118 (UMLS CUI [6,1])
C0430057 (UMLS CUI [6,2])
C3831118 (UMLS CUI [7,1])
C0430061 (UMLS CUI [7,2])
Combined Modality Therapy | Hormone Therapy | everolimus | Investigational New Drugs
Item
1. on combination hormonal therapy with everolimus or any other investigational agent
boolean
C0009429 (UMLS CUI [1])
C0279025 (UMLS CUI [2])
C0541315 (UMLS CUI [3])
C0013230 (UMLS CUI [4])
Metastatic malignant neoplasm to brain Symptomatic Untreated | Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic Untreated | Metastatic malignant neoplasm to brain Symptomatic Treated | Metastatic Malignant Neoplasm to the Leptomeninges Symptomatic Treated | Steroids Required
Item
2. patients have symptomatic untreated brain metastasis or leptomeningeal metastases or treated but still symptomatic requiring the use of steroid 18jul2014 protocol v3: abc 01 anti-autophagy for met breast cancer page 4 of 16
boolean
C0220650 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0332155 (UMLS CUI [1,3])
C1704231 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0332155 (UMLS CUI [2,3])
C0220650 (UMLS CUI [3,1])
C0231220 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1704231 (UMLS CUI [4,1])
C0231220 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C0038317 (UMLS CUI [5,1])
C1514873 (UMLS CUI [5,2])
Lymphangitis carcinomatosa Involving Lung Percentage | Neoplasm Metastasis Involving Liver Third | Ultrasonography | Computed Tomography
Item
3. lymphangitic carcinomatosis involving ≥ 50% of the lungs; evidence of metastases involving more than one third of the liver on sonogram or computed tomography
boolean
C0238258 (UMLS CUI [1,1])
C1314939 (UMLS CUI [1,2])
C0024109 (UMLS CUI [1,3])
C0439165 (UMLS CUI [1,4])
C0027627 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0023884 (UMLS CUI [2,3])
C0442047 (UMLS CUI [2,4])
C0041618 (UMLS CUI [3])
C0040405 (UMLS CUI [4])
Breast Feeding
Item
4. lactating females
boolean
C0006147 (UMLS CUI [1])
Heart Disease Uncontrolled | Congestive heart failure | Angina Pectoris | Hypertensive disease
Item
5. uncontrolled cardiac disease, congestive heart failure, angina or hypertension
boolean
C0018799 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0018802 (UMLS CUI [2])
C0002962 (UMLS CUI [3])
C0020538 (UMLS CUI [4])
Myocardial Infarction | Angina, Unstable
Item
6. myocardial infarction or unstable angina within 2 months of treatment
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
HIV Infection | Hepatitis B, Chronic | Hepatitis C, Chronic
Item
7. known human immunodeficiency virus (hiv) infection or chronic active hepatitis b or c (patients are not required to be tested for the presence of such viruses prior to therapy on this protocol)
boolean
C0019693 (UMLS CUI [1])
C0524909 (UMLS CUI [2])
C0524910 (UMLS CUI [3])
Communicable Disease Serious CTCAE Grades
Item
8. active clinically serious infection > ctcae (version 4.03) grade 2
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C1516728 (UMLS CUI [1,3])
Wound, non-healed | Ulcer | Fracture
Item
9. serious non-healing wound, ulcer, or bone fracture
boolean
C0750433 (UMLS CUI [1])
C0041582 (UMLS CUI [2])
C0016658 (UMLS CUI [3])
Mental disorders Limiting Safety | Mental disorders Limiting Protocol Compliance | Social situation Limiting Safety | Social situation Limiting Protocol Compliance
Item
10. concurrent psychiatric illness/social situations that would limit safety and compliance with study requirements
boolean
C0004936 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0036043 (UMLS CUI [1,3])
C0004936 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0748872 (UMLS CUI [3,1])
C0439801 (UMLS CUI [3,2])
C0036043 (UMLS CUI [3,3])
C0748872 (UMLS CUI [4,1])
C0439801 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Informed Consent Unable | Protocol Compliance Unable
Item
11. inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Investigational New Drugs
Item
12. currently receiving any other investigational therapeutic agents
boolean
C0013230 (UMLS CUI [1])
Deficiency of glucose-6-phosphate dehydrogenase | Porphyria | Liver Cirrhosis | Condition At risk
Item
13. patients with known glucose-6-phosphate dehydrogenase deficiency, porphyria, cirrhosis or any other conditions with potential significant known risks
boolean
C2939465 (UMLS CUI [1])
C3463940 (UMLS CUI [2])
C0023890 (UMLS CUI [3])
C0348080 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
Retinal damage
Item
14. patients with history of retinal damage
boolean
C0235272 (UMLS CUI [1])