ID

35103

Beskrivning

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

Länk

https://clinicaltrials.gov/show/NCT02489448

Nyckelord

Versioner (1)
  1. 2019-02-17 2019-02-17 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

17 februari 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02489448

Engelsk

Eligibility Breast Neoplasms NCT02489448

1 Formulär  
Inclusion Criteria
Beskrivning

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.
Beskrivning

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

Datatyp

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.
Beskrivning

Informed Consent

Datatyp

boolean

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

Neoplasm Core needle biopsy | Blood draw | Correlative Study

Datatyp

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.
Beskrivning

Age

Datatyp

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.
Beskrivning

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

Datatyp

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:
Beskrivning

Organ function | Chemotherapy Receive

Datatyp

boolean

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

Granulocyte count Peripheral blood

Datatyp

boolean

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

Platelet Count measurement

Datatyp

boolean

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

Hemoglobin measurement

Datatyp

boolean

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

Serum total bilirubin measurement

Datatyp

boolean

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

Aspartate aminotransferase measurement | Alanine aminotransferase measurement

Datatyp

boolean

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

Creatinine measurement, serum | Creatinine clearance measurement

Datatyp

boolean

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

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

Datatyp

boolean

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

Thyroid stimulating hormone normal

Datatyp

boolean

Alias
UMLS CUI [1]
C0858305
Exclusion Criteria
Beskrivning

Exclusion Criteria

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

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

Datatyp

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.
Beskrivning

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

Datatyp

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.
Beskrivning

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

Datatyp

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).
Beskrivning

Inflammatory Bowel Disease | Crohn Disease | Ulcerative Colitis

Datatyp

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.
Beskrivning

Hepatitis B | Hepatitis C | HIV Infection | Tuberculosis

Datatyp

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 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
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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