ID

14888

Description

A Phase I Study of a Therapeutic Vaccine Candidate in Patients With Localized Breast Cancer at High-Risk of Relapse; ODM derived from: https://clinicaltrials.gov/show/NCT02364492

Link

https://clinicaltrials.gov/show/NCT02364492

Keywords

Versions (1)
  1. 5/4/16 5/4/16 -
Uploaded on

May 4, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Breast Neoplasms NCT02364492

English

Eligibility Breast Neoplasms NCT02364492

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. all patients must have a diagnosis of epithelial breast carcinoma which is, according to tnm classification:
Description

Breast Carcinoma epithelial | TNM category

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0221908
UMLS CUI [2]
C0809869
any t
Description

T - Tumor stage

Data type

boolean

Alias
UMLS CUI [1]
C0475455
with positive (n+) or negative (n-) lymph-node depending on the patient profile
Description

N+ (tumor staging) | N Stage | lymph nodes

Data type

boolean

Alias
UMLS CUI [1]
C0441922
UMLS CUI [2]
C0456532
UMLS CUI [3]
C0024204
and non metastatic (m0)
Description

M0 category

Data type

boolean

Alias
UMLS CUI [1]
C0445034
2. her2/neu-negative (immunohistochemical expression "0-1+", and/or fish/cish "non amplified" according to asco 2012 criteria)
Description

Human epidermal growth factor 2 negative carcinoma of breast | Immunohistochemistry | Fluorescent in Situ Hybridization | Chromogenic in situ Hybridization | American Society of Clinical Oncology diagnostic criteria

Data type

boolean

Alias
UMLS CUI [1]
C2316304
UMLS CUI [2]
C0021044
UMLS CUI [3]
C0162789
UMLS CUI [4]
C1516514
UMLS CUI [5,1]
C1515948
UMLS CUI [5,2]
C0679228
3. first line treatment population with a high-risk of relapse as defined by:
Description

First line treatment Population Group | High risk of Relapse

Data type

boolean

Alias
UMLS CUI [1,1]
C1708063
UMLS CUI [1,2]
C1257890
UMLS CUI [2,1]
C0332167
UMLS CUI [2,2]
C0035020
with at least 4 positive lymph nodes (ln) at primary surgery, or at least one positive lymph node >pn1mi after completion of 6-8 cycles of anthracyclins/taxanes-based neoadjuvant chemotherapy
Description

lymph node positive | Operative Surgical Procedures Primary | Lymph node positive (1-3 positive nodes) pN1mi category | Neoadjuvant Therapy Chemotherapy | Anthracyclines | Taxanes, antineoplastic

Data type

boolean

Alias
UMLS CUI [1]
C0746319
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0205225
UMLS CUI [3,1]
C4035698
UMLS CUI [3,2]
C2732831
UMLS CUI [4,1]
C0600558
UMLS CUI [4,2]
C3665472
UMLS CUI [5]
C0282564
UMLS CUI [6]
C3541958
or, negative hormone receptors: er- and pr- , (<10%), i.e "triple negative breast cancer" with at least one positive lymph node >pn1mi or negative lymph node if a pathological complete remission was not achieved (persistence of invasive carcinoma) after completion of 6-8 cycles of anthracyclins/taxanes-based neoadjuvant chemotherapy
Description

Triple-Negative Breast Cancer Finding | Lymph node positive (1-3 positive nodes) pN1mi category | Negative Lymph Node | In complete remission | Invasive Carcinoma persistent | Neoadjuvant Therapy Chemotherapy | Anthracyclines | Taxanes, antineoplastic

Data type

boolean

Alias
UMLS CUI [1]
C2348819
UMLS CUI [2,1]
C4035698
UMLS CUI [2,2]
C2732831
UMLS CUI [3]
C0678034
UMLS CUI [4]
C0677874
UMLS CUI [5,1]
C1334274
UMLS CUI [5,2]
C0205322
UMLS CUI [6,1]
C0600558
UMLS CUI [6,2]
C3665472
UMLS CUI [7]
C0282564
UMLS CUI [8]
C3541958
4. patients must have completed all their local and regional treatments including adequate surgery and radiation therapy, and at least 6 cycles of chemotherapy (neoadjuvant and/or adjuvant) according to institutional and national standards.
Description

