Clinical trial · Observational
A Pilot Study of a Micro-Organosphere Drug Screen Platform to Lead Care in Advanced Breast Cancer
NCT04655573CI-TRIAL-00077217terminatedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): requested by sponsor
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Cancer Tumor Resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patient Derived Micro-Organospheres (PDMO)
- description
- 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.
- interventionNames
- Procedure: Breast Cancer Tumor Resection
Primary outcomes (1)
- measure
- The proportion of patients with successful generation of PDMO from the patient's biopsy
- timeFrame
- 10 days of biopsy
- description
- 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%.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Provide written informed consent. 2. Female ages 18 or older. 3. Have measurable disease ≥ 2 cm defined by RECIST version 1.1. 4. 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. 5. 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. 6. 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 7. 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. 8. Impending visceral crisis is allowed only if the patient can have a biopsy prior to starting systemic mono-chemotherapy 9. ECOG performance status of 0, 1, or 2. 10. 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: 1. Actively requiring systemic antibiotics. 2. Clinically significant cardiac disease, including unstable angina or acute myocardial infarction within 6 months of enrollment. 3. Leptomeningeal disease 4. Pregnant women. 5. Enrolling on an investigational agent.
References
Publications (0)
Data not yet available
No reference posted for this study.