Clinical trial · Interventional
PTC Guiding Neoadjuvant Treatment in Breast Cancer
Neoadjuvant Therapy for Breast Cancer Based on Patient-derived Tumor-like Cell Clusters Advanced Drug Sensitization Regimens: a Phase II Randomized Controlled Clinical Study
- 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)
Patients with breast cancer meet criteria for enrollment are randomized into PTC group or control group. The neoadjuvant therapy regimens are guided by PTC test in the PTC group. The regimens in control group are included of (dd)EC-T for HER2 negative subtype, TCH(P) or EC-TH(P) for HER2 positive subtype. We compared the pCR rate between two groups as the primary endpoint.
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 |
|---|---|---|---|
| Pathological Conditions, Signs and Symptoms | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| patient-derived tumor-like cell clusters drug sensitivity test | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PTC group
- description
- Patients randomized into this group receiving PTC test and choose regimens according to this test results
- interventionNames
- Diagnostic Test: patient-derived tumor-like cell clusters drug sensitivity test
- type
- NO_INTERVENTION
- label
- Control group
- description
- Patients randomized into this group receiving routine regimens according to subtypes
Primary outcomes (2)
- measure
- pCR rate
- timeFrame
- one month after operation
- description
- pathological complete response
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female between 18 to 70 years old. 2. Patients diagnosed with invasive breast cancer by pathology. 3. Clinical stage considered as T2-4N0-2M0 . 4. HER2 overexpression by IHC or FISH positive. 5. Patients plan to accept neoadjuvant therapy or plan to accept adjuvant therapy after neoadjuvant therapy and surgery. Exclusion Criteria: 1. Patients have already accepted any other anti-tumor treatment not included in our project. 2. Patients with metastasis are not considered surgery therapy. 3. Patients cannot accept chemotherapy or anti-HER2 targeted therapy, because of severe cardiovascular diseases or other reasons
References
Publications (0)
Data not yet available