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

NCT ID: NCT05396612

Last Updated: 2025-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-03

Study Completion Date

2032-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer ER Positive Breast Cancer HER2-negative Breast Cancer TNBC - Triple-Negative Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Women 18 years of age or older with non-metastatic breast cancer undergoing surgical resection in the University of Pennsylvania Health System.

Exclusion Criteria

Males Children Pregnant individuals
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Abramson Cancer Center at Penn Medicine

OTHER

Sponsor Role lead

Responsible Party

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Jennifer Zhang

Assistant Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jennifer Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Abramson Cancer Center

Locations

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Abramson Cancer Center

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Julia T. Lewandowski

Role: CONTACT

215-662-2861

Jennifer Zhang, MD

Role: CONTACT

215-615-6810

Other Identifiers

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850338

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 19121

Identifier Type: -

Identifier Source: org_study_id

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