Clinical trial · Observational
Integrated Patient Avatars for Guiding Systemic Therapy Treatments in Metastatic Breast Cancer Patients
Integrated Patient Avatars for Guiding Systemic Therapy Treatments: "Intuition-Free" Decisions in Metastatic Breast Cancer Patients
NCT04608357CI-TRIAL-00084872recruitingClinicalTrials.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)
The investigators propose to use clinically validated patient avatar technology ("PDXovo") that can test multiple drugs against patients' cancers to identify the most promising systemic therapy for each individual.
Conditions
Conditions (4)
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 |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Needle Core Biopsies | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Determine the tumor take rate in PDX
- timeFrame
- 7-10 days
- description
- perform a feasibility study to determine the tumor take rate(s) in PDXs generated from needle core biopsies collected from metastatic breast cancer patients
Secondary outcomes (1)
- measure
- Compare response rates of PDXs & with that of the patient from whom the PDX was derived
- timeFrame
- 8 to 16 weeks
- description
- The response of PDXs will be compared to the patient's response to systemic therapy, as measured using the objective response rate.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18+. 2. Metastatic breast cancer irrespective of subtype. 3. Measurable disease as per RECIST 1.1 criteria. 4. Metastatic disease involving the lymph nodes and/or visceral organs is required. 5. Willingness to undergo a biopsy prior to the start of planned systemic therapy. Exclusion Criteria: 1. Lack of feasibility to obtain a core biopsy of a metastatic site other than the bone (e.g. a metastatic lesion cannot be safely sampled due to proximity to vasculature). 2. Inability to provide informed consent.
References
Publications (1)
- DERIVEDGrafinger OR, Hayward JJ, Meng Y, Geddes-McAlister J, Li Y, Mar S, Sheng M, Su B, Thillainadesan G, Lipsman N, Coppolino MG, Trant JF, Jerzak KJ, Leong HS. Cancer cell extravasation requires iplectin-mediated delivery of MT1-MMP at invadopodia. Br J Cancer. 2024 Sep;131(5):931-943. doi: 10.1038/s41416-024-02782-9. Epub 2024 Jul 5. PMID 38969866