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])
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])