Postmenopausal state | Oestrogen receptor positive breast cancer
Item
postmenopausal, estrogen-receptor positive breast cancer
boolean
C0232970 (UMLS CUI [1])
C2938924 (UMLS CUI [2])
Dose Escalation | Hormone Therapy Quantity | Cytotoxic Chemotherapy Neoplasm Metastasis Advanced | Cytotoxic Chemotherapy Locally Advanced Disease Setting
Item
phase ib dose escalation only: any number of prior lines of endocrine therapy is allowed with the exception of cytotoxic therapy which is limited to one prior line administered in the advanced (metastatic or locally advanced) setting.
boolean
C3816728 (UMLS CUI [1])
C0279025 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0677881 (UMLS CUI [3,1])
C0027627 (UMLS CUI [3,2])
C0205179 (UMLS CUI [3,3])
C0677881 (UMLS CUI [4,1])
C4086552 (UMLS CUI [4,2])
Dose Expansion | Systemic therapy Absent | Neoplasm Metastasis Advanced | Locally Advanced Disease Setting | Exception Letrozole
Item
phase ib dose expansions: no prior systemic treatment in the advanced (metastatic or locally advanced) setting with the exception of treatment with letrozole for a maximum of one month prior to starting study treatment.
boolean
C4521283 (UMLS CUI [1])
C1515119 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3,1])
C0205179 (UMLS CUI [3,2])
C4086552 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C0246421 (UMLS CUI [5,2])
Systemic therapy Absent | Neoplasm Metastasis Advanced | Locally Advanced Disease Setting
Item
phase ii: no prior systemic treatment in the advanced (metastatic or locally advanced) setting.
boolean
C1515119 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027627 (UMLS CUI [2,1])
C0205179 (UMLS CUI [2,2])
C4086552 (UMLS CUI [3])
Dose Expansion | Neoadjuvant Therapy Breast Carcinoma | Adjuvant therapy Breast Carcinoma | letrozole | anastrozole | Interval Disease Free
Item
phase ib dose expansions and phase ii: patients who received (neo)adjuvant therapy for breast cancer are eligible. prior therapy with letrozole or anastrozole in the (neo)adjuvant setting is permitted if the disease free interval is greater than 12 months from the completion of treatment.
boolean
C4521283 (UMLS CUI [1])
C0600558 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C0677850 (UMLS CUI [3,1])
C0678222 (UMLS CUI [3,2])
C0246421 (UMLS CUI [4])
C0290883 (UMLS CUI [5])
C1272706 (UMLS CUI [6,1])
C0012634 (UMLS CUI [6,2])
C0332296 (UMLS CUI [6,3])
Tumor tissue sample HER2 Protein Overexpression
Item
her2-overexpression in the patient's tumor tissue
boolean
C0475358 (UMLS CUI [1,1])
C1515560 (UMLS CUI [1,2])
CNS metastases | Metastatic malignant neoplasm to brain
Item
patients with active cns or other brain metastases
boolean
C0686377 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
Major surgery
Item
major surgery within 2 weeks
boolean
C0679637 (UMLS CUI [1])
Pancreatitis | Pancreatitis, Chronic
Item
acute or chronic pancreatitis
boolean
C0030305 (UMLS CUI [1])
C0149521 (UMLS CUI [2])
Lymphangitis carcinomatosa Diffuse Bilateral
Item
bilateral diffuse lymphangitic carcinomatosis
boolean
C0238258 (UMLS CUI [1,1])
C0205219 (UMLS CUI [1,2])
C0238767 (UMLS CUI [1,3])
Cancer Other
Item
another malignancy within 3 years
boolean
C1707251 (UMLS CUI [1])
Hormone replacement therapy Discontinuation Unsuccessful
Item
receiving hormone replacement therapy that cannot be discontinued
boolean
C0282402 (UMLS CUI [1,1])
C1444662 (UMLS CUI [1,2])
C1272705 (UMLS CUI [1,3])
Decreased cardiac function
Item
impaired cardiac function
boolean
C0232166 (UMLS CUI [1])
Diabetes Mellitus Treated | Sign or Symptom Diabetes Mellitus | Glucose measurement, fasting | Hemoglobin A1c measurement | Gestational Diabetes | Steroid-induced diabetes
Item
patients with clinically manifest diabetes mellitus (treated and/or clinical signs or with fasting glucose ≥ 126 mg/dl / 7.0 mmol/l or hemoglobin a1c >6.5%), history of gestational diabetes mellitus or documented steroid-induced diabetes mellitus.
boolean
C0011849 (UMLS CUI [1,1])
C1522326 (UMLS CUI [1,2])
C3540840 (UMLS CUI [2,1])
C0011849 (UMLS CUI [2,2])
C0202045 (UMLS CUI [3])
C0474680 (UMLS CUI [4])
C0085207 (UMLS CUI [5])
C0342269 (UMLS CUI [6])
Clinical Trial Eligibility Criteria Study Protocol
Item
other protocol-defined inclusion/exclusion criteria may apply
boolean
C1516637 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])