ID

27246

Beschrijving

Adjuvant AI Combined With Zoladex; ODM derived from: https://clinicaltrials.gov/show/NCT01352091

Link

https://clinicaltrials.gov/show/NCT01352091

Trefwoorden

Versies (1)
  1. 05-11-17 05-11-17 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

5 november 2017

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01352091

Engels

Eligibility Breast Cancer NCT01352091

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. all patients must have signed and dated an informed consent form
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
2. patients must be female
Beschrijving

Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0079399
3. primary invasive breast cancer pathologically approved by core needle or open biopsy
Beschrijving

Invasive carcinoma of breast Primary Core needle biopsy | Invasive carcinoma of breast Primary Incisional biopsy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205225
UMLS CUI [1,3]
C1318309
UMLS CUI [2,1]
C0853879
UMLS CUI [2,2]
C0205225
UMLS CUI [2,3]
C0184922
4. ipsilateral axillary or internal mammary nodes positive, or tumor size is equal to or larger than 4cm. definition of nodes positive is according to the staging system of ajcc 6th edition (american joint cancer commission) for breast carcinoma. the micrometastasis must be at least 0.2mm
Beschrijving

Positive Axillary Lymph Node Ipsilateral TNM Breast tumor staging | Internal mammary node Positive TNM Breast tumor staging | Tumor size | Neoplasm Micrometastasis

Datatype

boolean

Alias
UMLS CUI [1,1]
C0677929
UMLS CUI [1,2]
C0441989
UMLS CUI [1,3]
C0474926
UMLS CUI [2,1]
C0447180
UMLS CUI [2,2]
C1514241
UMLS CUI [2,3]
C0474926
UMLS CUI [3]
C0475440
UMLS CUI [4]
C1513276
5. patients must have undergone standard surgery for primary breast cancer as shown in the following:
Beschrijving

Operative Surgical Procedures Breast Carcinoma Primary

Datatype

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0678222
UMLS CUI [1,3]
C0205225
a standard radical mastectomy or modified mastectomy
Beschrijving

Mastectomy, Radical | Modified mastectomy

Datatype

boolean

Alias
UMLS CUI [1]
C0024884
UMLS CUI [2]
C0024883
standard breast conservation surgery (bcs), which is lumpectomy or qaudrantectomy accompany with axillary dissection, and the surgical margins of the resected specimen must be negative. bcs must be followed by standardized adjuvant radiotherapy to the partial conserved breast (delivered after adjuvant chemotherapy completed)
Beschrijving

Breast-Conserving Surgery | Segmental Mastectomy | Quadrantectomy of breast | Excision of axillary lymph nodes | Negative Surgical Margin | Radiotherapy, Adjuvant | Adjuvant Chemotherapy Completed

Datatype

boolean

Alias
UMLS CUI [1]
C0917927
UMLS CUI [2]
C0024885
UMLS CUI [3]
C0337354
UMLS CUI [4]
C0193867
UMLS CUI [5]
C1709157
UMLS CUI [6]
C0242939
UMLS CUI [7,1]
C0085533
UMLS CUI [7,2]
C0205197
treatment for confirmed breast cancer including the surgery modality listed above, loco-regional radiotherapy after lumpectomy, adjuvant radiotherapy to the chest wall and/or internal mammary nodes and/or supraclavicular lymph nodes, adjuvant chemotherapy
Beschrijving

Therapeutic procedure Breast Carcinoma | Operative Surgical Procedures | Therapeutic radiology procedure Local-Regional | Segmental Mastectomy | Adjuvant Radiotherapy Chest wall | Adjuvant Radiotherapy Internal mammary node | Adjuvant Radiotherapy supraclavicular lymph node | Chemotherapy, Adjuvant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0678222
UMLS CUI [2]
C0543467
UMLS CUI [3,1]
C1522449
UMLS CUI [3,2]
C1947913
UMLS CUI [4]
C0024885
UMLS CUI [5,1]
C0242939
UMLS CUI [5,2]
C0205076
UMLS CUI [6,1]
C0242939
UMLS CUI [6,2]
C0447180
UMLS CUI [7,1]
C0242939
UMLS CUI [7,2]
C0229730
UMLS CUI [8]
C0085533
6. adjuvant endocrine therapy of tam or fareston must be started within 6 weeks when adjuvant chemotherapy or radiotherapy was finished
Beschrijving

