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

NCT02830282 | Completed DMC

• 1 other identifier: UPCC 16113
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

Blood Collection OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Angela DeMichele, MD

  Abramson Cancer Center at Penn Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2016
• First Posted: July 12, 2016
• Study Start: July 1, 2013
• Primary Completion: March 16, 2018
• Study Completion: March 16, 2018
• Last Updated: February 24, 2020

Record last verified: 2020-02

Locations

US (1)