Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
1. Invasive breast cancer with radiographic and/or clinical evidence of advanced metastatic or unresectable disease
2. ER+/HER2- patients prior to starting 2nd line therapy or beyond
OR
ER/PR/HER2-negative (Triple Negative) patients prior to starting any line of therapy
Note: ER/PR/HER2 status is defined per the 2018 ASCO/CAP guidelines as follows:
ER-positive and PR-positive is defined as ≥1% reactive cells by immunohistochemical staining.
HER2 Negative Disease is defined by meeting one of the following criteria:
a) 0 or 1+ by IHC and not amplified by ISH
b) 0 or 1+ by IHC and ISH not done
c) 2+ by IHC and ISH results are: <6.0 HER2 signals/cell with HER2/CEP17 ratio <2.0
d) IHC not done and not amplified by ISH
3. Measurable and/or non-measurable disease is allowed
4. Male or female breast cancer is allowed
5. Age > 18 years
6. Willingness to provide mandatory blood specimens
7. Willing to return to enrolling institution for follow up imaging at least once
Exclusion Criteria:
1. Life expectancy of ≤ 6 months
2. Inability to provide blood samples based on the judgment of the treating physician
3. Weigh less than 110 pounds