Hormone Therapy Adjuvant | Tamoxifen | Fareston

Datatype

boolean

Alias
UMLS CUI [1,1]
C0279025
UMLS CUI [1,2]
C1522673
UMLS CUI [2]
C0039286
UMLS CUI [3]
C0600382
7. the date of randomization must be processed after taking tam or fareston for 2 or more than 2 years, but not more than 3 years of time
Beschrijving

Date Randomization | Status post Intake Tamoxifen | Status post Intake Fareston

Datatype

boolean

Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0034656
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1512806
UMLS CUI [2,3]
C0039286
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C1512806
UMLS CUI [3,3]
C0600382
8. patients taking neo-chemotherapy are eligible, and lymph node status could be identified during surgery before neo-adjuvant chemotherapy or after neo-adjuvant chemotherapy. the definition of lymph node positive is:
Beschrijving

Chemotherapy Neoadjuvant | Lymph nodes Status

Datatype

boolean

Alias
UMLS CUI [1,1]
C0392920
UMLS CUI [1,2]
C0600558
UMLS CUI [2,1]
C0024204
UMLS CUI [2,2]
C0449438
evaluation of lymph node status before neo-adjuvant chemotherapy must include pathological axillary nodes, internal mammary nodes (pn2b option) or supraclavicular nodes (pn3c option) involved. micro-metastasis (i.e.≥0.2mm, pn1-pn3c) can be identified by the following method: fine needle aspiration (fna) or sentinel node biopsy (snb) or sampling/ total procedure of axillary dissection
Beschrijving

Evaluation Lymph node Status | Axillary lymph nodes Pathological | Internal mammary node TNM Breast tumor staging | Supraclavicular lymph node TNM Breast tumor staging | Neoplasm Micrometastasis TNM Breast tumor staging | Fine needle aspiration | Sentinel Lymph Node Biopsy | Excision of axillary lymph nodes

Datatype

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C0024204
UMLS CUI [1,3]
C0449438
UMLS CUI [2,1]
C0729594
UMLS CUI [2,2]
C1521733
UMLS CUI [3,1]
C0447180
UMLS CUI [3,2]
C0474926
UMLS CUI [4,1]
C0229730
UMLS CUI [4,2]
C0474926
UMLS CUI [5,1]
C1513276
UMLS CUI [5,2]
C0474926
UMLS CUI [6]
C1510483
UMLS CUI [7]
C0796693
UMLS CUI [8]
C0193867
patients with no nodes positive after neo-adjuvant chemotherapy, lymph node positive must be evaluated during surgery. its definition was the either of following:
Beschrijving

Lymph node positive Absent | Lymph node positive Evaluation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0746319
UMLS CUI [1,2]
C0332197
UMLS CUI [2,1]
C0746319
UMLS CUI [2,2]
C1261322
according the clinical practice guidelines of the local cancer center, it is acceptable when positive nodes was identified by snb or axillary dissection
Beschrijving

Lymph node positive Sentinel Lymph Node Biopsy | Lymph node positive Excision of axillary lymph nodes

Datatype

boolean

Alias
UMLS CUI [1,1]
C0746319
UMLS CUI [1,2]
C0796693
UMLS CUI [2,1]
C0746319
UMLS CUI [2,2]
C0193867
there is pathological evidence in lymph nodes positive (pn1-pn3c) during breast surgery after neo-adjuvant chemotherapy
Beschrijving

Lymph node positive TNM Breast tumor staging | Operation on breast | Chemotherapy Neoadjuvant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0746319
UMLS CUI [1,2]
C0474926
UMLS CUI [2]
C3714726
UMLS CUI [3,1]
C0392920
UMLS CUI [3,2]
C0600558
9. patients diagnosed as occult breast cancer clinically are found to pathologically have primary invasive carcinoma or dcis with micro-invasive lesion in ipsilateral breast, and primary lesion or axillary node metastasis express er and/or pr positive
Beschrijving

