Breast Carcinoma Primary tumor site | Secondary malignant neoplasm of female breast | Estrogen receptor negative Immunohistochemistry | Progesterone receptor negative Immunohistochemistry | HER2 Protein Overexpression Absent Immunohistochemistry | HER2 Protein Overexpression Absent FISH Negative
Item
histologically documented breast cancer (either primary or metastatic site) that is er (estrogen receptor)-negative, pgr (progesterone receptor)-negative ( <10% tumor staining by immunohistochemistry [ihc]) and her2 (human epidermal growth factor 2) non-overexpressing by ihc (0,1+) or, ihc 2+ and fish (fluorescence in situ hybridization) negative.
boolean
C0678222 (UMLS CUI [1,1])
C0475447 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2])
C0279756 (UMLS CUI [3,1])
C0021044 (UMLS CUI [3,2])
C0279766 (UMLS CUI [4,1])
C0021044 (UMLS CUI [4,2])
C1515560 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0021044 (UMLS CUI [5,3])
C1515560 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0162789 (UMLS CUI [6,3])
C1513916 (UMLS CUI [6,4])
Secondary malignant neoplasm of female breast | Measurable Disease
Item
metastatic breast cancer with measurable disease by the revised guideline for response evaluation criteria in solid tumors version 1.1 (recist 1.1 criteria);
boolean
C0346993 (UMLS CUI [1])
C1513041 (UMLS CUI [2])
Prior Therapy
Item
prior treatment that includes:
boolean
C1514463 (UMLS CUI [1])
Cancer treatment Absent Neoplasm Metastasis
Item
never having received anticancer therapy for metastatic disease or
boolean
C0920425 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
Prior Chemotherapy Quantity Neoplasm Metastasis | Neoadjuvant Therapy Systemic | Adjuvant therapy Systemic
Item
having received 1 or 2 prior chemotherapy regimens in the metastatic setting (prior neo-adjuvant/adjuvant systemic therapy is considered as a prior chemotherapy if the first relapse occurred less than one year after the last treatment administration).
boolean
C1514457 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0027627 (UMLS CUI [1,3])
C0600558 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C0677850 (UMLS CUI [3,1])
C0205373 (UMLS CUI [3,2])
gemcitabine | Carboplatin | Cisplatin | PARP Inhibitors
Item
prior treatment with gemcitabine, carboplatin, cisplatin or any parp inhibitor;
boolean
C0045093 (UMLS CUI [1])
C0079083 (UMLS CUI [2])
C0008838 (UMLS CUI [3])
C1882413 (UMLS CUI [4])
Secondary malignant neoplasm of bone | Disease Location only | Exception Soft tissue Component Measurable
Item
bone metastasis as only disease location (except for bone metastasis with measurable soft tissue component);
boolean
C0153690 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C1515974 (UMLS CUI [2,2])
C0205171 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0225317 (UMLS CUI [3,2])
C1705248 (UMLS CUI [3,3])
C1513040 (UMLS CUI [3,4])
Medical condition Major Affecting Study Subject Participation Status | Pulmonary Dysfunction Uncontrolled | Renal dysfunction Uncontrolled | Liver Dysfunction Uncontrolled | Communicable Disease Uncontrolled | Heart Disease Uncontrolled
Item
major medical conditions that might affect study participation e.g., uncontrolled pulmonary, renal, or hepatic dysfunction, uncontrolled infection, cardiac disease.
boolean
C3843040 (UMLS CUI [1,1])
C0205164 (UMLS CUI [1,2])
C0392760 (UMLS CUI [1,3])
C2348568 (UMLS CUI [1,4])
C1709770 (UMLS CUI [2,1])
C0205318 (UMLS CUI [2,2])
C3279454 (UMLS CUI [3,1])
C0205318 (UMLS CUI [3,2])
C0086565 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0009450 (UMLS CUI [5,1])
C0205318 (UMLS CUI [5,2])
C0018799 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
Study Subject Participation Status | Considerations Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C1524062 (UMLS CUI [2,2])