ID

12121

Description

Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women; ODM derived from: https://clinicaltrials.gov/show/NCT02400567

Link

https://clinicaltrials.gov/show/NCT02400567

Keywords

Versions (1)
  1. 9/25/15 9/25/15 - Julian Varghese
Uploaded on

September 25, 2015

DOI

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License

Creative Commons BY 4.0
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Eligibility Neoadjuvant Operable Breast Cancer NCT02400567

English

Eligibility Neoadjuvant Operable Breast Cancer NCT02400567

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. aged 18 years, post-menopausal women
Description

Age | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0232970
2. newly diagnosed and operable unilateral invasive breast cancer, not candidate or uncertain for breast conservation - note: multicentric/multifocal tumors are allowed provided a maximum of 3 lesions are present, and all share the same characteristics: er allred 4, her2- (pam50 will be performed in the largest lesion)
Description

Breast cancer invasive NOS; Unilateral; Breast-Conserving Surgery; Eligibility Determination

Data type

boolean

Alias
UMLS CUI [1,1]
C0853879
UMLS CUI [1,2]
C0205092
UMLS CUI [1,3]
C0917927
UMLS CUI [1,4]
C0013893
3. stage ii-iiia
Description

stage ii-iiia

Data type

boolean

Alias
UMLS CUI [1]
C2216702
4. assessment of nodal status available (ultrasound guided fna or biopsy if necessary)
Description

ultrasound; assessment; available; biopsy; status

Data type

boolean

Alias
UMLS CUI [1]
C0449927
5. non metastatic, m0
Description

metastatic; non

Data type

boolean

Alias
UMLS CUI [1]
C0445034
6. er-positive by ihc (allred score≥4)
Description

allred score; positive

Data type

boolean

Alias
UMLS CUI [1]
C2919519
7. her2-negative by ihc (score 0 or 1+) and/or fish/cish
Description

negative; score; cish

Data type

boolean

Alias
UMLS CUI [1]
CL412283
UMLS CUI [2]
C0449820
UMLS CUI [3]
C0299250
8. either luminal a and proven nodal involvement (cytology or histology), or luminal b through pam50 ror (prosigna™) centralized evaluation
Description

luminal type; TNM pathologic staging - nodal involvement - N

Data type

boolean

Alias
UMLS CUI [1]
C3642345
UMLS CUI [2]
C3642346
UMLS CUI [3]
C3258251
9. ecog 0-1
Description

ecog

Data type

boolean

Alias
UMLS CUI [1]
C1520224
10. no prior systemic therapy for the present tumor
Description

prior systemic therapy; present; tumor

Data type

boolean

Alias
UMLS CUI [1]
C1515119
11. adequate renal, hepatic, and hematopoietic functions as defined by the following criteria: absolute neutrophil count (anc) ≥1,500/mm3 or ≥1.5 x 109/l
Description

absolute neutrophil count (anc) >=1,500/mm^3; absolute neutrophil count (anc) >=1500/mm3

Data type

boolean

Alias
UMLS CUI [1]
C0200633
platelets ≥100,000/mm3 or ≥100 x 109/l
Description

platelets

Data type

boolean

Alias
UMLS CUI [1]
C1287267
hemoglobin ≥9 g/dl
Description

hemoglobin

Data type

boolean

Alias
UMLS CUI [1]
C0019046
serum aspartate transaminase (ast) and serum alanine aminotransferase transaminase (alt) ≤2.5 x upper limit of normal (uln)
Description

sgot sgpt got gpt

Data type

boolean

Alias
UMLS CUI [1]
C0242192
UMLS CUI [2]
C0376147
alkaline phosphatase ≤2.5 x uln
Description

alkaline phosphatase

Data type

boolean

Alias
UMLS CUI [1]
C0201850
total serum bilirubin ≤1 x uln
Description

bilirubin; serum; uln

Data type

boolean

Alias
UMLS CUI [1]
C1278039
serum creatinine ≤1.5 x uln or estimated creatinine clearance ≥ 60 ml/min as calculated using the method standard for the institution
Description

estimated creatinine clearance; serum creatinine; institution; method; uln

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0373595
12 adequate cardiac functions, including: lead electrocardiogram (ecg) with normal tracing or non clinically significant changes that do not require medical intervention.
Description

clinically significant; electrocardiogram; normal; ecg; non

Data type

boolean

Alias
UMLS CUI [1]
C0522054
qtc interval ≤480 msec
Description

qtc interval

Data type

boolean

Alias
UMLS CUI [1]
C0489625
no history of torsades de pointes or other symptomatic qtc abnormality.
Description

symptomatic; other

Data type

boolean

Alias
UMLS CUI [1]
C0040479
UMLS CUI [2,1]
C0489625
UMLS CUI [2,2]
C0205161
13. willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
Description

compliance

Data type

boolean

Alias
UMLS CUI [1]
C1321605
14. signed informed consent and health insurance coverage
Description

signed informed consent; health insurance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0021682
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. non operable, bilateral, t4 or metastatic breast cancer
Description