Breast Carcinoma Occult | Invasive Carcinoma Primary | DCIS | Microinvasive lesion Breast Ipsilateral | Primary Lesion Estrogen receptor positive | Primary Lesion Progesterone receptor positive | AXILLARY LYMPH NODE METASTASIS Estrogen receptor positive | AXILLARY LYMPH NODE METASTASIS Progesterone receptor positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205262
UMLS CUI [2,1]
C1334274
UMLS CUI [2,2]
C0205225
UMLS CUI [3]
C0007124
UMLS CUI [4,1]
C0205622
UMLS CUI [4,2]
C0006141
UMLS CUI [4,3]
C0441989
UMLS CUI [5,1]
C1402294
UMLS CUI [5,2]
C0279754
UMLS CUI [6,1]
C1402294
UMLS CUI [6,2]
C0279759
UMLS CUI [7,1]
C0741344
UMLS CUI [7,2]
C0279754
UMLS CUI [8,1]
C0741344
UMLS CUI [8,2]
C0279759
10. patients with synchronous bilateral cancers are eligible on the condition that if one side is idc and the other side is dcis, the idc side should be of the er and/or pr positive phenotype and if two sides are both idc, they must be er and/or pr positive phenotype at the same time
Beschrijving

Bilateral Carcinoma Synchronous | Invasive Ductal Carcinoma | DCIS | Invasive Ductal Carcinoma Estrogen receptor positive | Invasive Ductal Carcinoma Progesterone receptor positive

Datatype

boolean

Alias
UMLS CUI [1,1]
C1332549
UMLS CUI [1,2]
C0439580
UMLS CUI [2]
C1134719
UMLS CUI [3]
C0007124
UMLS CUI [4,1]
C1134719
UMLS CUI [4,2]
C0279754
UMLS CUI [5,1]
C1134719
UMLS CUI [5,2]
C0279759
11. hormone receptor positive (≥＋) is defined as detecting er or pr expression at any time is eligible. the situation of only pr positive and er negative is eligible, too
Beschrijving

Hormone Receptor Positive | Estrogen receptor positive | Progesterone receptor positive | Estrogen receptor negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019929
UMLS CUI [1,2]
C1514241
UMLS CUI [2]
C0279754
UMLS CUI [3]
C0279759
UMLS CUI [4]
C0279756
12. according to the standard operation principles for clinical practice of local cancer center, patients must be randomized within 4 weeks after definitive physical examination, imaging examination and laboratory testing show no evidence of recurrence or metastasis
Beschrijving

Randomization | Disease recurrence Absent Physical Examination | Neoplasm Metastasis Absent Physical Examination | Disease recurrence Absent Diagnostic Imaging | Neoplasm Metastasis Absent Diagnostic Imaging | Disease recurrence Absent Laboratory Procedures | Neoplasm Metastasis Absent Laboratory Procedures

Datatype

boolean

Alias
UMLS CUI [1]
C0034656
UMLS CUI [2,1]
C0679254
UMLS CUI [2,2]
C0332197
UMLS CUI [2,3]
C0031809
UMLS CUI [3,1]
C0027627
UMLS CUI [3,2]
C0332197
UMLS CUI [3,3]
C0031809
UMLS CUI [4,1]
C0679254
UMLS CUI [4,2]
C0332197
UMLS CUI [4,3]
C0011923
UMLS CUI [5,1]
C0027627
UMLS CUI [5,2]
C0332197
UMLS CUI [5,3]
C0011923
UMLS CUI [6,1]
C0679254
UMLS CUI [6,2]
C0332197
UMLS CUI [6,3]
C0022885
UMLS CUI [7,1]
C0027627
UMLS CUI [7,2]
C0332197
UMLS CUI [7,3]
C0022885
13. based on the study objective, all patients are required to be premenopausal as defined by
Beschrijving

Premenopausal state

Datatype

boolean

Alias
UMLS CUI [1]
C0232969
menstruating actively
Beschrijving

Menstruation

Datatype

boolean

Alias
UMLS CUI [1]
C0025344
less than 6 months since last menstrual period (lmp), or patients younger than 40 years of age who became amenorrheic not more than 1 year if the serum free e2、fsh and lh level was premenopausal (according to the reference value of local center).
Beschrijving

Menstruation Last | Age | Amenorrhea | Estradiol measurement Premenopausal state | Follicle stimulating hormone measurement Premenopausal state | Luteinizing hormone measurement Premenopausal state

Datatype

boolean

Alias
UMLS CUI [1,1]
C0025344
UMLS CUI [1,2]
C1517741
UMLS CUI [2]
C0001779
UMLS CUI [3]
C0002453
UMLS CUI [4,1]
C0337434
UMLS CUI [4,2]
C0232969
UMLS CUI [5,1]
C0202022
UMLS CUI [5,2]
C0232969
UMLS CUI [6,1]
C0202123
UMLS CUI [6,2]
C0232969
had previous hysterectomy with one or both ovaries left intact are eligible if the serum free e2、fsh and lh level are premenopausal (according to the reference value of local center).
Beschrijving

