Ductal carcinoma in situ | Invasive carcinoma of breast
Item
1. women with a biopsy proven diagnosis of ductal carcinoma in situ or invasive carcinoma of the breast
boolean
C0007124 (UMLS CUI [1])
C0853879 (UMLS CUI [2])
Biopsy tissue Slide | Biopsy tissue Block | Diagnosis Confirmation
Item
a. biopsy tissue (either slides or block) from outside institutions will be reviewed to confirm diagnosis.
boolean
C0521093 (UMLS CUI [1,1])
C3864006 (UMLS CUI [1,2])
C1705201 (UMLS CUI [1,3])
C3864006 (UMLS CUI [2,1])
C1533157 (UMLS CUI [2,2])
C0011900 (UMLS CUI [3,1])
C0750484 (UMLS CUI [3,2])
Patients Appropriate Breast Preservation | Radiotherapy to breast Absent | Radiotherapy to lymph nodes Absent | Absence Disease Multicentric Imaging | Absence Disease Multifocal Imaging | Pregnancy Absent | Absence Comorbidity Preventing Operative Surgical Procedures
Item
2. breast preservation candidates (no prior breast or nodal radiotherapy, no imaging evidence of multicentric or multifocal disease, no pregnant women, and no comorbid conditions precluding surgery)
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0006141 (UMLS CUI [1,3])
C1514402 (UMLS CUI [1,4])
C0948310 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C1504399 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0332197 (UMLS CUI [4,1])
C0012634 (UMLS CUI [4,2])
C0439743 (UMLS CUI [4,3])
C0011923 (UMLS CUI [4,4])
C0332197 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0205292 (UMLS CUI [5,3])
C0011923 (UMLS CUI [5,4])
C0032961 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0332197 (UMLS CUI [7,1])
C0009488 (UMLS CUI [7,2])
C1292733 (UMLS CUI [7,3])
C0543467 (UMLS CUI [7,4])
Invasive carcinoma of breast TNM Breast tumor staging | DCIS Size
Item
3. clinical t1n0m0 invasive carcinoma or ductal carcinoma in situ (dcis) < or equal to 2cm
boolean
C0853879 (UMLS CUI [1,1])
C0474926 (UMLS CUI [1,2])
C0007124 (UMLS CUI [2,1])
C0456389 (UMLS CUI [2,2])
Age | Oncotype test Score low
Item
4. 60 years of age or older or 50-59 with a low oncotype score (0-17)
boolean
C0001779 (UMLS CUI [1])
C4523849 (UMLS CUI [2,1])
C0449820 (UMLS CUI [2,2])
C0205251 (UMLS CUI [2,3])
Estrogen receptor positive | HER2 Negative
Item
5. estrogen receptor positive (er+), human epidermal growth factor 2 negative (her2-)
boolean
C0279754 (UMLS CUI [1])
C2348908 (UMLS CUI [2])
Childbearing Potential Contraceptive methods | Female Sterilization | Tubal Ligation | Hysterectomy | Contraceptives, Oral, Hormonal | Contraceptives, Oral | Contraceptive patch | Contraceptive implant | Contraceptive injection | Contraception, Barrier | Female Condoms | Vaginal contraceptive diaphragm | Vaginal Spermicides | Intrauterine Devices | Plan B Unacceptable
Item
6. women of child-bearing potential must consent to use adequate contraception during the course of the study. female subjects must agree to use a medically acceptable contraceptives including: (1) surgical sterilization (such as a tubal ligation or hysterectomy), (2) approved hormonal contraceptives (such as birth control pills, patches, implants or injections), (3) barrier methods (such as a condom or diaphragm) used with a spermicide, or (4) an intrauterine device (iud). contraceptive measures such as plan b (tm), sold for emergency use after unprotected sex, are not acceptable methods for routine use.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0015787 (UMLS CUI [2])
C0520483 (UMLS CUI [3])
C0020699 (UMLS CUI [4])
C0009907 (UMLS CUI [5])
C0009905 (UMLS CUI [6])
C2985284 (UMLS CUI [7])
C1657106 (UMLS CUI [8])
C1656586 (UMLS CUI [9])
C0004764 (UMLS CUI [10])
C0221829 (UMLS CUI [11])
C0042241 (UMLS CUI [12])
C0087145 (UMLS CUI [13])
C0021900 (UMLS CUI [14])
C0876128 (UMLS CUI [15,1])
C1883420 (UMLS CUI [15,2])
White Blood Cell Count procedure | Hemoglobin measurement | Platelet Count measurement
Item
7. white blood cells (wbc) > 3000, hemoglobin ( hgb) > 9, platelets >100000 within 30 days of consent
boolean
C0023508 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
C0032181 (UMLS CUI [3])
Eligibility MRI with contrast | Glomerular Filtration Rate | MRI
Item
8. eligible for contrasted magnetic resonance imaging (mri) on initial evaluation with glomerular filtration rate (gfr) ≥ 60 ml/min. a diagnostic mri ordered within one month will be considered an acceptable alternative and will not be repeated.
