Using organoids to test chemotherapy sensitivity in breast cancer patients
Official title: Consistency of Organoids Based Drug Sensitivity and Efficacy of Neoadjuvant Chemotherapy in Breast Cancer
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT06155305 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 58 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, Pertuzumab, Cyclophosphamide, Doxorubicin |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | December 6, 2023 |
| Main results expected | December 1, 2025 |
| Study ends | December 1, 2025 |
| Registry record updated | January 7, 2025 |
| Trial ID | NCT06155305 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are female patients aged 18 to 70 with early-stage breast cancer eligible for neoadjuvant chemotherapy.
✕Probably not a fit
Patients with locally advanced or inflammatory breast cancer, or those who have received prior treatments, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the use of organoids in drug sensitivity testing is gaining traction, this specific application in neoadjuvant chemotherapy for breast cancer is relatively novel.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Characterizing breast cancer subtypes using patient-derived organoids
This study is testing if lab-grown mini-tumors from breast cancer patients can help doctors figure out which chemotherapy works best for people with triple-negative breast cancer or those whose cancer has come back.
-
Non-surgical treatment for breast cancer after chemotherapy
This study tests if using radiotherapy alone is a safe and effective option for breast cancer patients who have responded well to chemotherapy, instead of undergoing surgery.
-
Using advanced mammography techniques to assess breast cancer treatment response
This study is testing two new mammography techniques to see if they can better predict how well chemotherapy is working for people with locally advanced breast cancer.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.