Hysterectomy | Ovary Quantity Intact | Estradiol measurement Premenopausal state | Follicle stimulating hormone measurement Premenopausal state | Luteinizing hormone measurement Premenopausal state

Datatype

boolean

Alias
UMLS CUI [1]
C0020699
UMLS CUI [2,1]
C0029939
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0205266
UMLS CUI [3,1]
C0337434
UMLS CUI [3,2]
C0232969
UMLS CUI [4,1]
C0202022
UMLS CUI [4,2]
C0232969
UMLS CUI [5,1]
C0202123
UMLS CUI [5,2]
C0232969
14. patients must have an ecog performance status of 0 or 1 (0-fully active, able to carry on all pre-disease performance without restriction, 1-restricted in physical strenuous actively but ambulatory)
Beschrijving

ECOG performance status

Datatype

boolean

Alias
UMLS CUI [1]
C1520224
15. leucocyte count must be ≥3.0*10^9/l and platelet count must be ≥100*10^9/l
Beschrijving

White Blood Cell Count procedure | Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
UMLS CUI [2]
C0032181
16. ast/sgot or alt/agpt must be <3 times the uln
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
17. serum creatinine must be <2 times the uln
Beschrijving

Creatinine measurement, serum

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
18. patients can swallow pills
Beschrijving

Able to swallow Pills

Datatype

boolean

Alias
UMLS CUI [1,1]
C2712086
UMLS CUI [1,2]
C0994475
19. pregnancy testing is negative and are willing to do contraception during the treatment period
Beschrijving

Pregnancy test negative | Contraceptive methods Willing

Datatype

boolean

Alias
UMLS CUI [1]
C0427780
UMLS CUI [2,1]
C0700589
UMLS CUI [2,2]
C0600109
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with metastatic malignant tumor
Beschrijving

Neoplasm Metastasis

Datatype

boolean

Alias
UMLS CUI [1]
C0027627
2. previous history of asynchronous bilateral breast cancer
Beschrijving

Bilateral breast cancer Asynchronous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0281267
UMLS CUI [1,2]
C0439581
3. any previous malignancy in the past 5 years, except for those treated with curative intent, such as carcinoma in situ of the cervix, squamous carcinoma of the skin or basal cell carcinoma of the skin
Beschrijving

Malignant Neoplasms | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Basal cell carcinoma

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C1273390
UMLS CUI [2,3]
C0851140
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C1273390
UMLS CUI [3,3]
C0553723
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1273390
UMLS CUI [4,3]
C0007117
4. any non-malignant systemic disease which interfere long time follow up
Beschrijving

Systemic disease Interferes with Follow-up Long-term

Datatype

boolean

Alias
UMLS CUI [1,1]
C0442893
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C3274571
UMLS CUI [1,4]
C0443252
5. history of medical ovarian ablation therapy
Beschrijving

Ovarian ablation

Datatype

boolean

Alias
UMLS CUI [1]
C0677922
6. history of ai therapy
Beschrijving

Aromatase Inhibitors

Datatype

boolean

Alias
UMLS CUI [1]
C0593802
7. severe live dysfunction, child－pugh is grade c
Beschrijving

Liver Dysfunction Severe Child-Pugh Clinical Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C4050412
8. occult breast cancer is found pathologically no idc lesion or only dcis without micro-invasive lesion in the ipsilateral breast
Beschrijving

Breast Carcinoma Occult Pathological | Invasive Ductal Carcinoma Absent | DCIS | Absence Microinvasive lesion Breast Ipsilateral

Datatype

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205262
UMLS CUI [1,3]
C1521733
UMLS CUI [2,1]
C1134719
UMLS CUI [2,2]
C0332197
UMLS CUI [3]
C0007124
UMLS CUI [4,1]
C0332197
UMLS CUI [4,2]
C0205622
UMLS CUI [4,3]
C0006141
UMLS CUI [4,4]
C0441989
9. patients with her-2 overexpression had used, or is using, or intending to use adjuvant trastuzumab
Beschrijving

HER-2 Overexpression | Trastuzumab Adjuvant

Datatype

boolean

Alias
UMLS CUI [1,1]
C0069515
UMLS CUI [1,2]
C1514559
UMLS CUI [2,1]
C0728747
UMLS CUI [2,2]
C1522673
10. severe heart dysfunction, heart functional classification is above class iii table 2 child-pugh score of hepatic cirrhosis
Beschrijving