boolean
C1548635 (UMLS CUI [1,1])
C0202671 (UMLS CUI [1,2])
C0017654 (UMLS CUI [2])
C0024485 (UMLS CUI [3])
Breast Imaging Consistent with Clinical Trial Eligibility Criteria
Item
9. outside breast imaging will be reviewed at duke to confirm findings are consistent with trial eligibility.
boolean
C0006141 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0332290 (UMLS CUI [1,3])
C1516637 (UMLS CUI [1,4])
Chemotherapy Neoadjuvant
Item
1. neoadjuvant chemotherapy
boolean
C0392920 (UMLS CUI [1,1])
C1298676 (UMLS CUI [1,2])
Breast implant | Breast Planned Stereotactic Body Radiation Therapy
Item
2. breast implant in the breast to be treated with sbrt
boolean
C0179412 (UMLS CUI [1])
C0006141 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C3896609 (UMLS CUI [2,3])
Medical condition At risk Unsatisfactory outcome of cosmetic surgery | Lupus Erythematosus | Rheumatoid Arthritis | Scleroderma
Item
3. medical conditions that may increase risk for poor cosmetic outcome (i.e. lupus, rheumatoid arthritis, scleroderma)
boolean
C3843040 (UMLS CUI [1,1])
C1444641 (UMLS CUI [1,2])
C4546170 (UMLS CUI [1,3])
C0409974 (UMLS CUI [2])
C0003873 (UMLS CUI [3])
C0011644 (UMLS CUI [4])
Investigational Therapy Receive Unable | Lacking Able to lie down Prone Position
Item
4. subjects unable to receive study treatment planning secondary to body habitus or inability to lie flat on the stomach at length
boolean
C0949266 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C0560841 (UMLS CUI [2,2])
C0033422 (UMLS CUI [2,3])
HER2 Positive
Item
5. her2 positive
boolean
C2348909 (UMLS CUI [1])
Serum pregnancy test positive
Item
6. positive serum pregnancy test
boolean
C0430063 (UMLS CUI [1])
Breast Imaging Insufficient | TNM Breast tumor staging Unsuccessful
Item
7. insufficient breast imaging to judge clinical stage
boolean
C0006141 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
C0474926 (UMLS CUI [2,1])
C1272705 (UMLS CUI [2,2])
Biopsy Clip placement Unwilling
Item
8. subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement.
boolean
C0005558 (UMLS CUI [1,1])
C4489472 (UMLS CUI [1,2])
C0558080 (UMLS CUI [1,3])
Treatment Constraints Fulfill Unsuccessful
Item
9. subjects in whom treatment planning constraints cannot be met
boolean
C0087111 (UMLS CUI [1,1])
C0443288 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C1272705 (UMLS CUI [1,4])