Using organoids to test chemotherapy sensitivity in breast cancer patients
Consistency of Organoids Based Drug Sensitivity and Efficacy of Neoadjuvant Chemotherapy in Breast Cancer
Second Affiliated Hospital, School of Medicine, Zhejiang University · NCT06155305
This study is testing if lab-grown mini tumors from breast cancer patients can help predict how well they will respond to chemotherapy before treatment starts.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 58 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University (other) |
| Drugs / interventions | chemotherapy, Pertuzumab, Cyclophosphamide, Doxorubicin |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06155305 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the sensitivity of neoadjuvant chemotherapy in early-stage breast cancer patients by utilizing patient-derived organoids (PDOs). A total of 58 female patients, aged 18 to 70, will be recruited and their tumor biopsies will be cultured to create organoids. These organoids will be treated with standard chemotherapy drugs, and their growth will be assessed to determine treatment efficacy. The study will also correlate the organoid responses with clinical outcomes using the Residual Cancer Burden (RCB) system to enhance understanding of individual treatment responses.
Who should consider this trial
Good fit: Ideal candidates are female patients aged 18 to 70 with early-stage breast cancer eligible for neoadjuvant chemotherapy.
Not a fit: Patients with locally advanced or inflammatory breast cancer, or those who have received prior treatments, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more personalized and effective chemotherapy regimens for breast cancer patients.
How similar studies have performed: While the use of organoids in drug sensitivity testing is gaining traction, this specific application in neoadjuvant chemotherapy for breast cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Signed informed consent form and willingness to participate in the clinical study. 2. Female patients aged between 18 and 70 years old. 3. Confirmed early-stage breast cancer eligible for surgery (AJCC stages I to IIIA), with a tumor diameter of ≥ 2cm detected by MRI and without distant metastasis (M0). The largest lesion among multiple lesions has a diameter of ≥ 2cm. 4. ECOG performance status score of 0-1. 5. No significant abnormalities in liver and kidney function (BIL \<1.5-fold upper limit of normal (ULN)；ALT\<2.5×ULN; AST\<2.5×ULN；Crea≤1×ULN). Exclusion Criteria: 1. Received prior treatments. 2. Locally advanced breast cancer not amenable to surgery or inflammatory breast cancer (AJCC stage unresectable III). 3. Bilateral breast cancer. 4. Multiple breast cancers distributed in different quadrants. 5. Patients not suitable for neoadjuvant chemotherapy.
Where this trial is running
Hangzhou, Zhejiang
- 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou, Zhejiang, China (RECRUITING)
Study contacts
- Principal investigator: Jian Huang — 2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China
- Study coordinator: ZHIGANG CHEN
- Email: chenzg@zju.edu.cn
- Phone: +8657189713716
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Organoids, Breast Cancer, Neoadjuvant Chemotherapy