Myocardial dysfunction Severe | Cardiac function Classification | Liver Cirrhosis Child-Pugh Clinical Classification

Datatype

boolean

Alias
UMLS CUI [1,1]
C0340515
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0232164
UMLS CUI [2,2]
C0008902
UMLS CUI [3,1]
C0023890
UMLS CUI [3,2]
C4050412
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Similar models

Eligibility Breast Cancer NCT01352091

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent
Item
1. all patients must have signed and dated an informed consent form
boolean
C0021430 (UMLS CUI [1])
Gender
Item
2. patients must be female
boolean
C0079399 (UMLS CUI [1])
Invasive carcinoma of breast Primary Core needle biopsy | Invasive carcinoma of breast Primary Incisional biopsy
Item
3. primary invasive breast cancer pathologically approved by core needle or open biopsy
boolean
C0853879 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1318309 (UMLS CUI [1,3])
C0853879 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0184922 (UMLS CUI [2,3])
Positive Axillary Lymph Node Ipsilateral TNM Breast tumor staging | Internal mammary node Positive TNM Breast tumor staging | Tumor size | Neoplasm Micrometastasis
Item
4. ipsilateral axillary or internal mammary nodes positive, or tumor size is equal to or larger than 4cm. definition of nodes positive is according to the staging system of ajcc 6th edition (american joint cancer commission) for breast carcinoma. the micrometastasis must be at least 0.2mm
boolean
C0677929 (UMLS CUI [1,1])
C0441989 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C0447180 (UMLS CUI [2,1])
C1514241 (UMLS CUI [2,2])
C0474926 (UMLS CUI [2,3])
C0475440 (UMLS CUI [3])
C1513276 (UMLS CUI [4])
Operative Surgical Procedures Breast Carcinoma Primary
Item
5. patients must have undergone standard surgery for primary breast cancer as shown in the following:
boolean
C0543467 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])
Mastectomy, Radical | Modified mastectomy
Item
a standard radical mastectomy or modified mastectomy
boolean
C0024884 (UMLS CUI [1])
C0024883 (UMLS CUI [2])
Breast-Conserving Surgery | Segmental Mastectomy | Quadrantectomy of breast | Excision of axillary lymph nodes | Negative Surgical Margin | Radiotherapy, Adjuvant | Adjuvant Chemotherapy Completed
Item
standard breast conservation surgery (bcs), which is lumpectomy or qaudrantectomy accompany with axillary dissection, and the surgical margins of the resected specimen must be negative. bcs must be followed by standardized adjuvant radiotherapy to the partial conserved breast (delivered after adjuvant chemotherapy completed)
boolean
C0917927 (UMLS CUI [1])
C0024885 (UMLS CUI [2])
C0337354 (UMLS CUI [3])
C0193867 (UMLS CUI [4])
C1709157 (UMLS CUI [5])
C0242939 (UMLS CUI [6])
C0085533 (UMLS CUI [7,1])
C0205197 (UMLS CUI [7,2])
Therapeutic procedure Breast Carcinoma | Operative Surgical Procedures | Therapeutic radiology procedure Local-Regional | Segmental Mastectomy | Adjuvant Radiotherapy Chest wall | Adjuvant Radiotherapy Internal mammary node | Adjuvant Radiotherapy supraclavicular lymph node | Chemotherapy, Adjuvant
Item
treatment for confirmed breast cancer including the surgery modality listed above, loco-regional radiotherapy after lumpectomy, adjuvant radiotherapy to the chest wall and/or internal mammary nodes and/or supraclavicular lymph nodes, adjuvant chemotherapy
boolean
C0087111 (UMLS CUI [1,1])
C0678222 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2])
C1522449 (UMLS CUI [3,1])
C1947913 (UMLS CUI [3,2])
C0024885 (UMLS CUI [4])
C0242939 (UMLS CUI [5,1])
C0205076 (UMLS CUI [5,2])
C0242939 (UMLS CUI [6,1])
C0447180 (UMLS CUI [6,2])
C0242939 (UMLS CUI [7,1])
C0229730 (UMLS CUI [7,2])
C0085533 (UMLS CUI [8])
Hormone Therapy Adjuvant | Tamoxifen | Fareston
Item
6. adjuvant endocrine therapy of tam or fareston must be started within 6 weeks when adjuvant chemotherapy or radiotherapy was finished
boolean
