Surveillance Markers of Utility for Recurrence After Neoadjuvant Chemotherapy for Breast Cancer

Inclusion Criteria:

- Enrollment on the treatment phase of the I-SPY 2 TRIAL

- Completed a standard neoadjuvant chemotherapy regimen or assigned treatment on I-SPY 2
and planning definitive surgical resection. Participants who have discontinued
assigned treatment on I-SPY 2, switched to standard of care, and have completed a
standard neoadjuvant chemotherapy regimen are still considered eligible.

- Pre-surgical imaging or clinical examination demonstrating residual disease in the
breast. Participants with any extent of enhancement attributable to tumor on the
pre-surgical MRI are eligible. No minimum extent of palpable tumor pre-surgery is
required.

- Willing to undergo bone marrow aspiration and blood specimen collection per protocol
specifications

- No clinical evidence of distant metastatic disease. Pre-chemotherapy staging scans are
sufficient in the absence of any symptoms or subsequent clinical evidence suggesting
distant metastases

- Age 18 or over and are able to give informed consent

Exclusion Criteria:

- Individuals under the age of 18

- Individuals who cannot understand and give informed consent. We will not be assessing
decisional capacity; determination of ability to give informed consent will be at the
discretion of the treating physician.

- Pregnancy. Participants in the parent I-SPY 2 TRIAL are screened for pregnancy at
enrollment and pregnancy is an exclusion criteria. No additional screening for
pregnancy is required for participants enrolling on SURMOUNT. However if a study
participant does become pregnant while on study or during the course of the 10 year
follow-up, the study participant will remain on the study protocol and will not be
withdrawn. Because this is an observational study and does not have a therapeutic
component, there will be no increased risk to following a study participant through
annual blood draws and medical information abstraction from the medical chart who may
or may not become pregnant during the course of the follow-up period.