ID

38337

Description

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

Link

https://clinicaltrials.gov/show/NCT01864798

Keywords

Versions (1)
  1. 10/11/19 10/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

October 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT01864798

English

Eligibility Breast Neoplasms NCT01864798

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. female gender
Description

Gender

Data type

boolean

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

Age

Data type

boolean

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

ECOG performance status

Data type

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
Description

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

Data type

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:
Description

Invasive carcinoma of breast Newly Diagnosed Operable | Neoplasm Metastasis Absent

Data type

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
Description

Confirmation Histology

Data type

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
Description

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

Data type

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
Description

Lymph nodal status Any

Data type

boolean

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

Invasive carcinoma of breast Operable

Data type

boolean

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

HER2 Status Known

Data type

boolean

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

Estrogen Receptor Status Known | Progesterone Receptor Status Known

Data type

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:
Description

Bone Marrow function | Organ function

Data type

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
Description

Absolute neutrophil count

Data type

boolean

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

Platelet Count measurement

Data type

boolean

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

Hemoglobin measurement

Data type

boolean

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

Creatinine measurement, serum

Data type

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)
Description

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

Data type

boolean

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

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Data type

boolean

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

Random blood glucose measurement

Data type

boolean

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

Hemoglobin A1c measurement

Data type

boolean

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

Serum calcium measurement Corrected for albumin

Data type

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
Description

Childbearing Potential Contraceptive methods

Data type

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
Description

Calcium supplement therapy | Vitamin D supplementation

Data type

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
Description

Informed Consent

Data type

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.
Description

Availability of Tumor tissue sample | Availability of Tissue specimen Normal

Data type

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
Description

Exclusion Criteria

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

Breast Carcinoma Previous Ipsilateral | Breast Carcinoma Previous Contralateral

Data type

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
Description

Neoplasm TNM clinical staging | Inflammatory Breast Carcinoma

Data type

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)
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

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

Data type

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
Description

Hepatitis B | Hepatitis C | HIV Infection

Data type

boolean

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

Hypersensitivity Denosumab

Data type

boolean

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

Bilateral Carcinoma Invasive

Data type

boolean

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

Eligibility Breast Neoplasms NCT01864798

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
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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