Eligibility Metastatic Breast Cancer NCT02263495

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StudyEvent: Eligibility
1. Eligibility Metastatic Breast Cancer NCT02263495

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

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])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

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])

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Eligibility Metastatic Breast Cancer NCT02263495