Complete Therapeutic procedure Operative Surgical Procedures Therapeutic radiology procedure | Neoadjuvant Therapy Chemotherapy | Chemotherapy, Adjuvant

Data type

boolean

Alias
UMLS CUI [1,1]
C0205197
UMLS CUI [1,2]
C0087111
UMLS CUI [1,3]
C0543467
UMLS CUI [1,4]
C1522449
UMLS CUI [2,1]
C0600558
UMLS CUI [2,2]
C3665472
UMLS CUI [3]
C0085533
5. the time interval between the end of all the first line standard treatment (completion of surgery, chemotherapy and radiation therapy) should be at least 3 months and within a maximum of 18 months before inclusion in the study.
Description

Time Interval | First line treatment | Complete Operative Surgical Procedures Chemotherapy Regimen Therapeutic radiology procedure

Data type

boolean

Alias
UMLS CUI [1]
C0872291
UMLS CUI [2]
C1708063
UMLS CUI [3,1]
C0205197
UMLS CUI [3,2]
C0543467
UMLS CUI [3,3]
C0392920
UMLS CUI [3,4]
C1522449
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. any breast cancer recurrence or metastasis.
Description

Breast Carcinoma Recurrence | Breast Carcinoma Neoplasm Metastasis

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0034897
UMLS CUI [2,1]
C0678222
UMLS CUI [2,2]
C0027627
2. patients with her2/neu positive breast carcinoma (ihc score 2+ or 3+ and/or fish/cish-amplified).
Description

HER2-positive carcinoma of breast | Immunohistochemistry Score | Fluorescent in Situ Hybridization | Chromogenic in situ Hybridization

Data type

boolean

Alias
UMLS CUI [1]
C1960398
UMLS CUI [2,1]
C0021044
UMLS CUI [2,2]
C0449820
UMLS CUI [3]
C0162789
UMLS CUI [4]
C1516514
3. patients with any uncontrolled bleeding disorder including coagulation disorder or thrombocytopenia or prothrombotic disorder.
Description

Bleeding uncontrolled | Blood Coagulation Disorders | Thrombocytopenia | Thrombosis

Data type

boolean

Alias
UMLS CUI [1]
C3842135
UMLS CUI [2]
C0005779
UMLS CUI [3]
C0040034
UMLS CUI [4]
C0040053
4. patients with a personal history of autoimmune disease (including but not limited to multiple sclerosis, lupus, rheumatoid polyarthritis, inflammatory bowel diseases, graves' disease and hashimoto's disease).
Description

Autoimmune Diseases | Multiple Sclerosis | Lupus Erythematosus | rheumatoid; polyarthritis | Inflammatory Bowel Diseases | Graves Disease | Hashimoto Disease

Data type

boolean

Alias
UMLS CUI [1]
C0004364
UMLS CUI [2]
C0026769
UMLS CUI [3]
C0409974
UMLS CUI [4]
C1405320
UMLS CUI [5]
C0021390
UMLS CUI [6]
C0018213
UMLS CUI [7]
C0677607
5. patients with a history of previous anaphylaxis or severe allergic reaction to vaccines or other known or unknown allergens.
Description

anaphylaxis Vaccines | Hypersensitivity Vaccines | anaphylaxis Allergens | Hypersensitivity Allergens

Data type

boolean

Alias
UMLS CUI [1,1]
C0002792
UMLS CUI [1,2]
C0042210
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0042210
UMLS CUI [3,1]
C0002792
UMLS CUI [3,2]
C0002092
UMLS CUI [4,1]
C0020517
UMLS CUI [4,2]
C0002092
6. patients who have received any commercial vaccine within one month before the first dose of study vaccine or are planned to receive any vaccine till 3 weeks after the 6th vaccine injection.
Description

