ID

37942

Descripción

A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Patients With HER2-Positive Breast Cancer Who Relapsed After (Neo)Adjuvant Herceptin Treatment; ODM derived from: https://clinicaltrials.gov/show/NCT01301729

Link

https://clinicaltrials.gov/show/NCT01301729

Palabras clave

Versiones (1)
  1. 2/9/19 2/9/19 -
Titular de derechos de autor

See clinicaltrials.gov

Subido en

2 de septiembre de 2019

DOI

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Licencia

Creative Commons BY 4.0
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Eligibility Breast Cancer NCT01301729

Inglés

Eligibility Breast Cancer NCT01301729

1 formularios  
Inclusion Criteria
Descripción

Inclusion Criteria

Alias
UMLS CUI
C1512693
female patients, >/= 18 years of age
Descripción

Gender | Age

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0001779
locally recurrent/metastatic breast cancer (relapse in supra- or infraclavicular lymph nodes is regarded as metastatic disease)
Descripción

Breast cancer recurrent Locally | Secondary malignant neoplasm of female breast

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0278493
UMLS CUI [1,2]
C1517927
UMLS CUI [2]
C0346993
her2-positive primary disease
Descripción

Disease HER2 Positive

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C2348909
patients must have received herceptin in the adjuvant and/or neoadjuvant setting
Descripción

Herceptin | Adjuvant therapy | Neoadjuvant Therapy

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0338204
UMLS CUI [2]
C0677850
UMLS CUI [3]
C0600558
relapsed breast cancer >/= 6 months after discontinuing last drugs of herceptin and/or chemotherapy in the adjuvant and/or neoadjuvant setting for her2-positive breast cancer
Descripción

Breast cancer recurrent | Status post Herceptin Discontinuation | Status post Adjuvant Chemotherapy | Status post Neoadjuvant Chemotherapy | HER2-positive carcinoma of breast

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0278493
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0338204
UMLS CUI [2,3]
C1444662
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0085533
UMLS CUI [4,1]
C0231290
UMLS CUI [4,2]
C0600558
UMLS CUI [4,3]
C3665472
UMLS CUI [5]
C1960398
measurable disease according to recist 1.0
Descripción

Measurable Disease

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1513041
eastern cooperative oncology group (ecog) performance status 0-2
Descripción

ECOG performance status

Tipo de datos

boolean

Alias
UMLS CUI [1]
C1520224
maximum cumulative dose of doxorubicin </= 360 mg/m2 or of epirubicin </= 720 mg/m2 or no prior anthracyclines
Descripción

Doxorubicin Cumulative Dose Maximum | Epirubicin Cumulative Dose Maximum | Anthracyclines Absent

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0013089
UMLS CUI [1,2]
C2986497
UMLS CUI [1,3]
C0806909
UMLS CUI [2,1]
C0014582
UMLS CUI [2,2]
C2986497
UMLS CUI [2,3]
C0806909
UMLS CUI [3,1]
C0282564
UMLS CUI [3,2]
C0332197
at least 3 weeks after prior surgery or radiotherapy
Descripción

Operative Surgical Procedure Previous | Prior radiation therapy

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0205156
UMLS CUI [2]
C0279134
Exclusion Criteria
Descripción

Exclusion Criteria

Alias
UMLS CUI
C0680251
pregnant or breastfeeding women
Descripción

Pregnancy | Breast Feeding

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
previous chemotherapy for metastatic breast cancer (prior endocrine therapy till progressive disease is allowed)
Descripción

Prior Chemotherapy Secondary malignant neoplasm of female breast

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C1514457
UMLS CUI [1,2]
C0346993
pleural effusions, ascites or bone lesions as only manifestation of disease
Descripción

Pleural effusion disorder | Ascites | Bone lesion

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0032227
UMLS CUI [2]
C0003962
UMLS CUI [3]
C0238792
brain metastases
Descripción

Metastatic malignant neoplasm to brain

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0220650
invasive malignancy other than metastatic breast cancer
Descripción

Invasive cancer | Exception Secondary malignant neoplasm of female breast

Tipo de datos

boolean

Alias
UMLS CUI [1]
C0677898
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0346993
inadequate bone marrow, hepatic or renal function
Descripción

Bone Marrow function Inadequate | Liver function Inadequate | Renal function Inadequate

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C0005953
UMLS CUI [1,2]
C0031843
UMLS CUI [1,3]
C0205412
UMLS CUI [2,1]
C0232741
UMLS CUI [2,2]
C0205412
UMLS CUI [3,1]
C0232804
UMLS CUI [3,2]
C0205412
prior treatment with anti-her therapies other than (neo)adjuvant herceptin
Descripción

