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Table 1 Study inclusion/exclusion criteria

From: Content validity of the National Comprehensive Cancer Network – Functional Assessment of Cancer Therapy – Breast Cancer Symptom Index (NFBSI-16) and Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form with advanced breast cancer patients

Inclusion criteria:

 • Subject had to sign and date a written Informed Consent Form (ICF);

 • Subject was an adult man or woman (≥18 years of age) at the time of screening;

 • Subject had clinician confirmation of metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy;

 • Subject had clinician confirmation of hormone-receptor positive (HR+; estrogen receptor positive and/or progesterone receptor positive) and human epidermal growth factor receptor-2 negative (HER2-) breast cancer;

 • Subject was able to speak, read, write, and comprehend US English fluently, as determined by clinician; and

 • Subject was willing and able to participate in a 90-min, face-to-face or telephone interview.

Exclusion criteria:

 • Subject had received more than three lines of therapy for advanced breast cancer;

 • Subject had central nervous system involvement such as brain metastases or spinal cord compression;

 • Subject had participated in an interventional clinical trial in the past 30 days; or

 • Subject had any other concurrent severe and/or uncontrolled medical condition including a cognitive impairment or disorder that might confound study results and/or contraindicate subject’s participation in the study, in the opinion of the clinician.