Secondary malignant neoplasm of female breast | Breast cancer recurrent
Item
1. histologically confirmed metastatic, or recurrent breast cancer
boolean
C0346993 (UMLS CUI [1])
C0278493 (UMLS CUI [2])
Breast Carcinoma HER2 Negative
Item
2. her2-negative breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C2348908 (UMLS CUI [1,2])
Age
Item
3. age > 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
4. ecog performance status 0 - 2
boolean
C1520224 (UMLS CUI [1])
Premenopausal breast cancer | Breast Carcinoma Postmenopausal | Measurable Disease | Non-Measurable Lesion | Patients Appropriate Chemotherapy
Item
5. pre- or postmenopausal breast cancer patients with measurable or non-measurable lesions, who are candidates for chemotherapy
boolean
C0741682 (UMLS CUI [1])
C0678222 (UMLS CUI [2,1])
C0232970 (UMLS CUI [2,2])
C1513041 (UMLS CUI [3])
C1334988 (UMLS CUI [4])
C0030705 (UMLS CUI [5,1])
C1548787 (UMLS CUI [5,2])
C0392920 (UMLS CUI [5,3])
Life Expectancy
Item
6. life expectancy ≥ 3 months
boolean
C0023671 (UMLS CUI [1])
Prior Chemotherapy Absent Secondary malignant neoplasm of female breast | Prior Chemotherapy Absent Breast cancer recurrent
Item
7. no prior history of chemotherapy for metastatic, recurrent breast cancer
boolean
C1514457 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0346993 (UMLS CUI [1,3])
C1514457 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0278493 (UMLS CUI [2,3])
Taxane Neoadjuvant Therapy Completed | Taxane Adjuvant therapy Completed
Item
8. patients may have received prior neoadjuvant or adjuvant taxane regimen as long as it has been 12 months since completion of regimen.
boolean
C0215136 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0205197 (UMLS CUI [1,3])
C0215136 (UMLS CUI [2,1])
C0677850 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Prior Therapy Anthracyclines | Absence Prior Therapy Anthracyclines
Item
9. patients either may or may not have a prior anthracycline containing regimen.
boolean
C1514463 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
C0332197 (UMLS CUI [2,1])
C1514463 (UMLS CUI [2,2])
C0282564 (UMLS CUI [2,3])
Prior Hormone Therapy Neoplasm Metastasis | Hormone Therapy Completed Against Tumor
Item
10. prior hormonal therapy as a treatment of metastatic disease is allowed. but antitumoral hormonal therapy must be terminated prior to enrollment(up to the date of randomization)
boolean
C1514460 (UMLS CUI [1,1])
C0027627 (UMLS CUI [1,2])
C0279025 (UMLS CUI [2,1])
C0205197 (UMLS CUI [2,2])
C0521124 (UMLS CUI [2,3])
C0027651 (UMLS CUI [2,4])
Prior radiation therapy Bone Marrow Percentage | Toxic effects Due to Therapeutic procedure | Patient recovered | Absence Prior radiation therapy Whole Pelvis | Prior radiation therapy Completed
Item
11. prior radiation therapy allowed as long as < 25% of the bone marrow has been treated, and the patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. prior radiation to the whole pelvis is not allowed. prior radiotherapy must be completed 2 weeks before study entry.
boolean
C0279134 (UMLS CUI [1,1])
C0005953 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C0600688 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0087111 (UMLS CUI [2,3])
C1115804 (UMLS CUI [3])
C0332197 (UMLS CUI [4,1])
C0279134 (UMLS CUI [4,2])
C3827467 (UMLS CUI [4,3])
C0279134 (UMLS CUI [5,1])
C0205197 (UMLS CUI [5,2])
Diphosphonates | Therapy Secondary malignant neoplasm of bone
Item
12. bisphosphonates for the treatment of bone metastases should not be initiated following the first dose of randomized therapy. it must be initiated prior to day of treatment (cycle 1, day 1). patients may continue on bisphosphonates who already established on bisphosphonate therapy for bone metastases
boolean
C0012544 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0153690 (UMLS CUI [2,2])
Bone Marrow function | Absolute neutrophil count | Platelet Count measurement | Hemoglobin measurement
Item
13. adequate bone marrow function (≥ anc 1,500/ul, ≥ platelet 100,000/ul, ≥ hemoglobin 9.0 g/dl)
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0948762 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
C0518015 (UMLS CUI [4])
Renal function | Creatinine measurement, serum | Creatinine clearance measurement
Item
14. adequate renal function (≤ serum creatinine 1.5 mg/dl or ccr ≥ 50 ml/min)
boolean
C0232804 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0373595 (UMLS CUI [3])
Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Relationship Secondary malignant neoplasm of liver
Item
15. adequate liver function (≤ serum bilirubin 1.5 mg/dl, ≤ ast & altx3 upper normal limit or ast and alt ≤ 5.0xuln if judged by the investigator to be related to liver metastases)
boolean
C0232741 (UMLS CUI [1])
C1278039 (UMLS CUI [2])
C0201899 (UMLS CUI [3])
C0201836 (UMLS CUI [4])
C0439849 (UMLS CUI [5,1])
C0494165 (UMLS CUI [5,2])
Informed Consent
Item
16. written informed consent
boolean
C0021430 (UMLS CUI [1])
Communicable Diseases Serious Uncontrolled
Item
1. serious uncontrolled intercurrent infections
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0205318 (UMLS CUI [1,3])
Comorbidity Serious | Mental disorders Serious | Heart Disease
Item
2. serious intercurrent medical or psychiatric illness, including active cardiac disease
boolean
C0009488 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0004936 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
C0018799 (UMLS CUI [3])
Pregnancy | Breast Feeding
Item
3. pregnancy or breast feeding
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Second Primary Cancer | Exception Carcinoma in situ of uterine cervix | Exception Skin carcinoma Treated | Exception Cancer Other Treated | Exception Recurrence Absent
Item
4. second primary malignancy(except in situ carcinoma of the cervix or adequately treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5 years previously with no evidence of recurrence)
boolean
C0751623 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0851140 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0699893 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1707251 (UMLS CUI [4,2])
C1522326 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0034897 (UMLS CUI [5,2])
C0332197 (UMLS CUI [5,3])
Metastatic malignant neoplasm to brain Parenchymal | Metastatic malignant neoplasm to brain Leptomeningeal
Item
5. documented parenchymal or leptomeningeal brain metastasis
boolean
C0220650 (UMLS CUI [1,1])
C4277702 (UMLS CUI [1,2])
C0220650 (UMLS CUI [2,1])
C0521401 (UMLS CUI [2,2])
Peripheral Neuropathy CTCAE Grades
Item
6. peripheral neuropathy ≥ grade 2
boolean
C0031117 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
gemcitabine
Item
7. prior treatment with gemcitabine will not be allowed.
boolean
C0045093 (UMLS CUI [1])
Breast Carcinoma HER2 Protein Overexpression Plus Trastuzumab
Item
8. her-2 overexpressing breast cancer and concomitant trastuzumab treatment is not allowed
boolean
C0678222 (UMLS CUI [1,1])
C1515560 (UMLS CUI [1,2])
C0332287 (UMLS CUI [1,3])
C0728747 (UMLS CUI [1,4])
Childbearing Potential Contraceptive methods Unwilling
Item
9. women of childbearing potential, unwilling to use a medically acceptable method of contraception during the trial
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])