Breast Carcinoma | Neoadjuvant Chemotherapy | Chemotherapy, Adjuvant | Doxorubicin | Cyclophosphamide | Adenocarcinoma of the prostate metastatic | docetaxel
Item
histologically confirmed breast cancer for which chemotherapy with ac (doxorubicin plus cyclophosphamide) is being utilized in the neoadjuvant or adjuvant setting or metastatic prostate adenocarcinoma for which docetaxel will be administered
boolean
C0678222 (UMLS CUI [1])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0085533 (UMLS CUI [3])
C0013089 (UMLS CUI [4])
C0010583 (UMLS CUI [5])
C0862636 (UMLS CUI [6])
C0246415 (UMLS CUI [7])
Body mass index
Item
body mass index (bmi) >= 18.5
boolean
C1305855 (UMLS CUI [1])
Requirement Absent Measurable Disease | Requirement Absent Evaluable Disease | Neoadjuvant Chemotherapy | Chemotherapy, Adjuvant | Chemotherapy Neoplasm Metastasis
Item
subjects do not need to have measurable or evaluable disease; chemotherapy may be administered in the neoadjuvant, adjuvant, or metastatic setting
boolean
C1514873 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C1513041 (UMLS CUI [1,3])
C1514873 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1516986 (UMLS CUI [2,3])
C0600558 (UMLS CUI [3,1])
C3665472 (UMLS CUI [3,2])
C0085533 (UMLS CUI [4])
C0392920 (UMLS CUI [5,1])
C0027627 (UMLS CUI [5,2])
Prior Therapy
Item
prior therapy:
boolean
C1514463 (UMLS CUI [1])
Breast Carcinoma Study Subject | Prior Chemotherapy Absent | Exception Chemotherapy Curative Cancer Other
Item
breast cancer subjects may not have received prior chemotherapy, with the exception of curative-intent chemotherapy for a separate malignancy more than 3 years ago
boolean
C0678222 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1514457 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C1276305 (UMLS CUI [3,3])
C1707251 (UMLS CUI [3,4])
Prostate carcinoma Study Subject | Prior Therapy | Metronomic Cyclophosphamide | Antiangiogenic therapy | Immunomodulation | Cytotoxic Chemotherapy Absent
Item
prostate cancer subjects may have received prior treatment with metronomic cyclophosphamide as this is considered anti-angiogenic/immunomodulatory and not cytotoxic
boolean
C0600139 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2])
C1881814 (UMLS CUI [3,1])
C0010583 (UMLS CUI [3,2])
C2363719 (UMLS CUI [4])
C1963758 (UMLS CUI [5])
C0677881 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
Prostate carcinoma Study Subject | Course second Docetaxel | Course First PSA Response | PSA decreased | Improvement Radiography | Improvement Pain
Item
prostate cancer subjects may be receiving a 2nd course of docetaxel provided that ** the first course resulted in a psa response (> 30% reduction in prostate specific antigen [psa] and/or improvement in radiographic findings or pain) and the last dose was >= 9 months ago
boolean
C0600139 (UMLS CUI [1,1])
C0681850 (UMLS CUI [1,2])
C0750729 (UMLS CUI [2,1])
C0205436 (UMLS CUI [2,2])
C0246415 (UMLS CUI [2,3])
C0750729 (UMLS CUI [3,1])
C0205435 (UMLS CUI [3,2])
C0138741 (UMLS CUI [3,3])
C1704632 (UMLS CUI [3,4])
C0178414 (UMLS CUI [4])
C2986411 (UMLS CUI [5,1])
C0034571 (UMLS CUI [5,2])
C2986411 (UMLS CUI [6,1])
C0030193 (UMLS CUI [6,2])
Prior radiation therapy
Item
prior radiotherapy is allowed, provided at least 2 weeks have elapsed from completion of radiotherapy to initiation of protocol treatment
boolean
C0279134 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-1
boolean
C1520224 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
aspartate aminotransferase (ast) and alanine aminotransferase (alt) < 2x upper limit of normal (uln)
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Absolute neutrophil count
Item
absolute neutrophil count (anc) > 1500
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets (plts) > 90,000
boolean
C0032181 (UMLS CUI [1])
Premenopausal state Pregnancy test negative | Premenopausal state Barrier Contraception
Item
premenopausal women must have a negative pregnancy test and must agree to use barrier contraception throughout the study period
boolean
C0232969 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C0232969 (UMLS CUI [2,1])
C0004764 (UMLS CUI [2,2])
Diabetes Mellitus
Item
diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Peripheral Neuropathy CTCAE Grades
Item
peripheral neuropathy >= grade 1
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Prior Therapy | IGF-1 inhibitors
Item
prior therapy with inhibitors of igf-1
boolean
C1514463 (UMLS CUI [1])
C0021665 (UMLS CUI [2,1])
C0243077 (UMLS CUI [2,2])
Somatostatin
Item
concurrent use of somatostatin
boolean
C0037659 (UMLS CUI [1])
Food Allergy | Shellfish allergy | Allergy to soy | Allergy to eggs
Item
significant food allergies which would make the subject unable to consume the food provided (ex: shellfish, soy or egg allergy)
boolean
C0016470 (UMLS CUI [1])
C0577625 (UMLS CUI [2])
C4075590 (UMLS CUI [3])
C0559469 (UMLS CUI [4])