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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02830282

Enrollment

Registered

2016-07-12

Start date

2013-07-31

Completion date

2018-03-16

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

This is a nested multicenter, prospective cohort study within the I-SPY 2 TRIAL for women undergoing neoadjuvant chemotherapy for primary breast cancer who are also undergoing definitive surgical resection and have clinical or radiographic evidence of residual tumor at the completion of chemotherapy.

Interventions

OTHERBlood Collection

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of disseminated tumor cells (DTCs),	2 years
Number of circulating tumor cells (CTCs)	2 years
Number of other circulating tumor biomarkers (CBMs)	2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026