Postmenopausal state
Item
postmenopausal female patients
boolean
C0232970 (UMLS CUI [1])
Oestrogen receptor positive breast cancer
Item
histologically or cytologically confirmed er+ breast cancer
boolean
C2938924 (UMLS CUI [1])
Aromatase Inhibitors | Recurrent disease | Disease Progression
Item
relapsed or progressed on prior treatment with ai
boolean
C0593802 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0242656 (UMLS CUI [3])
Neoplasm Metastasis Measurable
Item
metastatic disease must be measurable
boolean
C0027627 (UMLS CUI [1,1])
C1513040 (UMLS CUI [1,2])
Palliative Radiation Therapy Lesion Non-Target | Washout Period Patient need for
Item
patients receiving palliative radiation at the non-target lesions must have a 2 week wash out period following completion of the treatment prior to enrollment
boolean
C3898008 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C1518389 (UMLS CUI [1,3])
C1710661 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
First line treatment Prior Chemotherapy Quantity | Status pre- Aromatase Inhibitors
Item
patient may have had one prior chemotherapy as part of first line therapy as long as it was received before initiation of prior ai
boolean
C1708063 (UMLS CUI [1,1])
C1514457 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0332152 (UMLS CUI [2,1])
C0593802 (UMLS CUI [2,2])
ECOG performance status
Item
ecog performance status: 0 to 1
boolean
C1520224 (UMLS CUI [1])
Laboratory Results | Hemoglobin measurement | Platelet Count measurement | Absolute neutrophil count | Hematopoietic Growth Factors Absent | Creatinine measurement, serum | Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
laboratory parameters: a)hemoglobin ≥ 9.0 g/dl; platelets ≥ 100.0 x 109/l; anc ≥ 1.5 x 109/l without the use of hematopoietic growth factors b)creatinine less than 2.5 times the upper limit of normal for the institution c)ast and alt less than 2.5 times the upper limit of normal for the institution
boolean
C1254595 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0079490 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0201976 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
Informed Consent | Protocol Compliance
Item
able to understand and give written informed consent and comply with study procedures
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Non-Steroidal Aromatase Inhibitor | Recurrent disease | Adjuvant therapy
Item
relapse on treatment with non-steroidal ai after less than 12 months for patients in the adjuvant setting
boolean
C1518386 (UMLS CUI [1])
C0277556 (UMLS CUI [2])
C0677850 (UMLS CUI [3])
Aromatase Inhibitors Neoplasm Metastasis | Progressive Disease
Item
progressive disease after less than 3 months treatment with most recent ai for patients with metastatic disease
boolean
C0593802 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C1335499 (UMLS CUI [2])
Neoplasm Metastasis Life Threatening Rapidly progressive
Item
rapidly progressive, life-threatening metastases
boolean
C0027627 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C1838681 (UMLS CUI [1,3])
Palliative course of radiotherapy Measurable lesion
Item
any palliative radiotherapy to the measurable lesion
boolean
C0475092 (UMLS CUI [1,1])
C1513041 (UMLS CUI [1,2])
SNDX-275 | Histone deacetylase inhibitor | Valproic Acid
Item
previous treatment with sndx-275 or any other hdac inhibitor including valproic acid
boolean
C4048552 (UMLS CUI [1])
C1512474 (UMLS CUI [2])
C0042291 (UMLS CUI [3])
Hypersensitivity Benzamides | Hypersensitivity Investigational New Drugs inactive ingredient
Item
allergy to benzamides or inactive components of the study drug
boolean
C0020517 (UMLS CUI [1,1])
C0005029 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C1552019 (UMLS CUI [2,3])
Hypersensitivity Exemestane Active ingredient | Hypersensitivity Exemestane Inactive ingredient
Item
a history of allergies to any active or inactive ingredients of exemestane
boolean
C0020517 (UMLS CUI [1,1])
C0851344 (UMLS CUI [1,2])
C1372955 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0851344 (UMLS CUI [2,2])
C1552019 (UMLS CUI [2,3])
Comorbidity Excludes Protocol Compliance
Item
any concomitant medical condition that precludes adequate study treatment compliance
boolean
C0009488 (UMLS CUI [1,1])
C0332196 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drugs
Item
patient is currently enrolled in (or completed within 30 days before study drug administration) another investigational drug study
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
Valproic Acid | Zolinza | Vorinostat | Histone deacetylase inhibitor | DNA Methyltransferase Inhibitors | Cancer treatment Systemic | Exception Lupron
Item
patient is currently receiving treatment with valproic acid, zolinza(vorinostat) or any other hdac inhibitor or dna methyltransferase inhibitor or any systemic anticancer treatment (with the exception of lupron)
boolean
C0042291 (UMLS CUI [1])
C1738860 (UMLS CUI [2])
C0672708 (UMLS CUI [3])
C1512474 (UMLS CUI [4])
C1511682 (UMLS CUI [5])
C0920425 (UMLS CUI [6,1])
C0205373 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0701459 (UMLS CUI [7,2])