ID

13623

Description

Phase III Comparison of Adjuvant Chemotherapy W/High-Dose Cyclophosphamide Plus Doxorubicin (AC) vs Sequential Doxorubicin Fol by Cyclophosphamide (A-C) in High Risk Breast Cancer Patients With 0-3 Positive Nodes (Intergroup, CALGB 9394); ODM derived from: https://clinicaltrials.gov/show/NCT00590785

Link

https://clinicaltrials.gov/show/NCT00590785

Keywords

Versions (1)
  1. 2/21/16 2/21/16 -
Uploaded on

February 21, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility High Risk NCT00590785

English

Eligibility High Risk NCT00590785

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility High Risk NCT00590785
Criteria
Description

Criteria

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.
Description

axillary dissection, lymph nodes

Data type

boolean

Alias
UMLS CUI [1]
C0193867
UMLS CUI [2]
C0024204
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:
Description

high-risk, chemotherapy indicated

Data type

boolean

Alias
UMLS CUI [1]
C0684030
UMLS CUI [2]
C0392920
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.
Description

er and pgr negative, tumor size

Data type

boolean

Alias
UMLS CUI [1]
C2919271
UMLS CUI [2]
C2919590
UMLS CUI [3]
C0475440
2. tumor that is greater than 2.0 cm in greatest diameter irrespective of hormone receptor status (including unknown).
Description

tumor size

Data type

boolean

Alias
UMLS CUI [1]
C0475440
3. tumor involves one to three axillary lymph nodes.
Description

Lymph node involvment

Data type

boolean

Alias
UMLS CUI [1]
C0392920
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).
Description

tumor stage

Data type

boolean

Alias
UMLS CUI [1]
C1300072
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.
Description

no evidence of breast cancer, criteria for bilateral breast cancer

Data type

boolean

Alias
UMLS CUI [1,1]
C0678222
UMLS CUI [1,2]
C0687702
UMLS CUI [2]
C0281267
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C0011008
UMLS CUI [2]
C0024881
UMLS CUI [3]
C0193867
UMLS CUI [4]
C0917927
UMLS CUI [5]
C0392920
UMLS CUI [6]
C1514463
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.
Description

prior radiotherapy

Data type

boolean

Alias
UMLS CUI [1]
C1522449
UMLS CUI [2]
C0419095
UMLS CUI [3]
C0006098
UMLS CUI [4]
C0917927
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.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1321605
UMLS CUI [2]
C0023508
UMLS CUI [3]
C0200633
UMLS CUI [4]
C0005821
UMLS CUI [5]
C0428772
UMLS CUI [6]
C1278039
UMLS CUI [7]
C0201976
UMLS CUI [8]
C0009488
pregnant or nursing women may not participate. men are ineligible. women of childbearing potential must be planning to use effective contraception.
Description

pregnant or breast feeding, Gender, contraceptive methods

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0079399
UMLS CUI [4]
C0700589
all patients must be informed of the investigational nature of this study and give written informed consent in accordance with institution and federal guidelines.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
at the time of registration, the date of institutional review board approval for this study must be provided to the statistical center.
Description

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

Data type

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility High Risk NCT00590785

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility High Risk NCT00590785
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
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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