C0279025 (UMLS CUI [1,1])
C1522673 (UMLS CUI [1,2])
C0039286 (UMLS CUI [2])
C0600382 (UMLS CUI [3])
Date Randomization | Status post Intake Tamoxifen | Status post Intake Fareston
Item
7. the date of randomization must be processed after taking tam or fareston for 2 or more than 2 years, but not more than 3 years of time
boolean
C0011008 (UMLS CUI [1,1])
C0034656 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1512806 (UMLS CUI [2,2])
C0039286 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C1512806 (UMLS CUI [3,2])
C0600382 (UMLS CUI [3,3])
Chemotherapy Neoadjuvant | Lymph nodes Status
Item
8. patients taking neo-chemotherapy are eligible, and lymph node status could be identified during surgery before neo-adjuvant chemotherapy or after neo-adjuvant chemotherapy. the definition of lymph node positive is:
boolean
C0392920 (UMLS CUI [1,1])
C0600558 (UMLS CUI [1,2])
C0024204 (UMLS CUI [2,1])
C0449438 (UMLS CUI [2,2])
Evaluation Lymph node Status | Axillary lymph nodes Pathological | Internal mammary node TNM Breast tumor staging | Supraclavicular lymph node TNM Breast tumor staging | Neoplasm Micrometastasis TNM Breast tumor staging | Fine needle aspiration | Sentinel Lymph Node Biopsy | Excision of axillary lymph nodes
Item
evaluation of lymph node status before neo-adjuvant chemotherapy must include pathological axillary nodes, internal mammary nodes (pn2b option) or supraclavicular nodes (pn3c option) involved. micro-metastasis (i.e.≥0.2mm, pn1-pn3c) can be identified by the following method: fine needle aspiration (fna) or sentinel node biopsy (snb) or sampling/ total procedure of axillary dissection
boolean
C1261322 (UMLS CUI [1,1])
C0024204 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0729594 (UMLS CUI [2,1])
C1521733 (UMLS CUI [2,2])
C0447180 (UMLS CUI [3,1])
C0474926 (UMLS CUI [3,2])
C0229730 (UMLS CUI [4,1])
C0474926 (UMLS CUI [4,2])
C1513276 (UMLS CUI [5,1])
C0474926 (UMLS CUI [5,2])
C1510483 (UMLS CUI [6])
C0796693 (UMLS CUI [7])
C0193867 (UMLS CUI [8])
Lymph node positive Absent | Lymph node positive Evaluation
Item
patients with no nodes positive after neo-adjuvant chemotherapy, lymph node positive must be evaluated during surgery. its definition was the either of following:
boolean
C0746319 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0746319 (UMLS CUI [2,1])
C1261322 (UMLS CUI [2,2])
Lymph node positive Sentinel Lymph Node Biopsy | Lymph node positive Excision of axillary lymph nodes
Item
according the clinical practice guidelines of the local cancer center, it is acceptable when positive nodes was identified by snb or axillary dissection
boolean
C0746319 (UMLS CUI [1,1])
C0796693 (UMLS CUI [1,2])
C0746319 (UMLS CUI [2,1])
C0193867 (UMLS CUI [2,2])
Lymph node positive TNM Breast tumor staging | Operation on breast | Chemotherapy Neoadjuvant
Item
there is pathological evidence in lymph nodes positive (pn1-pn3c) during breast surgery after neo-adjuvant chemotherapy
boolean
C0746319 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C3714726 (UMLS CUI [2])
C0392920 (UMLS CUI [3,1])
C0600558 (UMLS CUI [3,2])
Breast Carcinoma Occult | Invasive Carcinoma Primary | DCIS | Microinvasive lesion Breast Ipsilateral | Primary Lesion Estrogen receptor positive | Primary Lesion Progesterone receptor positive | AXILLARY LYMPH NODE METASTASIS Estrogen receptor positive | AXILLARY LYMPH NODE METASTASIS Progesterone receptor positive
Item
9. patients diagnosed as occult breast cancer clinically are found to pathologically have primary invasive carcinoma or dcis with micro-invasive lesion in ipsilateral breast, and primary lesion or axillary node metastasis express er and/or pr positive
boolean
C0678222 (UMLS CUI [1,1])
C0205262 (UMLS CUI [1,2])
C1334274 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C0007124 (UMLS CUI [3])
C0205622 (UMLS CUI [4,1])
C0006141 (UMLS CUI [4,2])
C0441989 (UMLS CUI [4,3])
C1402294 (UMLS CUI [5,1])
C0279754 (UMLS CUI [5,2])