metastatic; bilateral; breast; cancer; non

Data type

boolean

Alias
UMLS CUI [1,1]
C0006142
UMLS CUI [1,2]
C0238767
UMLS CUI [2,1]
C0006142
UMLS CUI [2,2]
C0205187
UMLS CUI [3]
C0278488
UMLS CUI [4]
C2216713
2. limited t2 breast cancer immediately accessible to conservative surgery
Description

surgery; breast; cancer

Data type

boolean

Alias
UMLS CUI [1]
C0038894
UMLS CUI [2]
C0006141
UMLS CUI [3]
C0006826
UMLS CUI [4,1]
C0917927
UMLS CUI [4,2]
C0013893
3. previous homolateral breast cancer (including in situ carcinoma), and/or contralateral breast cancer except if treated by surgery +/- radiation therapy alone without any systemic treatment
Description

contralateral breast cancer; radiation therapy; treated by; treatment; systemic; surgery

Data type

boolean

Alias
UMLS CUI [1]
C0006142
UMLS CUI [2]
C1515119
UMLS CUI [3]
C1522449
4. previous hormone replacement therapy (hrt) stopped less than 2 weeks before beginning of treatment
Description

hormone replacement therapy; treatment

Data type

boolean

Alias
UMLS CUI [1]
C0282402
5. previous use of serms such as raloxifene
Description

raloxifene

Data type

boolean

Alias
UMLS CUI [1]
C0244404
6. any surgery (not including minor procedures such as lymph node biopsy, primary tumor core biopsy, fine needle aspiration) within 4 weeks of start of study treatment; or not fully recovered from any side effects of previous procedures.
Description

major surgery | post operative state

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0241311
7. diagnosis of any previous malignancy within the last 5 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma
Description

diagnosis; malignancy; cervical; squamous; skin; last

Data type

boolean

Alias
UMLS CUI [1]
C0007137
UMLS CUI [2]
C0006826
UMLS CUI [3]
C0007117
UMLS CUI [4]
C0851140
8. history of any previous anti-cancer chemotherapy and any previous treatment using ai
Description

cancer chemotherapy; treatment

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C0593802
9. concurrent administration of herbal preparations as complementary medicine.
Description

herbal preparations as complementary medicine.

Data type

boolean

Alias
UMLS CUI [1]
C0025125
10. any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drugs, such as the inability to take oral medication in tablet form and malabsorption syndrome
Description

inability to take oral medications; clinically significant; gastrointestinal; malabsorption; abnormalities; syndrome; tablet; drugs; form; study

Data type

boolean

Alias
UMLS CUI [1]
C3714657
11. patient with any psychological, familial, social or geographical condition which could potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
Description

sociological psychological factors

Data type

boolean

Alias
UMLS CUI [1]
C1658764
UMLS CUI [2]
C0021430
UMLS CUI [3]
C3850138
UMLS CUI [4]
C1321605
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Similar models

