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Trial record 3 of 3 for:    I-Spy2
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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
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center at Penn Medicine

Study Description
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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.

Condition or disease Intervention/treatment
Breast Cancer Other: Blood Collection

Study Design
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Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of disseminated tumor cells (DTCs), [ Time Frame: 2 years ]
  2. Number of circulating tumor cells (CTCs) [ Time Frame: 2 years ]
  3. Number of other circulating tumor biomarkers (CBMs) [ Time Frame: 2 years ]

Eligibility Criteria
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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
Study Population
women undergoing neoadjuvant chemotherapy for primary breast cancer who are undergoing definitive surgical resection and have clinical or radiographic evidence of residual tumor at the completion of chemotherapy
Criteria

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.
Contacts and Locations
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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


Locations
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United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center at Penn Medicine
Investigators
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Principal Investigator: Angela DeMichele, MD Abramson Cancer Center at Penn Medicine
More Information
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Responsible Party: Abramson Cancer Center at Penn Medicine
ClinicalTrials.gov Identifier: NCT02830282    
Other Study ID Numbers: UPCC 16113
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 2020
Additional relevant MeSH terms:
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Breast Neoplasms
Recurrence
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Disease Attributes
Pathologic Processes