C1402294 (UMLS CUI [6,1])
C0279759 (UMLS CUI [6,2])
C0741344 (UMLS CUI [7,1])
C0279754 (UMLS CUI [7,2])
C0741344 (UMLS CUI [8,1])
C0279759 (UMLS CUI [8,2])
Bilateral Carcinoma Synchronous | Invasive Ductal Carcinoma | DCIS | Invasive Ductal Carcinoma Estrogen receptor positive | Invasive Ductal Carcinoma Progesterone receptor positive
Item
10. patients with synchronous bilateral cancers are eligible on the condition that if one side is idc and the other side is dcis, the idc side should be of the er and/or pr positive phenotype and if two sides are both idc, they must be er and/or pr positive phenotype at the same time
boolean
C1332549 (UMLS CUI [1,1])
C0439580 (UMLS CUI [1,2])
C1134719 (UMLS CUI [2])
C0007124 (UMLS CUI [3])
C1134719 (UMLS CUI [4,1])
C0279754 (UMLS CUI [4,2])
C1134719 (UMLS CUI [5,1])
C0279759 (UMLS CUI [5,2])
Hormone Receptor Positive | Estrogen receptor positive | Progesterone receptor positive | Estrogen receptor negative
Item
11. hormone receptor positive (≥＋) is defined as detecting er or pr expression at any time is eligible. the situation of only pr positive and er negative is eligible, too
boolean
C0019929 (UMLS CUI [1,1])
C1514241 (UMLS CUI [1,2])
C0279754 (UMLS CUI [2])
C0279759 (UMLS CUI [3])
C0279756 (UMLS CUI [4])
Randomization | Disease recurrence Absent Physical Examination | Neoplasm Metastasis Absent Physical Examination | Disease recurrence Absent Diagnostic Imaging | Neoplasm Metastasis Absent Diagnostic Imaging | Disease recurrence Absent Laboratory Procedures | Neoplasm Metastasis Absent Laboratory Procedures
Item
12. according to the standard operation principles for clinical practice of local cancer center, patients must be randomized within 4 weeks after definitive physical examination, imaging examination and laboratory testing show no evidence of recurrence or metastasis
boolean
C0034656 (UMLS CUI [1])
C0679254 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0031809 (UMLS CUI [2,3])
C0027627 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0031809 (UMLS CUI [3,3])
C0679254 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0011923 (UMLS CUI [4,3])
C0027627 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0011923 (UMLS CUI [5,3])
C0679254 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0022885 (UMLS CUI [6,3])
C0027627 (UMLS CUI [7,1])
C0332197 (UMLS CUI [7,2])
C0022885 (UMLS CUI [7,3])
Premenopausal state
Item
13. based on the study objective, all patients are required to be premenopausal as defined by
boolean
C0232969 (UMLS CUI [1])
Menstruation
Item
menstruating actively
boolean
C0025344 (UMLS CUI [1])
Menstruation Last | Age | Amenorrhea | Estradiol measurement Premenopausal state | Follicle stimulating hormone measurement Premenopausal state | Luteinizing hormone measurement Premenopausal state
Item
less than 6 months since last menstrual period (lmp), or patients younger than 40 years of age who became amenorrheic not more than 1 year if the serum free e2、fsh and lh level was premenopausal (according to the reference value of local center).
boolean
C0025344 (UMLS CUI [1,1])
C1517741 (UMLS CUI [1,2])
C0001779 (UMLS CUI [2])
C0002453 (UMLS CUI [3])
C0337434 (UMLS CUI [4,1])
C0232969 (UMLS CUI [4,2])
C0202022 (UMLS CUI [5,1])
C0232969 (UMLS CUI [5,2])
C0202123 (UMLS CUI [6,1])
C0232969 (UMLS CUI [6,2])
Hysterectomy | Ovary Quantity Intact | Estradiol measurement Premenopausal state | Follicle stimulating hormone measurement Premenopausal state | Luteinizing hormone measurement Premenopausal state
Item
had previous hysterectomy with one or both ovaries left intact are eligible if the serum free e2、fsh and lh level are premenopausal (according to the reference value of local center).
boolean
C0020699 (UMLS CUI [1])
C0029939 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0205266 (UMLS CUI [2,3])
C0337434 (UMLS CUI [3,1])
C0232969 (UMLS CUI [3,2])
C0202022 (UMLS CUI [4,1])
C0232969 (UMLS CUI [4,2])
C0202123 (UMLS CUI [5,1])
