Gender
Item
1. female;
boolean
C0079399 (UMLS CUI [1])
Invasive carcinoma of breast Examination of breast | Invasive carcinoma of breast Diagnostic Imaging | Invasive carcinoma of breast Biopsy tissue
Item
2. diagnosis of invasive breast cancer by clinical breast examination, by standard of care diagnostic imaging, or by initial tissue biopsy;
boolean
C0853879 (UMLS CUI [1,1])
C0199850 (UMLS CUI [1,2])
C0853879 (UMLS CUI [2,1])
C0011923 (UMLS CUI [2,2])
C0853879 (UMLS CUI [3,1])
C3864006 (UMLS CUI [3,2])
Systemic Chemotherapy Primary Neoadjuvant Planned | Excision Primary tumor Residual | Status post Chemotherapy Neoadjuvant Completion
Item
3. planned for primary systemic (neoadjuvant) chemotherapy and surgical resection of residual primary tumor following completion of neoadjuvant chemotherapy;
boolean
C1883256 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1298676 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
C0728940 (UMLS CUI [2,1])
C0677930 (UMLS CUI [2,2])
C1609982 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0392920 (UMLS CUI [3,2])
C1298676 (UMLS CUI [3,3])
C0205197 (UMLS CUI [3,4])
Tumor size Imaging | Tumor size Physical Examination
Item
4. tumor size ≥ 2cm, measured on imaging or estimated by physical exam;
boolean
C0475440 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C0475440 (UMLS CUI [2,1])
C0031809 (UMLS CUI [2,2])
Operation on breast Planned | Mastectomy | Segmental Mastectomy | Breast-Conserving Surgery | Status post Neoadjuvant Therapy Completion
Item
5. planned definitive breast surgery (mastectomy or lumpectomy/breast conservation) following completion of neoadjuvant therapy;
boolean
C3714726 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0024881 (UMLS CUI [2])
C0024885 (UMLS CUI [3])
C0917927 (UMLS CUI [4])
C0231290 (UMLS CUI [5,1])
C0600558 (UMLS CUI [5,2])
C0205197 (UMLS CUI [5,3])
Age
Item
6. age 18 years or older;
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Karnofsky Performance Status
Item
7. eastern cooperative oncology group (ecog) performance status ≤ 2 (karnofsky performance status ≥ 60%;
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Organ function | Bone Marrow function
Item
8. adequate organ and marrow function, as defined at boston medical center;
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
Postmenopausal state | Female Sterilization | Pregnancy Absent | Pregnancy test negative | Contraceptive methods Willing | Hormonal contraception | Contraception, Barrier
Item
9. postmenopausal for a minimum of one year, or surgically sterile, or not pregnant, confirmed by a pregnancy test as per institutional standard of care, and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation;
boolean
C0232970 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0032961 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0427780 (UMLS CUI [4])
C0700589 (UMLS CUI [5,1])
C0600109 (UMLS CUI [5,2])
C2985296 (UMLS CUI [6])
C0004764 (UMLS CUI [7])
Informed Consent
Item
10. able to understand and willing to sign a written informed consent document and a health insurance portability and accountability act (hipaa) authorization in accordance with institutional guidelines.
boolean
C0021430 (UMLS CUI [1])
Prior Therapy Breast Involved | Chemotherapy Breast Involved | Therapeutic radiology procedure Breast Involved | Operative Surgical Procedures Breast Involved
Item
1. previous treatment (chemotherapy, radiation, or surgery) to involved breast;
boolean
C1514463 (UMLS CUI [1,1])
C0006141 (UMLS CUI [1,2])
C1314939 (UMLS CUI [1,3])
C0392920 (UMLS CUI [2,1])
C0006141 (UMLS CUI [2,2])
C1314939 (UMLS CUI [2,3])
C1522449 (UMLS CUI [3,1])
C0006141 (UMLS CUI [3,2])
C1314939 (UMLS CUI [3,3])
C0543467 (UMLS CUI [4,1])
C0006141 (UMLS CUI [4,2])
C1314939 (UMLS CUI [4,3])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
2. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements;
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Unstable status Medical
Item
3. medically unstable;
boolean
C0443343 (UMLS CUI [1,1])
C0205476 (UMLS CUI [1,2])
Age
Item
4. under age 18;
boolean
C0001779 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
5. pregnant or nursing;
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Malignant Neoplasms Previous | Exception Basal cell carcinoma | Exception Squamous cell carcinoma of skin | Exception Carcinoma in situ of uterine cervix | Exception Disease Free Duration
Item
6. previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which the patient has been disease free for less than 5 years;
boolean
C0006826 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0553723 (UMLS CUI [3,2])
C1705847 (UMLS CUI [4,1])
C0851140 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0012634 (UMLS CUI [5,2])
C0332296 (UMLS CUI [5,3])
C0449238 (UMLS CUI [5,4])
Medical contraindication Chemotherapy Primary
Item
7. no contraindications for primary chemotherapy.
boolean
C1301624 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C0205225 (UMLS CUI [1,3])