Postmenopausal state | Bilateral oophorectomy | Amenorrhea Duration
Item
post-menopausal women (either through bilateral oophorectomy or amenorrhoeic for 24 months)
boolean
C0232970 (UMLS CUI [1])
C0278321 (UMLS CUI [2])
C0002453 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
Oestrogen receptor positive breast cancer
Item
histological confirmation of breast cancer with documented er+ receptor status
boolean
C2938924 (UMLS CUI [1])
Relapse | Hormone Therapy Adjuvant Completed | Anti-Inflammatory Agents, Non-Steroidal | Tamoxifen | Disease Progression | Status post First line Hormone Therapy
Item
safety run-in: relapsing during/within 12 months of completion of a single regimen of adjuvant endocrine therapy with non-steroidal ai and/ tamoxifen or progression following 1st line endocrine therapy with non-steroidal al
boolean
C0035020 (UMLS CUI [1])
C0279025 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
C0003211 (UMLS CUI [3])
C0039286 (UMLS CUI [4])
C0242656 (UMLS CUI [5])
C0231290 (UMLS CUI [6,1])
C1708063 (UMLS CUI [6,2])
C0279025 (UMLS CUI [6,3])
Hormone Therapy Quantity Metastatic Setting | Relapse | Hormone Therapy Adjuvant Completed | Anti-Inflammatory Agents, Non-Steroidal | Tamoxifen | Combined Modality Therapy | Chemotherapy Adjuvant Setting allowed
Item
rand phase iia: received at least 1 prior endocrine therapy in the metastatic setting or have relapsed during/ within 6 months of completion of adjuvant endocrine therapy (either non-steroidal ai or tamoxifen or a combination of both). chemotherapy administered in the adjuvant setting is permitted.
boolean
C0279025 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C4085632 (UMLS CUI [1,3])
C0035020 (UMLS CUI [2])
C0279025 (UMLS CUI [3,1])
C1522673 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
C0003211 (UMLS CUI [4])
C0039286 (UMLS CUI [5])
C0009429 (UMLS CUI [6])
C0392920 (UMLS CUI [7,1])
C4084850 (UMLS CUI [7,2])
C0683607 (UMLS CUI [7,3])
Tumor tissue sample mandatory | FGFR1 Polysomy | FGFR1 Gene Amplification | Measurable lesion Quantity CT | Measurable lesion Quantity MRI | Measurable lesion Quantity X-Ray
Item
rand phase iia: mandatory provision of tumour sample to confirm fgfr1 polysomy or gene amplification. at least one measurable lesion that can be accurately assessed by ct/mri/x-ray at baseline and follow up visits
boolean
C0475358 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0919509 (UMLS CUI [2,1])
C1514212 (UMLS CUI [2,2])
C0919509 (UMLS CUI [3,1])
C0017256 (UMLS CUI [3,2])
C1513041 (UMLS CUI [4,1])
C1265611 (UMLS CUI [4,2])
C0040405 (UMLS CUI [4,3])
C1513041 (UMLS CUI [5,1])
C1265611 (UMLS CUI [5,2])
C0024485 (UMLS CUI [5,3])
C1513041 (UMLS CUI [6,1])
C1265611 (UMLS CUI [6,2])
C0043299 (UMLS CUI [6,3])
Exposure to Exemestane | Exposure to Fulvestrant | Exposure to FGFR Inhibitor
Item
prior exposure to exemestane (safety run-in) / fulvestrant (randomized phase iia), or any agent known to inhibit fgfrs.
boolean
C0332157 (UMLS CUI [1,1])
C0851344 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0935916 (UMLS CUI [2,2])
C0332157 (UMLS CUI [3,1])
C0060369 (UMLS CUI [3,2])
C1999216 (UMLS CUI [3,3])
Prior Chemotherapy Quantity Breast Carcinoma
Item
more than 1 prior regimen of chemotherapy for breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0678222 (UMLS CUI [1,3])
Abnormal heart rate Electrocardiography | Cardiac Arrhythmia Electrocardiography | Abnormal cardiac conduction Electrocardiography
Item
ecg recordings that demonstrate significant abnormalities in cardiac rate, rhythm or conduction
boolean
C1744601 (UMLS CUI [1,1])
C1623258 (UMLS CUI [1,2])
C0003811 (UMLS CUI [2,1])
C1623258 (UMLS CUI [2,2])
C0232219 (UMLS CUI [3,1])
C1623258 (UMLS CUI [3,2])
Hypersensitivity Excipient AZD4547 | Hypersensitivity Excipient Exemestane | Hypersensitivity Excipient Fulvestrant | Hypersensitivity Excipient Castor Oil | Hypersensitivity Drug Similar
Item
history of hypersensitivity to active or inactive excipients of azd4547 or exemestane (safety run-in ) or fulvestrant (randomized phase), including castor oil, or drugs with a similar chemical structure or class to azd4547 or exemestane or fulvestrant.
boolean
C0020517 (UMLS CUI [1,1])
C0015237 (UMLS CUI [1,2])
C2981795 (UMLS CUI [1,3])
C0020517 (UMLS CUI [2,1])
C0015237 (UMLS CUI [2,2])
C0851344 (UMLS CUI [2,3])
C0020517 (UMLS CUI [3,1])
C0015237 (UMLS CUI [3,2])
C0935916 (UMLS CUI [3,3])
C0020517 (UMLS CUI [4,1])
C0015237 (UMLS CUI [4,2])
C0007343 (UMLS CUI [4,3])
C0020517 (UMLS CUI [5,1])
C1254351 (UMLS CUI [5,2])
C2348205 (UMLS CUI [5,3])
Hemorrhage | Blood Clotting | Fulvestrant Injection Buttocks Preventing
Item
randomized phase iia: bleeding/blood clotting conditions that would prevent the administration of the fulvestrant injection into the buttocks
boolean
C0019080 (UMLS CUI [1])
C0302148 (UMLS CUI [2])
C0935916 (UMLS CUI [3,1])
C1828121 (UMLS CUI [3,2])
C0006497 (UMLS CUI [3,3])
C1292733 (UMLS CUI [3,4])