ID.1
Item
all patients:
boolean
HER2-positive carcinoma of breast; Estrogen receptor positive; Recurrent disease; Progressive Disease; Metastatic Neoplasm
Item
diagnosed with progressive, recurrent or metastatic her2+ or er+ breast cancer.
boolean
C1960398 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C0277556 (UMLS CUI [1,3])
C1335499 (UMLS CUI [1,4])
C2939420 (UMLS CUI [1,5])
ID.3
Item
cohort 1
boolean
Prior Chemotherapy; Adjuvant therapy; trastuzumab; pertuzumab; lapatinib; ado-trastuzumab emtansine | Progressive Disease; Recurrent disease; Metastatic Neoplasm; Breast Carcinoma
Item
patients who previously received treatment with anti-her2 therapy (including trastuzumab, pertuzumab, tdm1, or lapatinib) as part of adjuvant chemotherapy and now have progressive or recurrent breast cancer or, patients who previously (or currently) received anti-her2 therapy as part of a regimen for metastatic breast cancer and subsequently experienced.
boolean
C1514457 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0728747 (UMLS CUI [1,3])
C1328025 (UMLS CUI [1,4])
C1506770 (UMLS CUI [1,5])
C2935436 (UMLS CUI [1,6])
C1335499 (UMLS CUI [2,1])
C0277556 (UMLS CUI [2,2])
C2939420 (UMLS CUI [2,3])
C0678222 (UMLS CUI [2,4])
disease progression or recurrence after prior therapy
Item
evidence of disease progression or recurrence after prior therapy (e.g. radiologic progression by recist criteria or new metastasis).
boolean
C0242656 (UMLS CUI [1])
C0679254 (UMLS CUI [2])
C1514463 (UMLS CUI [3])
biopsy of breast showed her2 positive carcinoma
Item
prior tumor biopsy (may be original) defined as her2+ by amplification by fish (>1.9 gene copy number) or ihc 3+.
boolean
C4031572 (UMLS CUI [1])
ID.7
Item
cohort 2
boolean
Prior Hormone Therapy; Adjuvant therapy | Tamoxifen; Toremifene; Raloxifene; anastrozole; letrozole; exemestane; fulvestrant; Selective Estrogen Receptor Degrader ARN-810 | Progressive Disease; Recurrent disease; Metastatic Neoplasm; Breast Carcinoma
Item
patients who previously received treatment with hormonal therapy (including tamoxifen, toremifene, raloxifene, anastrozole, letrozole, exemestane, fulvestrant, arn-810) as a part of adjuvant therapy and now have progressive or recurrent breast cancer or patients who previously (or currently) receive hormonal therapy as part of a regimen for metastatic breast cancer and subsequently experienced evidence of disease progression.
boolean
C1514460 (UMLS CUI [1,1])
C0677850 (UMLS CUI [1,2])
C0039286 (UMLS CUI [2,1])
C0076836 (UMLS CUI [2,2])
C0244404 (UMLS CUI [2,3])
C0290883 (UMLS CUI [2,4])
C0246421 (UMLS CUI [2,5])
C0851344 (UMLS CUI [2,6])
C0935916 (UMLS CUI [2,7])
C3827161 (UMLS CUI [2,8])
C1335499 (UMLS CUI [3,1])
C0277556 (UMLS CUI [3,2])
C2939420 (UMLS CUI [3,3])
C0678222 (UMLS CUI [3,4])
ID.9
Item
cohort 3
boolean
received therapy for breast cancer
Item
patients not eligible for cohorts 1 or 2, but previously received treatment of any other kind for breast cancer.
boolean
C0332154 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
informed consent, biopsy
Item
patients who are unable to consent to a biopsy.
boolean
C0021430 (UMLS CUI [1,1])
C0677862 (UMLS CUI [1,2])
Repeat; Biopsy; Medical contraindication
Item
patients for whom a repeat biopsy would be medically unsafe
boolean
C0205341 (UMLS CUI [1,1])
C0005558 (UMLS CUI [1,2])
C1301624 (UMLS CUI [1,3])