Clinical trial · Observational
Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer
Development of Patient Derived Xenografts (PDX) in Patients With Breast Cancer Who Have Residual Disease After Neoadjuvant Systemic Therapy
NCT04703244CI-TRIAL-00104495recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Breast cancer patients who undergo neoadjuvant systemic therapy and have residual breast cancer identified at the time of surgery exhibit a high (\>50%) risk of future life-threatening recurrences and death.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Residual | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chemotherapy or endocrine therapy for breast cancer | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Generate patient derived xenografts (PDX) and organoids from breast cancer patients with residual disease after neoadjuvant therapy
- timeFrame
- Up to 12 months until death or a maximum of 20 years post registration
Secondary outcomes (7)
- measure
- Utilize patient derived xenografts (PDX) models to study new drugs/drug combinations
- timeFrame
- Up to 12 months until death or a maximum of 20 years post registration
- measure
- Utilize patient derived xenografts (PDX) models to identify mechanisms of treatment resistance
- timeFrame
- Up to 12 months until death or a maximum of 20 years post registration
- measure
- Correlate the association between Cell Free DNA (cfDNA), Circulating Tumor Cells (CTCs) and circulating immune cell subpopulations (as measured by CyTOF) with residual cancer burden
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years. * Diagnosis of invasive breast cancer treated with neoadjuvant systemic therapy. * Surgically resectable disease following neoadjuvant systemic treatment. * At least one of the following must be true: * Received at least 2 weeks of neoadjuvant endocrine therapy * Received at least 2 months of neoadjuvant chemotherapy with suggestion of residual disease on imaging * Began neoadjuvant chemotherapy or endocrine therapy but discontinued due to evidence of progressive disease by MRI, ultrasound, or physical examination * Provide written informed consent. * Willing to return to enrolling institution for breast cancer surgery. * Willingness to provide mandatory blood specimens for future research on breast cancer at Mayo Clinic. * Willingness to provide mandatory tissue specimens for future research on breast cancer at Mayo Clinic. * Willingness to provide mandatory tissue specimens for the generation of PDX and organoids to be used future research on breast cancer at Mayo Clinic. Exclusion Criteria: * Ineligible for surgery. * History of prior malignancy \<3 years prior to registration. Exceptions for non-melanoma skin cancer, papillary thyroid cancer, non-invasive cancer (e.g., carcinoma in situ of the cervix).
References
Publications (0)
Data not yet available
No reference posted for this study.