Gender | Age
Item
1. women ≥ 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast Carcinoma | Secondary malignant neoplasm of female breast | Breast Carcinoma Estrogen receptor negative | Breast Carcinoma Progesterone receptor negative | Breast Carcinoma HER2 Negative | Immunohistochemistry | Overexpression Absent | FISH Negative | CISH Negative
Item
2. histologically documented breast cancer (either primary or metastatic site) that is (i) er-negative (0), (ii) pr-negative (0), and (iii) her2-negative, defined by ihc (immunohistochemistry; ihc 0/1, non-overexpressing) or fish (fluorescence in situ hybridization; fish negative) or cish (chromogen in situ hybridization; cish negative).
boolean
C0678222 (UMLS CUI [1])
C0346993 (UMLS CUI [2])
C0678222 (UMLS CUI [3,1])
C0279756 (UMLS CUI [3,2])
C0678222 (UMLS CUI [4,1])
C0279766 (UMLS CUI [4,2])
C0678222 (UMLS CUI [5,1])
C2348908 (UMLS CUI [5,2])
C0021044 (UMLS CUI [6])
C1514559 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0162789 (UMLS CUI [8,1])
C1513916 (UMLS CUI [8,2])
C1516514 (UMLS CUI [9,1])
C1513916 (UMLS CUI [9,2])
LHRH Receptor Expression | Breast Carcinoma Tissue specimen Immunohistochemistry | Breast Carcinoma Biopsy | Metastatic cancer site Biopsy
Item
3. expression of lhrh receptor confirmed by ihc on archival (or current biopsy of breast tumor or metastatic site) breast cancer tissue
boolean
C0034811 (UMLS CUI [1,1])
C0017262 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C1292533 (UMLS CUI [2,2])
C0021044 (UMLS CUI [2,3])
C0678222 (UMLS CUI [3,1])
C0005558 (UMLS CUI [3,2])
C0280457 (UMLS CUI [4,1])
C0005558 (UMLS CUI [4,2])
Progressive Disease | Prior Chemotherapy Quantity failed | Recurrent disease TNM Breast tumor staging | Neoplasm Metastasis TNM Breast tumor staging | Adjuvant therapy Previous | Neoadjuvant Therapy Previous
Item
4. progressive disease after failure of 1 to 3 prior chemotherapy regimens for recurrent or metastatic (stage iv) disease (prior adjuvant/neoadjuvant therapy is allowed)
boolean
C1335499 (UMLS CUI [1])
C1514457 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C0277556 (UMLS CUI [3,1])
C0474926 (UMLS CUI [3,2])
C0027627 (UMLS CUI [4,1])
C0474926 (UMLS CUI [4,2])
C0677850 (UMLS CUI [5,1])
C0205156 (UMLS CUI [5,2])
C0600558 (UMLS CUI [6,1])
C0205156 (UMLS CUI [6,2])
Measurable Disease | Prior radiation therapy Absent Target Lesion Quantity
Item
5. measurable disease by recist 1.1 criteria; at least one target lesion that has not been previously irradiated.
boolean
C1513041 (UMLS CUI [1])
C0279134 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C2986546 (UMLS CUI [2,3])
C1265611 (UMLS CUI [2,4])
ECOG performance status
Item
1. eastern cooperative oncology group (ecog) performance status > 2
boolean
C1520224 (UMLS CUI [1])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Myocardial Infarction
Item
2. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or recent myocardial infarction (within 6 months of enrollment)
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0027051 (UMLS CUI [6])
Leptomeningeal disease | Metastatic malignant neoplasm to brain | Requirement Steroids | Requirement Therapeutic Intervention
Item
3. leptomeningeal disease or brain metastases requiring steroids or other therapeutic intervention
boolean
C0751297 (UMLS CUI [1])
C0220650 (UMLS CUI [2])
C1514873 (UMLS CUI [3,1])
C0038317 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0808232 (UMLS CUI [4,2])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan
Item
4. left ventricular ejection fraction (lvef) < 50 %, determined by echocardiogram or muga scan
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
Organ function Impaired | Bone Marrow function Impaired
Item
5. compromised organ or marrow function as evidenced by any of the following:
boolean
C0678852 (UMLS CUI [1,1])
C0221099 (UMLS CUI [1,2])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0221099 (UMLS CUI [2,3])
Platelet Count measurement
Item
thrombocyte count: < 100x109/l
boolean
C0032181 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc): < 1.5x109/l
boolean
C0948762 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin: < 6.0 mmol/l (< 9 g/100 ml)
boolean
C0518015 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased | Relationship Secondary malignant neoplasm of liver
Item
as(a)t, al(a)t: > 2.5 times upper limit of normal range (uln) (> 5x uln if clearly related to liver metastases)
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
C0439849 (UMLS CUI [3,1])
C0494165 (UMLS CUI [3,2])
Serum total bilirubin measurement
Item
bilirubin: > 1.5 mg/dl
boolean
C1278039 (UMLS CUI [1])
Creatinine measurement, serum | Creatinine clearance measurement
Item
creatinine: > 1.5 mg/dl or creatinine clearance < 40 ml/min.
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
Cancer treatment Systemic | Therapeutic radiology procedure
Item
6. systemic anticancer therapy or radiotherapy within 21 calendar days of the first dose of study drug*)
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C1522449 (UMLS CUI [2])
Cancer treatment concomitant
Item
* also excluded are patients with anticipated ongoing concomitant anticancer therapy during the study
boolean
C0920425 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
Exposure to Anthracyclines | Exposure to Anthraquinones | Therapy Secondary malignant neoplasm of female breast | doxorubicin liposome | Doxil | Doxorubicin | Daunorubicin | Mitoxantrone
Item
7. prior exposure to anthracyclines or anthracenediones for the treatment of metastatic breast cancer including liposomal doxorubicin (doxil), doxorubicin, daunorubicin, or mitoxantrone
boolean
C0332157 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
C0332157 (UMLS CUI [2,1])
C0003174 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0346993 (UMLS CUI [3,2])
C0717726 (UMLS CUI [4])
C0279284 (UMLS CUI [5])
C0013089 (UMLS CUI [6])
C0011015 (UMLS CUI [7])
C0026259 (UMLS CUI [8])
Adjuvant therapy | Anthracyclines Cumulative Dose
Item
8. prior adjuvant anthracyclines with a cumulative anthracycline dose ≥ 300 mg/m2
boolean
C0677850 (UMLS CUI [1])
C0282564 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
Anticoagulation Therapy
Item
9. ongoing therapeutic anticoagulation
boolean
C0003281 (UMLS CUI [1])
Contraceptive methods mandatory | Exception Sexual sterilization | Exception Postmenopausal state
Item
10. patients who are not surgically sterile or post-menopausal must agree to use for the duration of the study reliable methods of birth control defined as:
boolean
C0700589 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0038288 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0232970 (UMLS CUI [3,2])
Sexual Abstinence Complete
Item
complete abstinence
boolean
C0036899 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
Intrauterine Devices
Item
any intrauterine device (iud) with published data showing that the lowest expected failure rate is < 1 % per year, or
boolean
C0021900 (UMLS CUI [1])
Contraceptive methods Effective
Item
any other methods with published data showing that the lowest expected failure rate is less than 1 % per year
boolean
C0700589 (UMLS CUI [1,1])
C1280519 (UMLS CUI [1,2])
Therapy, Investigational
Item
11. investigational therapy within 30 calendar days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication).
boolean
C0949266 (UMLS CUI [1])