Surveillance Markers of Utility for Recurrence After Neoadjuvant Chemotherapy for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02830282|
Recruitment Status : Completed
First Posted : July 12, 2016
Last Update Posted : February 24, 2020
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|Condition or disease||Intervention/treatment|
|Breast Cancer||Other: Blood Collection|
|Study Type :||Observational|
|Actual Enrollment :||21 participants|
|Official Title:||Surveillance Markers of Utility for Recurrence After Neoadjuvant Chemotherapy for Breast Cancer|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||March 16, 2018|
|Actual Study Completion Date :||March 16, 2018|
- Number of disseminated tumor cells (DTCs), [ Time Frame: 2 years ]
- Number of circulating tumor cells (CTCs) [ Time Frame: 2 years ]
- Number of other circulating tumor biomarkers (CBMs) [ Time Frame: 2 years ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830282
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Angela DeMichele, MD||Abramson Cancer Center of the University of Pennsylvania|
|Responsible Party:||Abramson Cancer Center of the University of Pennsylvania|
|Other Study ID Numbers:||
|First Posted:||July 12, 2016 Key Record Dates|
|Last Update Posted:||February 24, 2020|
|Last Verified:||February 2020|
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