Breast Cancer Tumor Heterogeneity

NCT ID: NCT02108561

Last Updated: 2018-01-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 110 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-12-31

Brief Summary

Breast cancer biomarkers are usually performed on core needle biopsy (CNB) specimens and are not routinely repeated on surgical specimens (SS). However, preliminary data suggests that testing these biomarkers, on SS when compared to CNB samples can lead to different results. Our hypothesis is that The aim of this study is to identify a group of women with invasive breast cancer who may benefit from additional HER2 testing on their SS to ensure that areas of HER2 amplification are not missed. Another aim is to determine whether further HER2 testing on the SS in select patients would lead to changes in breast cancer treatment options.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Breast Cancer

Post Surgical Her2 testing

Post Surgical Her2 testing

Intervention Type: OTHER

Eligible patients will have post surgical Her2 testing on the primary tumor, a satellite lesion and a tumor positive node. The results will be provided to medical oncologist, who will comment as to whether the additional testing will prompt treatment recommendation changes

Interventions

Post Surgical Her2 testing

Eligible patients will have post surgical Her2 testing on the primary tumor, a satellite lesion and a tumor positive node. The results will be provided to medical oncologist, who will comment as to whether the additional testing will prompt treatment recommendation changes

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Women > age 18 with capacity to consent

2. Invasive breast cancer identified on CNB at AAMC within 45 days of study consent

3. IHC biomarkers performed on original CNB (including HER2)

4. Tumors with greater than 2cm of invasive disease (measured radiographically prior to resection or microscopically after resection), or

5. Multifocal or multicentric tumors

Exclusion Criteria

1. Men

2. Women with HER2 positive tumors detected on CNB specimens

3. Women receiving neoadjuvant chemotherapy

4. Women whose CNB or surgical resection was performed at a hospital other than AAMC. If the CNB prior to resection was repeated at AAMC and new tumor biomarkers were performed, then the patient is eligible for enrollment

5. Women whose IHC marker results were inconclusive on CNB or not performed -

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Anne Arundel Health System Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Anne Arundel Medical Center

Annapolis, Maryland, United States

Countries

United States

Other Identifiers

505185

Identifier Type: -

Identifier Source: org_study_id