ID

38337

Descrizione

A Study to Evaluate Denosumab in Young Patients With Primary Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT01864798

collegamento

https://clinicaltrials.gov/show/NCT01864798

Keywords

versioni (1)
  1. 11/10/19 11/10/19 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

11 ottobre 2019

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01864798

Inglese

Eligibility Breast Neoplasms NCT01864798

1 moduli  
Inclusion Criteria
Descrizione

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female gender
Descrizione

Gender

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0079399
2. age ≥ 18 years
Descrizione

Age

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0001779
3. eastern cooperative oncology group (ecog) performance status 0 or 1
Descrizione

ECOG performance status

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1520224
4. premenopausal status defined as the presence of active menstrual cycle or normal menses during the 6 weeks preceding the start of study treatment. biochemical evidence of phase of menstrual cycle is required (estradiol, fsh and lh). in women previously exposed to hysterectomy,or were using hormonal intrauterine device at the time of enrolment, premenopausal levels of estradiol, fsh and lh are required to be eligible
Descrizione

Premenopausal state | Menstrual cycle Estradiol measurement | Menstrual cycle Follicle stimulating hormone measurement | Menstrual cycle Luteinizing hormone measurement | Hysterectomy | Use of Intrauterine Devices

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0232969
UMLS CUI [2,1]
C0025329
UMLS CUI [2,2]
C0337434
UMLS CUI [3,1]
C0025329
UMLS CUI [3,2]
C0202022
UMLS CUI [4,1]
C0025329
UMLS CUI [4,2]
C0202123
UMLS CUI [5]
C0020699
UMLS CUI [6,1]
C1524063
UMLS CUI [6,2]
C0021900
5. non-metastatic operable newly diagnosed primary invasive carcinoma of the breast that is:
Descrizione

Invasive carcinoma of breast Newly Diagnosed Operable | Neoplasm Metastasis Absent

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C1518321
UMLS CUI [1,3]
C0205188
UMLS CUI [2,1]
C0027627
UMLS CUI [2,2]
C0332197
1. histologically confirmed
Descrizione

Confirmation Histology

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0750484
UMLS CUI [1,2]
C0344441
2. primary tumor size greater than 1.5 cm, measured by any of clinical examination, mammography, ultrasound or magnetic resonance imaging
Descrizione

Tumor size Clinical examination | Tumor size Mammography | Tumor size Ultrasonography | Tumor size MRI

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0475440
UMLS CUI [1,2]
C1456356
UMLS CUI [2,1]
C0475440
UMLS CUI [2,2]
C0024671
UMLS CUI [3,1]
C0475440
UMLS CUI [3,2]
C0041618
UMLS CUI [4,1]
C0475440
UMLS CUI [4,2]
C0024485
3. any clinical nodal status
Descrizione

Lymph nodal status Any

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0449927
UMLS CUI [1,2]
C1552551
4. fully operable and not fixed to chest wall.
Descrizione

Invasive carcinoma of breast Operable

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205188
6. known her2 status
Descrizione

HER2 Status Known

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1512413
UMLS CUI [1,2]
C0205309
7. known estrogen receptor (er) status and progesterone receptor status (pgr)
Descrizione

Estrogen Receptor Status Known | Progesterone Receptor Status Known

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0034804
UMLS CUI [1,2]
C0449438
UMLS CUI [1,3]
C0205309
UMLS CUI [2,1]
C1514471
UMLS CUI [2,2]
C0205309
8. patient has adequate bone marrow and organ function as shown by:
Descrizione

Bone Marrow function | Organ function

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [2]
C0678852
absolute neutrophil count (anc) ≥ 1.5 x 109/l
Descrizione

Absolute neutrophil count

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0948762
platelets ≥ 100 x 109/l
Descrizione

Platelet Count measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin (hgb) ≥ 9.0 g/dl
Descrizione

Hemoglobin measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0518015
serum creatinine ≤ 1.5 x uln
Descrizione

Creatinine measurement, serum

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201976
total serum bilirubin ≤ 1.5 x uln (in patients with known gilbert syndrome, a total bilirubin ≤ 3.0 x uln, with direct bilirubin ≤ 1.5 x uln)
Descrizione

Serum total bilirubin measurement | Gilbert Disease | Bilirubin, direct measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0017551
UMLS CUI [3]
C0201916
ast and alt ≤ 1.5 x uln
Descrizione

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
random blood sugar (rbs) ≤ 200 mg/dl or ≤ 11.1 mmol/l
Descrizione

Random blood glucose measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0428567
glycosylated hemoglobin (hba1c) ≤ 8 %
Descrizione