Vaccines commercial | Vaccines Clinical Research | Vaccines

Data type

boolean

Alias
UMLS CUI [1,1]
C0042210
UMLS CUI [1,2]
C0680536
UMLS CUI [2,1]
C0042210
UMLS CUI [2,2]
C0008972
UMLS CUI [3]
C0042210
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Similar models

Eligibility Breast Neoplasms NCT02364492

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Breast Carcinoma epithelial | TNM category
Item
1. all patients must have a diagnosis of epithelial breast carcinoma which is, according to tnm classification:
boolean
C0678222 (UMLS CUI [1,1])
C0221908 (UMLS CUI [1,2])
C0809869 (UMLS CUI [2])
T - Tumor stage
Item
any t
boolean
C0475455 (UMLS CUI [1])
N+ (tumor staging) | N Stage | lymph nodes
Item
with positive (n+) or negative (n-) lymph-node depending on the patient profile
boolean
C0441922 (UMLS CUI [1])
C0456532 (UMLS CUI [2])
C0024204 (UMLS CUI [3])
M0 category
Item
and non metastatic (m0)
boolean
C0445034 (UMLS CUI [1])
Human epidermal growth factor 2 negative carcinoma of breast | Immunohistochemistry | Fluorescent in Situ Hybridization | Chromogenic in situ Hybridization | American Society of Clinical Oncology diagnostic criteria
Item
2. her2/neu-negative (immunohistochemical expression "0-1+", and/or fish/cish "non amplified" according to asco 2012 criteria)
boolean
C2316304 (UMLS CUI [1])
C0021044 (UMLS CUI [2])
C0162789 (UMLS CUI [3])
C1516514 (UMLS CUI [4])
C1515948 (UMLS CUI [5,1])
C0679228 (UMLS CUI [5,2])
First line treatment Population Group | High risk of Relapse
Item
3. first line treatment population with a high-risk of relapse as defined by:
boolean
C1708063 (UMLS CUI [1,1])
C1257890 (UMLS CUI [1,2])
C0332167 (UMLS CUI [2,1])
C0035020 (UMLS CUI [2,2])
lymph node positive | Operative Surgical Procedures Primary | Lymph node positive (1-3 positive nodes) pN1mi category | Neoadjuvant Therapy Chemotherapy | Anthracyclines | Taxanes, antineoplastic
Item
with at least 4 positive lymph nodes (ln) at primary surgery, or at least one positive lymph node >pn1mi after completion of 6-8 cycles of anthracyclins/taxanes-based neoadjuvant chemotherapy
boolean
C0746319 (UMLS CUI [1])
C0543467 (UMLS CUI [2,1])
C0205225 (UMLS CUI [2,2])
C4035698 (UMLS CUI [3,1])
C2732831 (UMLS CUI [3,2])
C0600558 (UMLS CUI [4,1])
C3665472 (UMLS CUI [4,2])
C0282564 (UMLS CUI [5])
C3541958 (UMLS CUI [6])
Triple-Negative Breast Cancer Finding | Lymph node positive (1-3 positive nodes) pN1mi category | Negative Lymph Node | In complete remission | Invasive Carcinoma persistent | Neoadjuvant Therapy Chemotherapy | Anthracyclines | Taxanes, antineoplastic
Item
or, negative hormone receptors: er- and pr- , (<10%), i.e "triple negative breast cancer" with at least one positive lymph node >pn1mi or negative lymph node if a pathological complete remission was not achieved (persistence of invasive carcinoma) after completion of 6-8 cycles of anthracyclins/taxanes-based neoadjuvant chemotherapy
boolean
C2348819 (UMLS CUI [1])
C4035698 (UMLS CUI [2,1])
C2732831 (UMLS CUI [2,2])
C0678034 (UMLS CUI [3])
C0677874 (UMLS CUI [4])
C1334274 (UMLS CUI [5,1])
C0205322 (UMLS CUI [5,2])
C0600558 (UMLS CUI [6,1])
C3665472 (UMLS CUI [6,2])
C0282564 (UMLS CUI [7])
C3541958 (UMLS CUI [8])
Complete Therapeutic procedure Operative Surgical Procedures Therapeutic radiology procedure | Neoadjuvant Therapy Chemotherapy | Chemotherapy, Adjuvant
Item
