Eligibility High Risk NCT00590785

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StudyEvent: Eligibility
1. Eligibility High Risk NCT00590785

Name

Type

Description | Question | Decode (Coded Value)

Data type

Alias

Criteria

Item Group

axillary dissection, lymph nodes

Item

patients must have undergone an axillary dissection, and at least 6 nodes must have een removed and examined. nodal involvement by tumor must be negative or must not xceed three positive nodes.

boolean

C0193867 (UMLS CUI [1])
C0024204 (UMLS CUI [2])

high-risk, chemotherapy indicated

Item

disease must be considered sufficiently high-risk by the investigator to justify the use of chemotherapy. to be eligible, disease must satisfy one of the following requirements:

boolean

C0684030 (UMLS CUI [1])
C0392920 (UMLS CUI [2])

er and pgr negative, tumor size

Item

1. tumor is both er negative and pgr negative and greater than 1.0 cm in greatest diameter. negative is defined as c 10 fmollmg cytosol protein if measured in these units; othennrise negative is defined according to institutional standards.

boolean

C2919271 (UMLS CUI [1])
C2919590 (UMLS CUI [2])
C0475440 (UMLS CUI [3])

tumor size

Item

2. tumor that is greater than 2.0 cm in greatest diameter irrespective of hormone receptor status (including unknown).

boolean

C0475440 (UMLS CUI [1])

Lymph node involvment

Item

3. tumor involves one to three axillary lymph nodes.

boolean

C0392920 (UMLS CUI [1])

tumor stage

Item

breast cancer was not locally advanced at diagnosis. this is left to investigator judgement, but generally should exclude patients with fixed tumors, fixed nodes, peau d'orange skin changes, skin ulcerations or inflammatory changes (t4 disease).

boolean

C1300072 (UMLS CUI [1])

no evidence of breast cancer, criteria for bilateral breast cancer

Item

patient is currently free of breast cancer (no evidence of disease). this is also left to investigator judgement, but generally should include no evidence of distant disease on chest x-ray or mgmmogram of the opposite breast prior to registration, within 3 months prior to surgery; and no gross or microscopically positive surgical margins noted in the final surgery or pathology reports. patients with synchronous bilateral breast cancer may be considered, provided both breasts are treated with curative intent and that eligibility is based on the side with the most adverse prognostic features.

boolean

C0678222 (UMLS CUI [1,1])
C0687702 (UMLS CUI [1,2])
C0281267 (UMLS CUI [2])

time since mastectomy and axillary dissection, breast sparing surgery required, prior (chemo)therapy

Item

registration must be within 84 days of mastectomy, or within 84 days of axillary dissection if the patient's most extensive breast surgery was a breast sparing procedure. patients not having mastectomy or breast sparing surgery are ineligible. patients must not have had prior chemotherapy for this breast cancer. patients must not have had systemic therapy of any type for a previous breast cancer.

boolean

C0011008 (UMLS CUI [1])
C0024881 (UMLS CUI [2])
C0193867 (UMLS CUI [3])
C0917927 (UMLS CUI [4])
C0392920 (UMLS CUI [5])
C1514463 (UMLS CUI [6])

prior radiotherapy

Item

patients must not have had external beam radiotherapy for this breast cancer prior to registration. brachytherapy (interstitial radiation therapy) at the time of breast sparing procedure is acceptable and would not render the patient ineligible. (if external beam radiotherapy is planned to be given with brachytherapy, it must be delayed until after chemotherapy is complete.) patients whose most extensive breast surgery was a breast sparing procedure must be planning to receive radiotherapy after chemotherapy is complete.

boolean

C1522449 (UMLS CUI [1])
C0419095 (UMLS CUI [2])
C0006098 (UMLS CUI [3])
C0917927 (UMLS CUI [4])

health status, wbc, neutrophil count, platelet count, lvef and comorbidities

Item

patients must have adequate hematologic, hepatic, renal and cardiac function for high dose chemotherapy and adequate health for long-term follow-up. this must include normal wbc (2 4,0001pl). neutrophll count (2 1,50o/pl), platelet count (2 institutional lower limit of normal), and lvef (left ventricular ejection fraction by institutional criteria); bilirubin within 1.5 times institutional upper limit of normal; creatinine within 1.5 times institutional upper limit of normal; and no serious disease other than breast cancer.

boolean

C1321605 (UMLS CUI [1])
C0023508 (UMLS CUI [2])
C0200633 (UMLS CUI [3])
C0005821 (UMLS CUI [4])
C0428772 (UMLS CUI [5])
C1278039 (UMLS CUI [6])
C0201976 (UMLS CUI [7])
C0009488 (UMLS CUI [8])

pregnant or breast feeding, Gender, contraceptive methods

Item

pregnant or nursing women may not participate. men are ineligible. women of childbearing potential must be planning to use effective contraception.

boolean

C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0079399 (UMLS CUI [3])
C0700589 (UMLS CUI [4])

informed consent

Item

all patients must be informed of the investigational nature of this study and give written informed consent in accordance with institution and federal guidelines.

boolean

C0021430 (UMLS CUI [1])

date of institutional review board approval must be provided to the statistical center

Item

at the time of registration, the date of institutional review board approval for this study must be provided to the statistical center.

boolean

C1321605 (UMLS CUI [1])

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Eligibility High Risk NCT00590785