Eligibility Neoadjuvant Operable Breast Cancer NCT02400567

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Postmenopausal state
Item
1. aged 18 years, post-menopausal women
boolean
C0001779 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Breast cancer invasive NOS; Unilateral; Breast-Conserving Surgery; Eligibility Determination
Item
2. newly diagnosed and operable unilateral invasive breast cancer, not candidate or uncertain for breast conservation - note: multicentric/multifocal tumors are allowed provided a maximum of 3 lesions are present, and all share the same characteristics: er allred 4, her2- (pam50 will be performed in the largest lesion)
boolean
C0853879 (UMLS CUI [1,1])
C0205092 (UMLS CUI [1,2])
C0917927 (UMLS CUI [1,3])
C0013893 (UMLS CUI [1,4])
stage ii-iiia
Item
3. stage ii-iiia
boolean
C2216702 (UMLS CUI [1])
ultrasound; assessment; available; biopsy; status
Item
4. assessment of nodal status available (ultrasound guided fna or biopsy if necessary)
boolean
C0449927 (UMLS CUI [1])
metastatic; non
Item
5. non metastatic, m0
boolean
C0445034 (UMLS CUI [1])
allred score; positive
Item
6. er-positive by ihc (allred score≥4)
boolean
C2919519 (UMLS CUI [1])
negative; score; cish
Item
7. her2-negative by ihc (score 0 or 1+) and/or fish/cish
boolean
CL412283 (UMLS CUI [1])
C0449820 (UMLS CUI [2])
C0299250 (UMLS CUI [3])
luminal type; TNM pathologic staging - nodal involvement - N
Item
8. either luminal a and proven nodal involvement (cytology or histology), or luminal b through pam50 ror (prosigna™) centralized evaluation
boolean
C3642345 (UMLS CUI [1])
C3642346 (UMLS CUI [2])
C3258251 (UMLS CUI [3])
ecog
Item
9. ecog 0-1
boolean
C1520224 (UMLS CUI [1])
prior systemic therapy; present; tumor
Item
10. no prior systemic therapy for the present tumor
boolean
C1515119 (UMLS CUI [1])
absolute neutrophil count (anc) >=1,500/mm^3; absolute neutrophil count (anc) >=1500/mm3
Item
11. adequate renal, hepatic, and hematopoietic functions as defined by the following criteria: absolute neutrophil count (anc) ≥1,500/mm3 or ≥1.5 x 109/l
boolean
C0200633 (UMLS CUI [1])
platelets
Item
platelets ≥100,000/mm3 or ≥100 x 109/l
boolean
C1287267 (UMLS CUI [1])
hemoglobin
Item
hemoglobin ≥9 g/dl
boolean
C0019046 (UMLS CUI [1])
sgot sgpt got gpt
Item
serum aspartate transaminase (ast) and serum alanine aminotransferase transaminase (alt) ≤2.5 x upper limit of normal (uln)
boolean
C0242192 (UMLS CUI [1])
C0376147 (UMLS CUI [2])
alkaline phosphatase
Item
alkaline phosphatase ≤2.5 x uln
boolean
C0201850 (UMLS CUI [1])
bilirubin; serum; uln
Item
total serum bilirubin ≤1 x uln
boolean
C1278039 (UMLS CUI [1])
estimated creatinine clearance; serum creatinine; institution; method; uln
Item
serum creatinine ≤1.5 x uln or estimated creatinine clearance ≥ 60 ml/min as calculated using the method standard for the institution
boolean
C0201976 (UMLS CUI [1])
C0373595 (UMLS CUI [2])
clinically significant; electrocardiogram; normal; ecg; non
Item
12 adequate cardiac functions, including: lead electrocardiogram (ecg) with normal tracing or non clinically significant changes that do not require medical intervention.
boolean
C0522054 (UMLS CUI [1])
qtc interval
Item
qtc interval ≤480 msec
boolean
C0489625 (UMLS CUI [1])
symptomatic; other
Item
no history of torsades de pointes or other symptomatic qtc abnormality.
boolean
C0040479 (UMLS CUI [1])
C0489625 (UMLS CUI [2,1])
C0205161 (UMLS CUI [2,2])
compliance
Item
13. willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
boolean
C1321605 (UMLS CUI [1])
signed informed consent; health insurance
Item
14. signed informed consent and health insurance coverage
boolean
C0021430 (UMLS CUI [1])
C0021682 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
metastatic; bilateral; breast; cancer; non
Item
1. non operable, bilateral, t4 or metastatic breast cancer
boolean
C0006142 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
C0006142 (UMLS CUI [2,1])
C0205187 (UMLS CUI [2,2])
C0278488 (UMLS CUI [3])
C2216713 (UMLS CUI [4])
surgery; breast; cancer
Item
2. limited t2 breast cancer immediately accessible to conservative surgery
boolean
C0038894 (UMLS CUI [1])
C0006141 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
C0917927 (UMLS CUI [4,1])
C0013893 (UMLS CUI [4,2])
contralateral breast cancer; radiation therapy; treated by; treatment; systemic; surgery
Item
3. previous homolateral breast cancer (including in situ carcinoma), and/or contralateral breast cancer except if treated by surgery +/- radiation therapy alone without any systemic treatment
boolean
C0006142 (UMLS CUI [1])
C1515119 (UMLS CUI [2])
C1522449 (UMLS CUI [3])
hormone replacement therapy; treatment
Item
4. previous hormone replacement therapy (hrt) stopped less than 2 weeks before beginning of treatment
boolean
C0282402 (UMLS CUI [1])
raloxifene
Item
5. previous use of serms such as raloxifene
boolean
C0244404 (UMLS CUI [1])
major surgery | post operative state
Item
6. any surgery (not including minor procedures such as lymph node biopsy, primary tumor core biopsy, fine needle aspiration) within 4 weeks of start of study treatment; or not fully recovered from any side effects of previous procedures.
boolean
C0679637 (UMLS CUI [1])
C0241311 (UMLS CUI [2])
diagnosis; malignancy; cervical; squamous; skin; last
Item
7. diagnosis of any previous malignancy within the last 5 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma
boolean
C0007137 (UMLS CUI [1])
C0006826 (UMLS CUI [2])
C0007117 (UMLS CUI [3])
C0851140 (UMLS CUI [4])
cancer chemotherapy; treatment
Item
8. history of any previous anti-cancer chemotherapy and any previous treatment using ai
boolean
C0392920 (UMLS CUI [1])
C0593802 (UMLS CUI [2])
herbal preparations as complementary medicine.
Item
9. concurrent administration of herbal preparations as complementary medicine.
boolean
C0025125 (UMLS CUI [1])
inability to take oral medications; clinically significant; gastrointestinal; malabsorption; abnormalities; syndrome; tablet; drugs; form; study
Item
10. any clinically significant gastrointestinal abnormalities, which may impair intake, transit or absorption of the study drugs, such as the inability to take oral medication in tablet form and malabsorption syndrome
boolean
C3714657 (UMLS CUI [1])
sociological psychological factors
Item
11. patient with any psychological, familial, social or geographical condition which could potentially hamper compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
boolean
C1658764 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
C3850138 (UMLS CUI [3])
C1321605 (UMLS CUI [4])
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