HER Receptors Targeted Therapy | Exception Herceptin Neo-adjuvant

Tipo de datos

boolean

Alias
UMLS CUI [1,1]
C3812393
UMLS CUI [1,2]
C2985566
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0338204
UMLS CUI [2,3]
C1298676
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Similar models

Eligibility Breast Cancer NCT01301729

1 formularios
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de datos
Alias
Item Group
C1512693 (UMLS CUI)
Gender | Age
Item
female patients, >/= 18 years of age
boolean
C0079399 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Breast cancer recurrent Locally | Secondary malignant neoplasm of female breast
Item
locally recurrent/metastatic breast cancer (relapse in supra- or infraclavicular lymph nodes is regarded as metastatic disease)
boolean
C0278493 (UMLS CUI [1,1])
C1517927 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2])
Disease HER2 Positive
Item
her2-positive primary disease
boolean
C0012634 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
Herceptin | Adjuvant therapy | Neoadjuvant Therapy
Item
patients must have received herceptin in the adjuvant and/or neoadjuvant setting
boolean
C0338204 (UMLS CUI [1])
C0677850 (UMLS CUI [2])
C0600558 (UMLS CUI [3])
Breast cancer recurrent | Status post Herceptin Discontinuation | Status post Adjuvant Chemotherapy | Status post Neoadjuvant Chemotherapy | HER2-positive carcinoma of breast
Item
relapsed breast cancer >/= 6 months after discontinuing last drugs of herceptin and/or chemotherapy in the adjuvant and/or neoadjuvant setting for her2-positive breast cancer
boolean
C0278493 (UMLS CUI [1])
C0231290 (UMLS CUI [2,1])
C0338204 (UMLS CUI [2,2])
C1444662 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0085533 (UMLS CUI [3,2])
C0231290 (UMLS CUI [4,1])
C0600558 (UMLS CUI [4,2])
C3665472 (UMLS CUI [4,3])
C1960398 (UMLS CUI [5])
Measurable Disease
Item
measurable disease according to recist 1.0
boolean
C1513041 (UMLS CUI [1])
ECOG performance status
Item
eastern cooperative oncology group (ecog) performance status 0-2
boolean
C1520224 (UMLS CUI [1])
Doxorubicin Cumulative Dose Maximum | Epirubicin Cumulative Dose Maximum | Anthracyclines Absent
Item
maximum cumulative dose of doxorubicin </= 360 mg/m2 or of epirubicin </= 720 mg/m2 or no prior anthracyclines
boolean
C0013089 (UMLS CUI [1,1])
C2986497 (UMLS CUI [1,2])
C0806909 (UMLS CUI [1,3])
C0014582 (UMLS CUI [2,1])
C2986497 (UMLS CUI [2,2])
C0806909 (UMLS CUI [2,3])
C0282564 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Operative Surgical Procedure Previous | Prior radiation therapy
Item
at least 3 weeks after prior surgery or radiotherapy
boolean
C0543467 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0279134 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Prior Chemotherapy Secondary malignant neoplasm of female breast
Item
previous chemotherapy for metastatic breast cancer (prior endocrine therapy till progressive disease is allowed)
boolean
C1514457 (UMLS CUI [1,1])
C0346993 (UMLS CUI [1,2])
Pleural effusion disorder | Ascites | Bone lesion
Item
pleural effusions, ascites or bone lesions as only manifestation of disease
boolean
C0032227 (UMLS CUI [1])
C0003962 (UMLS CUI [2])
C0238792 (UMLS CUI [3])
Metastatic malignant neoplasm to brain
Item
brain metastases
boolean
C0220650 (UMLS CUI [1])
Invasive cancer | Exception Secondary malignant neoplasm of female breast
Item
invasive malignancy other than metastatic breast cancer
boolean
C0677898 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0346993 (UMLS CUI [2,2])
Bone Marrow function Inadequate | Liver function Inadequate | Renal function Inadequate
Item
inadequate bone marrow, hepatic or renal function
boolean
C0005953 (UMLS CUI [1,1])
C0031843 (UMLS CUI [1,2])
C0205412 (UMLS CUI [1,3])
C0232741 (UMLS CUI [2,1])
C0205412 (UMLS CUI [2,2])
C0232804 (UMLS CUI [3,1])
C0205412 (UMLS CUI [3,2])
HER Receptors Targeted Therapy | Exception Herceptin Neo-adjuvant
Item
prior treatment with anti-her therapies other than (neo)adjuvant herceptin
boolean
C3812393 (UMLS CUI [1,1])
C2985566 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0338204 (UMLS CUI [2,2])
C1298676 (UMLS CUI [2,3])
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