BREAST CANCER METASTATIC RECURRENT HER2 Positive | Secondary malignant neoplasm of female breast HER2 Positive Refractory | Locally advanced breast cancer HER2 Positive Relapsed | Locally advanced breast cancer HER2 Positive Refractory | Estrogen receptor positive tumor | Progesterone receptor positive tumor | Estrogen receptor negative neoplasm | Progesterone receptor negative neoplasm
Item
histologically-proven metastatic or locally-advanced relapsed/refractory her2+ breast cancer. tumors may be estrogen receptor (er)/progesterone receptor (pr) positive or negative.
boolean
C0741681 (UMLS CUI [1,1])
C2348909 (UMLS CUI [1,2])
C0346993 (UMLS CUI [2,1])
C2348909 (UMLS CUI [2,2])
C0205269 (UMLS CUI [2,3])
C3495949 (UMLS CUI [3,1])
C2348909 (UMLS CUI [3,2])
C0205336 (UMLS CUI [3,3])
C3495949 (UMLS CUI [4,1])
C2348909 (UMLS CUI [4,2])
C0205269 (UMLS CUI [4,3])
C1562312 (UMLS CUI [5])
C1562928 (UMLS CUI [6])
C2584629 (UMLS CUI [7])
C2584628 (UMLS CUI [8])
pertuzumab | trastuzumab | ado-trastuzumab emtansine | Neoadjuvant Setting | Adjuvant Setting | Metastatic Setting | Prior radiation therapy | Prior Hormone Therapy
Item
prior treatment with pertuzumab, trastuzumab, and ado-trastuzumab emtansine in the neoadjuvant, adjuvant, or metastatic setting. prior radiotherapy and hormonal therapies are allowed.
boolean
C1328025 (UMLS CUI [1])
C0728747 (UMLS CUI [2])
C2935436 (UMLS CUI [3])
C4086621 (UMLS CUI [4])
C4084850 (UMLS CUI [5])
C4085632 (UMLS CUI [6])
C0279134 (UMLS CUI [7])
C1514460 (UMLS CUI [8])
Prior Therapy Quantity Metastatic Setting | Disease Progression
Item
prior treatment for at least one, and no more than two, lines of therapy in the metastatic setting. patients must have progressed on or following, the most recent line of therapy.
boolean
C1514463 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C4085632 (UMLS CUI [1,3])
C0242656 (UMLS CUI [2])
Toxicity Due to Chemotherapy | Toxicity due to radiotherapy | Resolution CTCAE Grades
Item
resolution of all chemotherapy or radiation-related toxicities to ≤ grade 1
boolean
C0600688 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0392920 (UMLS CUI [1,3])
C1302210 (UMLS CUI [2])
C1514893 (UMLS CUI [3,1])
C1516728 (UMLS CUI [3,2])
Life Expectancy
Item
life expectancy ≥ 12 weeks
boolean
C0023671 (UMLS CUI [1])
Laboratory Results Acceptable
Item
acceptable laboratory parameters
boolean
C1254595 (UMLS CUI [1,1])
C1879533 (UMLS CUI [1,2])
Childbearing Potential Pregnancy test negative | Childbearing Potential Contraceptive methods
Item
women of childbearing potential must have negative pregnancy test, and agree to use an effective form of contraception for the duration of study treatment and for 120 days after the last dose of study drug
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Metastatic malignant neoplasm to brain Untreated
Item
known, untreated brain metastasis
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
Seizures Uncontrolled
Item
history of uncontrolled seizures
boolean
C0036572 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Allogeneic bone marrow transplantation | Allogeneic Stem Cell Transplantation | Solid organ transplant Allogeneic
Item
prior allogeneic bone marrow, stem-cell, or solid organ transplantation
boolean
C0149615 (UMLS CUI [1])
C2242529 (UMLS CUI [2])
C0730400 (UMLS CUI [3,1])
C1515895 (UMLS CUI [3,2])
Cardiovascular Disease
Item
history of clinically significant cardiovascular disease
boolean
C0007222 (UMLS CUI [1])
Pulmonary function impairment | Requirement Supplemental oxygen
Item
clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use
boolean
C0858943 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C4534306 (UMLS CUI [2,2])
Medical contraindication Trastuzumab | Condition Preventing Chemotherapy
Item
any condition that would be a contraindication to receiving trastuzumab as described in the approved local label or a condition that would prevent treatment with the protocol specified chemotherapies
boolean
C1301624 (UMLS CUI [1,1])
C0728747 (UMLS CUI [1,2])
C0348080 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0392920 (UMLS CUI [2,3])