Hemoglobin A1c measurement

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0474680
9. albumin-adjusted serum calcium ≥ 8.0 mg/dl (≥ 2.0 mmol/l)
Descrizione

Serum calcium measurement Corrected for albumin

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0728876
UMLS CUI [1,2]
C1439360
10. women of childbearing potential must agree to use an active local contraception method for the duration of the study and for at least 7 months after the last dose of study treatment
Descrizione

Childbearing Potential Contraceptive methods

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
11. patients must accept to take calcium and vitamin d supplementation until the completion of the study treatment
Descrizione

Calcium supplement therapy | Vitamin D supplementation

Tipo di dati

boolean

Alias
UMLS CUI [1]
C1096745
UMLS CUI [2]
C4524013
12. signed informed consent form (icf) for all study procedures according to local regulatory requirements prior to beginning of the study
Descrizione

Informed Consent

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0021430
13. patients must accept to make available tumor and normal tissue samples for submission to central laboratory at the jules bordet institute, brussels, belgium, to conduct translational studies as part of this protocol.
Descrizione

Availability of Tumor tissue sample | Availability of Tissue specimen Normal

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C0475358
UMLS CUI [2,1]
C0470187
UMLS CUI [2,2]
C1292533
UMLS CUI [2,3]
C0205307
Exclusion Criteria
Descrizione

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. history of any prior (ipsi and/or contralateral) breast cancer
Descrizione

Breast Carcinoma Previous Ipsilateral | Breast Carcinoma Previous Contralateral

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0441989
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0205156
UMLS CUI [2,3]
C0441988
2. any "clinical" t4 tumor defined by tnm including inflammatory breast cancer
Descrizione

Neoplasm TNM clinical staging | Inflammatory Breast Carcinoma

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C3258246
UMLS CUI [2]
C0278601
3. history of non-breast malignancies within the 5 years prior to study entry (except carcinoma in situ of the cervix, of the colon, melanoma in situ and basal cell and squamous cell carcinomas of the skin)
Descrizione

Malignant Neoplasms | Exception Breast Carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Colon Carcinoma In situ | Exception Malignant melanoma in situ | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0678222
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0851140
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C0699790
UMLS CUI [4,3]
C0444498
UMLS CUI [5,1]
C1705847
UMLS CUI [5,2]
C0854696
UMLS CUI [6,1]
C1705847
UMLS CUI [6,2]
C0007117
UMLS CUI [7,1]
C1705847
UMLS CUI [7,2]
C0553723
4. prior or planned systemic anti-cancer therapy before definitive surgery
Descrizione

Cancer treatment Systemic | Cancer treatment Systemic Planned | Status pre- Operative Surgical Procedure

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0920425
UMLS CUI [1,2]
C0205373
UMLS CUI [2,1]
C0920425
UMLS CUI [2,2]
C0205373
UMLS CUI [2,3]
C1301732
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C0543467
5. unhealed or planned dental/oral surgery, current or previous osteonecrosis or osteomyelitis of the jaw
Descrizione

Dental surgical procedure Non-healed | Oral Surgical Procedures Non-healed | Dental surgical procedure Planned | Oral Surgical Procedures Planned | Aseptic necrosis of bone of jaw | Osteomyelitis of jaw

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0204324
UMLS CUI [1,2]
C0205301
UMLS CUI [2,1]
C0524861
UMLS CUI [2,2]
C0205301
UMLS CUI [3,1]
C0204324
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0524861
UMLS CUI [4,2]
C1301732
UMLS CUI [5]
C2711248
UMLS CUI [6]
C0266968
6. pregnant or lactating women or women of childbearing potential without a negative serum or urinary pregnancy test within 7 days prior to starting study treatment; irrespective of the method of contraception used
Descrizione

Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative Absent | Childbearing Potential Urine pregnancy test negative Absent | Independent of Contraceptive methods

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0430061
UMLS CUI [3,3]
C0332197
UMLS CUI [4,1]
C3831118
UMLS CUI [4,2]
C0430057
UMLS CUI [4,3]
C0332197
UMLS CUI [5,1]
C0332291
UMLS CUI [5,2]
C0700589
7. active hepatitis-b virus (hbv), hepatitis-c virus (hcv) or human immunodeficiency virus (hiv) infection
Descrizione

Hepatitis B | Hepatitis C | HIV Infection

Tipo di dati

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
8. known hypersensitivity to denosumab
Descrizione

Hypersensitivity Denosumab

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C1690432
9. bilateral invasive tumors
Descrizione

Bilateral Carcinoma Invasive

Tipo di dati

boolean

Alias
UMLS CUI [1,1]
C1332549
UMLS CUI [1,2]
C0205281
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Similar models

