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

NCT04655573 | Terminated DMC

• 1 other identifier: Pro00107118
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Breast Cancer

Keywords

Patient derived micro-organospheres (PDMO); Chemotherapy; Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with successful generation of PDMO from the patient's biopsy

  The PDMO establishment will be monitored and success will be defined as the formation of 3D organoid structures in at least 80% of droplets in each well, in 20 randomly sampled wells per PDMO model, within 7 days. With an anticipated generation of 90% we anticipate being able to generate 13 PDMO from the first 15 patients to perform a drug screen within 10 days of biopsy. The exact 90% lower confidence bound (LCB) will be computed for the proportion of patients with successful generation of PDMO and completed drug screen within 10 days. For the first 6 patients, if at least 5 PDMO can be generated and screened on 6 patients' samples the procedure will be deemed feasible. With 6 patients studied the exact 90% LCB assuming 5 successful cases is 0.71. We would thus be 90% confident that the success rate of this strategy is at least 71%.

  10 days of biopsy

Secondary Outcomes (1)

• Association between specific chemotherapy sensitivity in PDMO to clinical outcome of patient

  End of study (up to 2 years)

Study Arms (1)

Patient Derived Micro-Organospheres (PDMO)

Subjects will undergo image-guided biopsy as 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. PDMO are successfully generated, and the patient begins treatment with a hemotherapy backbone. A patient will be considered evaluable if pathology results are available from the biopsy.

Procedure: Breast Cancer Tumor Resection

Interventions

Breast Cancer Tumor Resection PROCEDURE

Patients with ABC will be receiving a biopsy, and a PDMO from the patient's biopsies will be generated from it. It is a model correlating clinical response with PDMO sensitivity to the most common forms of chemotherapy used in advanced breast cancer care.

Patient Derived Micro-Organospheres (PDMO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with advanced breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Patient derived tumor specimens that are cultured into patient-derived micro-organospheres (PDMO) for patients with ABC.

Study Officials

• Susan Dent

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2020
• First Posted: December 7, 2020
• Study Start: April 7, 2022
• Primary Completion: May 7, 2024
• Study Completion: May 7, 2024
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)