Breast Cancer Clinical Trial

A Pilot Study of a Micro-Organosphere Drug Screen Platform to Lead Care in Advanced Breast Cancer

Summary

The purpose of this study is to assess the feasibility of generating patient derived micro-organospheres (PDMO) from patients with advanced breast cancer to determine sensitivity to the most common forms of chemotherapy used in advanced breast cancer care.

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Full Description

The purpose of this study is to determine the feasibility of generating sufficient patient derived micro-organospheres (PDMO) from a biopsy of a patient's advanced breast cancer to determine sensitivity to the most common forms of chemotherapy used in advanced breast cancer care. While subjects are on study, they will first receive a standard of care clinical biopsy from which extra tissue is taken for research purposes. Following the biopsy, a PDMO will be generated and they will receive a chemotherapy regimen as determined by their treating physician. This study aims to enroll 15 patients. Of this 15 patient cohort we aim to enroll 5 patients with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2-) disease, 5 patients with ER+/HER2+ or ER-/HER2+ disease, and 5 patients with ER-/HER2- (TNBC) disease. There are risks to having biopsies and blood draws that may include moderate bleeding and pain at the biopsy site.

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Eligibility Criteria

Inclusion Criteria:

Provide written informed consent.
Female ages 18 or older.
Have measurable disease ≥ 2 cm defined by RECIST version 1.1.
Amenable to standard of care biopsy with co-consent to the Duke BioRepository & Precision Pathology Center (BRPC) protocol (Pro00035974) to collect extra biopsy tissue for research or willing to provide extra tissue other than standard of care without co-consent to BRPC.
Evidence of advanced cancer of the breast that is surgically unresectable with pathology confirming ER, PR, and HER2 status. NOTE: patients may enroll prior to receiving clinical biopsy results based on historical pathology results.

Patient is eligible for chemotherapy as monotherapy or in combination with single-agent anti HER2 Therapy.

ER+/PR+/HER2-, must have progressed or be intolerant to CDK 4/6 inhibitor and/or endocrine therapy unless CDK 4/6 inhibitor is not able to be provided per the clinician's discretion endocrine therapy and CDK 4/6 inhibitor
ER+/PR+/HER2+ or ER-/PR-HER2+, must have progressed or be intolerant to ≥ 2 lines of anti-HER2 therapy and be considered for mono-chemotherapy with trastuzumab and/or anti-HER2 tyrosine kinase inhibitor
ER-/PR-HER2-, PD-L1- and/or TMB <10 may may be considered for first line of treatment
Treating physician is planning to treat breast cancer in the advanced setting with a chemotherapy backbone. This study excludes patients who will receive an antibody-drug conjugate as their proposed treatment.
Impending visceral crisis is allowed only if the patient can have a biopsy prior to starting systemic mono-chemotherapy
ECOG performance status of 0, 1, or 2.
Any metastatic site that is ≥ 2cm and amenable to core needle biopsy. Patients with brain metastases are allowed and MOS may be generated from a resected breast cancer brain metastasis

Exclusion Criteria:

Actively requiring systemic antibiotics.
Clinically significant cardiac disease, including unstable angina or acute myocardial infarction within 6 months of enrollment.
Leptomeningeal disease
Pregnant women.
Enrolling on an investigational agent.

Study is for people with:

Breast Cancer

Estimated Enrollment:

7

Study ID:

NCT04655573

Recruitment Status:

Terminated

Sponsor:

Duke University

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There is 1 Location for this study

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Duke University Medical Center
Durham North Carolina, 27710, United States

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Study is for people with:

Breast Cancer

Estimated Enrollment:

7

Study ID:

NCT04655573

Recruitment Status:

Terminated

Sponsor:


Duke University

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