Role of the Immune Environment in Response to Therapy in Breast Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorAbramson Cancer Center at Penn Medicine

About this trial

This is an observational case-control study of tissues collected from women with ER+HER2- breast cancers. The immune environments of these cancers will be compared to triple negative and HER2+ breast cancers. No randomization or changes to standard of care treatment will occur as part of the study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Women 18 years of age or older undergoing surgery for breast cancer.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.

    Other intervention

    Collection of personal health information from women treated at the University of Pennsylvania under an approved HIPAA waiver.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Collecting, processing and archiving breast cancer tumor tissues

This study will collect and analyze tumor samples from women diagnosed with primary breast cancer. The investigators will dissociate fresh tumor samples and analyze single cell suspensions by flow cytometry. Percentage of dendritic cell and T cell subsets and dendritic cell and T cell activation markers will be compared between breast cancer subtypes (HR+HER2-, HER2+, triple negative). Percentage of dendritic cell and T cell subsets and dendritic cell and T cell activation markers will be compared between HR+HER2- untreated breast cancers compared to HR+HER2- chemotherapy treated breast cancers.

Time frame
Through study completion, average of 2 years

Secondary outcomes

1

Associating breast cancer dendritic cell infiltrate with outcome

We will perform studies to associate dendritic cell infiltration and activation markers with patient outcome, including disease free survival, distant disease free survival, and overall survival.

Time frame
5 years

Other outcomes

Sponsors and contacts

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