ID

35103

Beschrijving

Neoadjuvant MEDI4736 Concomitant With Weekly Nab-paclitaxel and Dose-dense AC for Stage I-III Triple Negative Breast Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT02489448

Link

https://clinicaltrials.gov/show/NCT02489448

Trefwoorden

Versies (1)
  1. 17-02-19 17-02-19 -
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See clinicaltrials.gov

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17 februari 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02489448

Engels

Eligibility Breast Neoplasms NCT02489448

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. newly diagnosed histologically confirmed stage i-iii, er, pr and her2 negative invasive breast cancer as defined by the asco cap guidelines for whom systemic chemotherapy would be indicated based on physician judgment following standard nccn practice guidelines.
Beschrijving

Triple Negative Breast Neoplasm Invasive TNM Breast tumor staging | Indication Systemic Chemotherapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C3539878
UMLS CUI [1,2]
C0205281
UMLS CUI [1,3]
C0474926
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1883256
2. willing and able to provide written informed consent for voluntary participation in the trial.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
3. willing to undergo a baseline tumor core needle biopsy and blood draws for correlative science studies.
Beschrijving

Neoplasm Core needle biopsy | Blood draw | Correlative Study

Datatype

boolean

Alias
UMLS CUI [1,1]
C0027651
UMLS CUI [1,2]
C1318309
UMLS CUI [2]
C0005834
UMLS CUI [3]
C1511524
4. eighteen years of age or older on the day of signing informed consent.
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
5. female subjects must either be of non-reproductive potential or must have a negative urine or serum pregnancy test upon study entry.
Beschrijving

Female infertility | Urine pregnancy test negative | Serum pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1]
C0021361
UMLS CUI [2]
C0430057
UMLS CUI [3]
C0430061
6. patients should have adequate organ function to tolerate chemotherapy, as defined by:
Beschrijving

Organ function | Chemotherapy Receive

Datatype

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0392920
UMLS CUI [2,2]
C1514756
peripheral granulocyte count of > 1,500/mm3
Beschrijving

Granulocyte count Peripheral blood

Datatype

boolean

Alias
UMLS CUI [1,1]
C0857490
UMLS CUI [1,2]
C0229664
platelet count > 100,000/mm3
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
hemoglobin >9 g/dl
Beschrijving

Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
total bilirubin < 1.5 x upper limit of normal (uln)
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
aspartate aminotransferase (ast) and alanine aminotransferase (alt) each < 1.5 x uln
Beschrijving

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201899
UMLS CUI [2]
C0201836
serum creatinine < 1.5 x uln or serum creatinine clearance < 50ml/min
Beschrijving

Creatinine measurement, serum | Creatinine clearance measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
inr/pt/ptt each < 1.5 x uln
Beschrijving

International Normalized Ratio | Prothrombin time assay | Activated Partial Thromboplastin Time measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0525032
UMLS CUI [2]
C0033707
UMLS CUI [3]
C0030605
tsh within normal limits
Beschrijving

Thyroid stimulating hormone normal

Datatype

boolean

Alias
UMLS CUI [1]
C0858305
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who underwent partial excisional biopsy or lumpectomy, segmental mastectomy or modified radical mastectomy or sentinel node.
Beschrijving

Excision biopsy Partial | Segmental Mastectomy | Modified radical mastectomy | Sentinel Lymph Node Biopsy

Datatype

boolean

Alias
UMLS CUI [1,1]
C0184921
UMLS CUI [1,2]
C0728938
UMLS CUI [2]
C0024885
UMLS CUI [3]
C0024883
UMLS CUI [4]
C0796693
2. patients for whom anthracycline, paclitaxel or antibody therapies are contraindicated.
Beschrijving

Medical contraindication Anthracyclines | Medical contraindication Paclitaxel | Medical contraindication Antibody therapy

Datatype

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0282564
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0144576
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0281176
3. patients with active autoimmune disease or documented autoimmune disease within 2 years. patients with hypothyroidism that is clinically stable and have normal tsh levels with hormone replacement, or patients with vitiligo or psoriasis not requiring treatment remain eligible for the study.
Beschrijving

Autoimmune Disease | Patients Eligible | Hypothyroidism Stable | Serum TSH level normal | Hormone replacement therapy | Vitiligo | Psoriasis | Lacking Requirement Therapeutic procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548635
UMLS CUI [3,1]
C0020676
UMLS CUI [3,2]
C0205360
UMLS CUI [4]
C0580433
UMLS CUI [5]
C0282402
UMLS CUI [6]
C0042900
UMLS CUI [7]
C0033860
UMLS CUI [8,1]
C0332268
UMLS CUI [8,2]
C1514873
UMLS CUI [8,3]
C0087111
4. active or prior documented inflammatory bowel disease (crohn's disease, ulcerative colitis).
Beschrijving

Inflammatory Bowel Disease | Crohn Disease | Ulcerative Colitis

Datatype

boolean

Alias
UMLS CUI [1]
C0021390
UMLS CUI [2]
C0010346
UMLS CUI [3]
C0009324
5. patients with known active hepatitis b or c or hiv infection or with history of tuberculosis.
Beschrijving

Hepatitis B | Hepatitis C | HIV Infection | Tuberculosis

Datatype

boolean

Alias
UMLS CUI [1]
C0019163
UMLS CUI [2]
C0019196
UMLS CUI [3]
C0019693
UMLS CUI [4]
C0041296
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Similar models