4. patients must have completed all their local and regional treatments including adequate surgery and radiation therapy, and at least 6 cycles of chemotherapy (neoadjuvant and/or adjuvant) according to institutional and national standards.
boolean
C0205197 (UMLS CUI [1,1])
C0087111 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C1522449 (UMLS CUI [1,4])
C0600558 (UMLS CUI [2,1])
C3665472 (UMLS CUI [2,2])
C0085533 (UMLS CUI [3])
Time Interval | First line treatment | Complete Operative Surgical Procedures Chemotherapy Regimen Therapeutic radiology procedure
Item
5. the time interval between the end of all the first line standard treatment (completion of surgery, chemotherapy and radiation therapy) should be at least 3 months and within a maximum of 18 months before inclusion in the study.
boolean
C0872291 (UMLS CUI [1])
C1708063 (UMLS CUI [2])
C0205197 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0392920 (UMLS CUI [3,3])
C1522449 (UMLS CUI [3,4])
Item Group
C0680251 (UMLS CUI)
Breast Carcinoma Recurrence | Breast Carcinoma Neoplasm Metastasis
Item
1. any breast cancer recurrence or metastasis.
boolean
C0678222 (UMLS CUI [1,1])
C0034897 (UMLS CUI [1,2])
C0678222 (UMLS CUI [2,1])
C0027627 (UMLS CUI [2,2])
HER2-positive carcinoma of breast | Immunohistochemistry Score | Fluorescent in Situ Hybridization | Chromogenic in situ Hybridization
Item
2. patients with her2/neu positive breast carcinoma (ihc score 2+ or 3+ and/or fish/cish-amplified).
boolean
C1960398 (UMLS CUI [1])
C0021044 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
C0162789 (UMLS CUI [3])
C1516514 (UMLS CUI [4])
Bleeding uncontrolled | Blood Coagulation Disorders | Thrombocytopenia | Thrombosis
Item
3. patients with any uncontrolled bleeding disorder including coagulation disorder or thrombocytopenia or prothrombotic disorder.
boolean
C3842135 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
C0040034 (UMLS CUI [3])
C0040053 (UMLS CUI [4])
Autoimmune Diseases | Multiple Sclerosis | Lupus Erythematosus | rheumatoid; polyarthritis | Inflammatory Bowel Diseases | Graves Disease | Hashimoto Disease
Item
4. patients with a personal history of autoimmune disease (including but not limited to multiple sclerosis, lupus, rheumatoid polyarthritis, inflammatory bowel diseases, graves' disease and hashimoto's disease).
boolean
C0004364 (UMLS CUI [1])
C0026769 (UMLS CUI [2])
C0409974 (UMLS CUI [3])
C1405320 (UMLS CUI [4])
C0021390 (UMLS CUI [5])
C0018213 (UMLS CUI [6])
C0677607 (UMLS CUI [7])
anaphylaxis Vaccines | Hypersensitivity Vaccines | anaphylaxis Allergens | Hypersensitivity Allergens
Item
5. patients with a history of previous anaphylaxis or severe allergic reaction to vaccines or other known or unknown allergens.
boolean
C0002792 (UMLS CUI [1,1])
C0042210 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0042210 (UMLS CUI [2,2])
C0002792 (UMLS CUI [3,1])
C0002092 (UMLS CUI [3,2])
C0020517 (UMLS CUI [4,1])
C0002092 (UMLS CUI [4,2])
Vaccines commercial | Vaccines Clinical Research | Vaccines
Item
6. patients who have received any commercial vaccine within one month before the first dose of study vaccine or are planned to receive any vaccine till 3 weeks after the 6th vaccine injection.
boolean
C0042210 (UMLS CUI [1,1])
C0680536 (UMLS CUI [1,2])
C0042210 (UMLS CUI [2,1])
C0008972 (UMLS CUI [2,2])
C0042210 (UMLS CUI [3])
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