Eligibility Breast Neoplasms NCT01864798

1 moduli
Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
Alias
Item Group
C1512693 (UMLS CUI)
Gender
Item
1. female gender
boolean
C0079399 (UMLS CUI [1])
Age
Item
2. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
3. eastern cooperative oncology group (ecog) performance status 0 or 1
boolean
C1520224 (UMLS CUI [1])
Premenopausal state | Menstrual cycle Estradiol measurement | Menstrual cycle Follicle stimulating hormone measurement | Menstrual cycle Luteinizing hormone measurement | Hysterectomy | Use of Intrauterine Devices
Item
4. premenopausal status defined as the presence of active menstrual cycle or normal menses during the 6 weeks preceding the start of study treatment. biochemical evidence of phase of menstrual cycle is required (estradiol, fsh and lh). in women previously exposed to hysterectomy,or were using hormonal intrauterine device at the time of enrolment, premenopausal levels of estradiol, fsh and lh are required to be eligible
boolean
C0232969 (UMLS CUI [1])
C0025329 (UMLS CUI [2,1])
C0337434 (UMLS CUI [2,2])
C0025329 (UMLS CUI [3,1])
C0202022 (UMLS CUI [3,2])
C0025329 (UMLS CUI [4,1])
C0202123 (UMLS CUI [4,2])
C0020699 (UMLS CUI [5])
C1524063 (UMLS CUI [6,1])
C0021900 (UMLS CUI [6,2])
Invasive carcinoma of breast Newly Diagnosed Operable | Neoplasm Metastasis Absent
Item
5. non-metastatic operable newly diagnosed primary invasive carcinoma of the breast that is:
boolean
C0853879 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C0205188 (UMLS CUI [1,3])
C0027627 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Confirmation Histology
Item
1. histologically confirmed
boolean
C0750484 (UMLS CUI [1,1])
C0344441 (UMLS CUI [1,2])
Tumor size Clinical examination | Tumor size Mammography | Tumor size Ultrasonography | Tumor size MRI
Item
2. primary tumor size greater than 1.5 cm, measured by any of clinical examination, mammography, ultrasound or magnetic resonance imaging
boolean
C0475440 (UMLS CUI [1,1])
C1456356 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2,1])
C0024671 (UMLS CUI [2,2])
C0475440 (UMLS CUI [3,1])
C0041618 (UMLS CUI [3,2])
C0475440 (UMLS CUI [4,1])
C0024485 (UMLS CUI [4,2])
Lymph nodal status Any
Item
3. any clinical nodal status
boolean
C0449927 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
Invasive carcinoma of breast Operable
Item
4. fully operable and not fixed to chest wall.
boolean
C0853879 (UMLS CUI [1,1])
C0205188 (UMLS CUI [1,2])
HER2 Status Known
Item
6. known her2 status
boolean
C1512413 (UMLS CUI [1,1])
C0205309 (UMLS CUI [1,2])
Estrogen Receptor Status Known | Progesterone Receptor Status Known
Item
7. known estrogen receptor (er) status and progesterone receptor status (pgr)
boolean
C0034804 (UMLS CUI [1,1])
C0449438 (UMLS CUI [1,2])
C0205309 (UMLS CUI [1,3])
C1514471 (UMLS CUI [2,1])
C0205309 (UMLS CUI [2,2])
Bone Marrow function | Organ function
Item
8. patient has adequate bone marrow and organ function as shown by:
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0678852 (UMLS CUI [2])
Absolute neutrophil count
Item
absolute neutrophil count (anc) ≥ 1.5 x 109/l
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelets ≥ 100 x 109/l
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin (hgb) ≥ 9.0 g/dl
boolean
C0518015 (UMLS CUI [1])
Creatinine measurement, serum
Item
serum creatinine ≤ 1.5 x uln
boolean
C0201976 (UMLS CUI [1])
Serum total bilirubin measurement | Gilbert Disease | Bilirubin, direct measurement
Item
total serum bilirubin ≤ 1.5 x uln (in patients with known gilbert syndrome, a total bilirubin ≤ 3.0 x uln, with direct bilirubin ≤ 1.5 x uln)
boolean
C1278039 (UMLS CUI [1])
C0017551 (UMLS CUI [2])
C0201916 (UMLS CUI [3])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
ast and alt ≤ 1.5 x uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Random blood glucose measurement
Item
random blood sugar (rbs) ≤ 200 mg/dl or ≤ 11.1 mmol/l
boolean
C0428567 (UMLS CUI [1])
Hemoglobin A1c measurement
Item
glycosylated hemoglobin (hba1c) ≤ 8 %
boolean
C0474680 (UMLS CUI [1])
Serum calcium measurement Corrected for albumin
Item
9. albumin-adjusted serum calcium ≥ 8.0 mg/dl (≥ 2.0 mmol/l)
boolean
C0728876 (UMLS CUI [1,1])
C1439360 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods
Item
10. women of childbearing potential must agree to use an active local contraception method for the duration of the study and for at least 7 months after the last dose of study treatment
