Clinical trial · Interventional
Clinical Study on Drug Sensitivity Verification or Prediction of Therapy for Breast Cancer by Patient-Derived Organoid Model
NCT03544047CI-TRIAL-00036083unknownN/AClinicalTrials.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)
This is a single center, single arm, open and exploratory clinical study, with 50 cases planned for a period of 2 years. The purpose of this study is to evaluate the consistency and accuracy of Patient-Derived Organoid Model of breast cancer to predict the clinical efficacy of the drug, as well as the possibility of guiding the neoadjuvant chemotherapy.
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 |
|---|---|---|---|
| Organoid | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Experimental arm
- description
- Patient was first treated with paclitaxel (PTX) chemotherapy 3 cycles (2 weeks regimen) and Herceptin was treated in HER2 amplification patients. After 3 cycles. If the tumor continues to reduce in the first 3 cycles, continue paclitaxel chemotherapy for 3 cycles (6 weeks) and Herceptin was treated in HER2 amplification patients. If the evaluation of the curative effect is SD or PD, according to the result of drug sensitivity of the class organ, combined with the clinical practice, the doctor chooses the most sensitive treatment plan, and continues the 2 cycle treatment (6 weeks).
- interventionNames
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Overall Response rates (ORR)
- timeFrame
- up to 36 months
- description
- Defined as complete response (CR) + partial response (PR), assessed based on Response Evaluation Criteria in Solid Tumors (RECIST 1.1) criteria.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The age is more than 18 years old; * Pathology and immunohistochemical diagnosis of stage II-III breast cancer patients; * No prior treatment (such as anti-tumor therapy, immunotherapy, related surgery, etc.) may affect the outcome of the treatment; * According to the RECIST standard, the lesion was measured (the diameter of the primary lesion was greater than 1.0cm or the short diameter of the lymph node was greater than 1.5cm); * Metastatic lesions or primary lesions can obtain surgical tissue or adequate biopsy tissue; * No clinical diagnosis of other malignancies, unstable complications or uncontrolled infection; * ECOG PS score: 0-2 points; * Life expectancy is greater than 6 month; * The main organ function is normal; * The subjects volunteered to participate in this study, signed informed consent, followed up with good compliance. Exclusion Criteria: * Unable to obtain sufficient tumor organizer by operation or biopsy; * Pregnant and lactating patients; * Patients with peripheral nervous system disorder caused by disease or have significant mental disorders and history of central nervous system disorders; * Patients with severe infections or active digestive tract ulcers need to be treated; * Allergic to chemotherapy drugs or surgical contraindication; * History of other malignant tumors; * Severe liver disease (such as cirrhosis), cardiovascular disease, kidney disease, respiratory disease, blood system disease, or uncontrolled diabetes; * Participating in or participating in other clinical trials within a month.
References
Publications (0)
Data not yet available
No reference posted for this study.