Eligibility Breast Neoplasms NCT02489448

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Triple Negative Breast Neoplasm Invasive TNM Breast tumor staging | Indication Systemic Chemotherapy
Item
1. newly diagnosed histologically confirmed stage i-iii, er, pr and her2 negative invasive breast cancer as defined by the asco cap guidelines for whom systemic chemotherapy would be indicated based on physician judgment following standard nccn practice guidelines.
boolean
C3539878 (UMLS CUI [1,1])
C0205281 (UMLS CUI [1,2])
C0474926 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C1883256 (UMLS CUI [2,2])
Informed Consent
Item
2. willing and able to provide written informed consent for voluntary participation in the trial.
boolean
C0021430 (UMLS CUI [1])
Neoplasm Core needle biopsy | Blood draw | Correlative Study
Item
3. willing to undergo a baseline tumor core needle biopsy and blood draws for correlative science studies.
boolean
C0027651 (UMLS CUI [1,1])
C1318309 (UMLS CUI [1,2])
C0005834 (UMLS CUI [2])
C1511524 (UMLS CUI [3])
Age
Item
4. eighteen years of age or older on the day of signing informed consent.
boolean
C0001779 (UMLS CUI [1])
Female infertility | Urine pregnancy test negative | Serum pregnancy test negative
Item
5. female subjects must either be of non-reproductive potential or must have a negative urine or serum pregnancy test upon study entry.
boolean
C0021361 (UMLS CUI [1])
C0430057 (UMLS CUI [2])
C0430061 (UMLS CUI [3])
Organ function | Chemotherapy Receive
Item
6. patients should have adequate organ function to tolerate chemotherapy, as defined by:
boolean
C0678852 (UMLS CUI [1])
C0392920 (UMLS CUI [2,1])
C1514756 (UMLS CUI [2,2])
Granulocyte count Peripheral blood
Item
peripheral granulocyte count of > 1,500/mm3
boolean
C0857490 (UMLS CUI [1,1])
C0229664 (UMLS CUI [1,2])
Platelet Count measurement
Item
platelet count > 100,000/mm3
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
hemoglobin >9 g/dl
boolean
C0518015 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin < 1.5 x upper limit of normal (uln)
boolean
C1278039 (UMLS CUI [1])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement
Item
aspartate aminotransferase (ast) and alanine aminotransferase (alt) each < 1.5 x uln
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
Creatinine measurement, serum | Creatinine clearance measurement
Item
serum creatinine < 1.5 x uln or serum creatinine clearance < 50ml/min
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
International Normalized Ratio | Prothrombin time assay | Activated Partial Thromboplastin Time measurement
Item
inr/pt/ptt each < 1.5 x uln
boolean
C0525032 (UMLS CUI [1])
C0033707 (UMLS CUI [2])
C0030605 (UMLS CUI [3])
Thyroid stimulating hormone normal
Item
tsh within normal limits
boolean
C0858305 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Excision biopsy Partial | Segmental Mastectomy | Modified radical mastectomy | Sentinel Lymph Node Biopsy
Item
1. patients who underwent partial excisional biopsy or lumpectomy, segmental mastectomy or modified radical mastectomy or sentinel node.
boolean
C0184921 (UMLS CUI [1,1])
C0728938 (UMLS CUI [1,2])
C0024885 (UMLS CUI [2])
C0024883 (UMLS CUI [3])
C0796693 (UMLS CUI [4])
Medical contraindication Anthracyclines | Medical contraindication Paclitaxel | Medical contraindication Antibody therapy
Item
2. patients for whom anthracycline, paclitaxel or antibody therapies are contraindicated.
boolean
C1301624 (UMLS CUI [1,1])
C0282564 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0144576 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0281176 (UMLS CUI [3,2])
Autoimmune Disease | Patients Eligible | Hypothyroidism Stable | Serum TSH level normal | Hormone replacement therapy | Vitiligo | Psoriasis | Lacking Requirement Therapeutic procedure
Item
3. patients with active autoimmune disease or documented autoimmune disease within 2 years. patients with hypothyroidism that is clinically stable and have normal tsh levels with hormone replacement, or patients with vitiligo or psoriasis not requiring treatment remain eligible for the study.
boolean
C0004364 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C1548635 (UMLS CUI [2,2])
C0020676 (UMLS CUI [3,1])
C0205360 (UMLS CUI [3,2])
C0580433 (UMLS CUI [4])
C0282402 (UMLS CUI [5])
C0042900 (UMLS CUI [6])
C0033860 (UMLS CUI [7])
C0332268 (UMLS CUI [8,1])
C1514873 (UMLS CUI [8,2])
C0087111 (UMLS CUI [8,3])
Inflammatory Bowel Disease | Crohn Disease | Ulcerative Colitis
Item
4. active or prior documented inflammatory bowel disease (crohn's disease, ulcerative colitis).
boolean
C0021390 (UMLS CUI [1])
C0010346 (UMLS CUI [2])
C0009324 (UMLS CUI [3])
Hepatitis B | Hepatitis C | HIV Infection | Tuberculosis
Item
5. patients with known active hepatitis b or c or hiv infection or with history of tuberculosis.
boolean
C0019163 (UMLS CUI [1])
C0019196 (UMLS CUI [2])
C0019693 (UMLS CUI [3])
C0041296 (UMLS CUI [4])
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