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Calcium supplement therapy | Vitamin D supplementation
Item
11. patients must accept to take calcium and vitamin d supplementation until the completion of the study treatment
boolean
C1096745 (UMLS CUI [1])
C4524013 (UMLS CUI [2])
Informed Consent
Item
12. signed informed consent form (icf) for all study procedures according to local regulatory requirements prior to beginning of the study
boolean
C0021430 (UMLS CUI [1])
Availability of Tumor tissue sample | Availability of Tissue specimen Normal
Item
13. patients must accept to make available tumor and normal tissue samples for submission to central laboratory at the jules bordet institute, brussels, belgium, to conduct translational studies as part of this protocol.
boolean
C0470187 (UMLS CUI [1,1])
C0475358 (UMLS CUI [1,2])
C0470187 (UMLS CUI [2,1])
C1292533 (UMLS CUI [2,2])
C0205307 (UMLS CUI [2,3])
Item Group
C0680251 (UMLS CUI)
Breast Carcinoma Previous Ipsilateral | Breast Carcinoma Previous Contralateral
Item
1. history of any prior (ipsi and/or contralateral) breast cancer
boolean
C0678222 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0441989 (UMLS CUI [1,3])
C0678222 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0441988 (UMLS CUI [2,3])
Neoplasm TNM clinical staging | Inflammatory Breast Carcinoma
Item
2. any "clinical" t4 tumor defined by tnm including inflammatory breast cancer
boolean
C0027651 (UMLS CUI [1,1])
C3258246 (UMLS CUI [1,2])
C0278601 (UMLS CUI [2])
Malignant Neoplasms | Exception Breast Carcinoma | Exception Carcinoma in situ of uterine cervix | Exception Colon Carcinoma In situ | Exception Malignant melanoma in situ | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin
Item
3. history of non-breast malignancies within the 5 years prior to study entry (except carcinoma in situ of the cervix, of the colon, melanoma in situ and basal cell and squamous cell carcinomas of the skin)
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0678222 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0851140 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0699790 (UMLS CUI [4,2])
C0444498 (UMLS CUI [4,3])
C1705847 (UMLS CUI [5,1])
C0854696 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0007117 (UMLS CUI [6,2])
C1705847 (UMLS CUI [7,1])
C0553723 (UMLS CUI [7,2])
Cancer treatment Systemic | Cancer treatment Systemic Planned | Status pre- Operative Surgical Procedure
Item
4. prior or planned systemic anti-cancer therapy before definitive surgery
boolean
C0920425 (UMLS CUI [1,1])
C0205373 (UMLS CUI [1,2])
C0920425 (UMLS CUI [2,1])
C0205373 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C0332152 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
Dental surgical procedure Non-healed | Oral Surgical Procedures Non-healed | Dental surgical procedure Planned | Oral Surgical Procedures Planned | Aseptic necrosis of bone of jaw | Osteomyelitis of jaw
Item
5. unhealed or planned dental/oral surgery, current or previous osteonecrosis or osteomyelitis of the jaw
boolean
C0204324 (UMLS CUI [1,1])
C0205301 (UMLS CUI [1,2])
C0524861 (UMLS CUI [2,1])
C0205301 (UMLS CUI [2,2])
C0204324 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0524861 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C2711248 (UMLS CUI [5])
C0266968 (UMLS CUI [6])
Pregnancy | Breast Feeding | Childbearing Potential Serum pregnancy test negative Absent | Childbearing Potential Urine pregnancy test negative Absent | Independent of Contraceptive methods
Item
6. pregnant or lactating women or women of childbearing potential without a negative serum or urinary pregnancy test within 7 days prior to starting study treatment; irrespective of the method of contraception used
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0430061 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C3831118 (UMLS CUI [4,1])
C0430057 (UMLS CUI [4,2])
C0332197 (UMLS CUI [4,3])
C0332291 (UMLS CUI [5,1])
C0700589 (UMLS CUI [5,2])
Hepatitis B | Hepatitis C | HIV Infection
Item
7. active hepatitis-b virus (hbv), hepatitis-c virus (hcv) or human immunodeficiency virus (hiv) infection
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
Hypersensitivity Denosumab
Item
8. known hypersensitivity to denosumab
boolean
C0020517 (UMLS CUI [1,1])
C1690432 (UMLS CUI [1,2])
Bilateral Carcinoma Invasive
Item
9. bilateral invasive tumors
boolean
C1332549 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
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