C0232969 (UMLS CUI [5,2])
ECOG performance status
Item
14. patients must have an ecog performance status of 0 or 1 (0-fully active, able to carry on all pre-disease performance without restriction, 1-restricted in physical strenuous actively but ambulatory)
boolean
C1520224 (UMLS CUI [1])
White Blood Cell Count procedure | Platelet Count measurement
Item
15. leucocyte count must be ≥3.0*10^9/l and platelet count must be ≥100*10^9/l
boolean
C0023508 (UMLS CUI [1])
C0032181 (UMLS CUI [2])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
16. ast/sgot or alt/agpt must be <3 times the uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum
Item
17. serum creatinine must be <2 times the uln
boolean
C0201976 (UMLS CUI [1])
Able to swallow Pills
Item
18. patients can swallow pills
boolean
C2712086 (UMLS CUI [1,1])
C0994475 (UMLS CUI [1,2])
Pregnancy test negative | Contraceptive methods Willing
Item
19. pregnancy testing is negative and are willing to do contraception during the treatment period
boolean
C0427780 (UMLS CUI [1])
C0700589 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Neoplasm Metastasis
Item
1. patients with metastatic malignant tumor
boolean
C0027627 (UMLS CUI [1])
Bilateral breast cancer Asynchronous
Item
2. previous history of asynchronous bilateral breast cancer
boolean
C0281267 (UMLS CUI [1,1])
C0439581 (UMLS CUI [1,2])
Malignant Neoplasms | Exception Curative treatment Carcinoma in situ of uterine cervix | Exception Curative treatment Squamous cell carcinoma of skin | Exception Curative treatment Basal cell carcinoma
Item
3. any previous malignancy in the past 5 years, except for those treated with curative intent, such as carcinoma in situ of the cervix, squamous carcinoma of the skin or basal cell carcinoma of the skin
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C1273390 (UMLS CUI [2,2])
C0851140 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C1273390 (UMLS CUI [3,2])
C0553723 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1273390 (UMLS CUI [4,2])
C0007117 (UMLS CUI [4,3])
Systemic disease Interferes with Follow-up Long-term
Item
4. any non-malignant systemic disease which interfere long time follow up
boolean
C0442893 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
C0443252 (UMLS CUI [1,4])
Ovarian ablation
Item
5. history of medical ovarian ablation therapy
boolean
C0677922 (UMLS CUI [1])
Aromatase Inhibitors
Item
6. history of ai therapy
boolean
C0593802 (UMLS CUI [1])
Liver Dysfunction Severe Child-Pugh Clinical Classification
Item
7. severe live dysfunction, child－pugh is grade c
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C4050412 (UMLS CUI [1,3])
Breast Carcinoma Occult Pathological | Invasive Ductal Carcinoma Absent | DCIS | Absence Microinvasive lesion Breast Ipsilateral
Item
8. occult breast cancer is found pathologically no idc lesion or only dcis without micro-invasive lesion in the ipsilateral breast
boolean
C0678222 (UMLS CUI [1,1])
C0205262 (UMLS CUI [1,2])
C1521733 (UMLS CUI [1,3])
C1134719 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0007124 (UMLS CUI [3])
C0332197 (UMLS CUI [4,1])
C0205622 (UMLS CUI [4,2])
C0006141 (UMLS CUI [4,3])
C0441989 (UMLS CUI [4,4])
HER-2 Overexpression | Trastuzumab Adjuvant
Item
9. patients with her-2 overexpression had used, or is using, or intending to use adjuvant trastuzumab
boolean
C0069515 (UMLS CUI [1,1])
C1514559 (UMLS CUI [1,2])
C0728747 (UMLS CUI [2,1])
C1522673 (UMLS CUI [2,2])
Myocardial dysfunction Severe | Cardiac function Classification | Liver Cirrhosis Child-Pugh Clinical Classification
Item
10. severe heart dysfunction, heart functional classification is above class iii table 2 child-pugh score of hepatic cirrhosis
boolean
C0340515 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0232164 (UMLS CUI [2,1])
C0008902 (UMLS CUI [2,2])
C0023890 (UMLS CUI [3,1])
C4050412 (UMLS CUI [3,2])
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