Organoids Based Drug Sensitivity in Neoadjuvant Chemotherapy of Breast Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-70
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

Breast cancer is the most common malignancy in women worldwide. Patients with breast cancer are often diagnosed at later stages and have a strong desire for breast conservation, necessitating neoadjuvant chemotherapy. Tumors of different molecular subtypes and individual variations among patients lead to significant differences in treatment efficacy. Precise assessment of patients' responses to treatment regimens is imperative in advancing prognosis of breast cancer. In this study, 58 patients diagnosed with breast cancer and scheduled for neoadjuvant therapy will be recruited. Patient-derived organoids from their tumor biopsies will be utilized to evaluate the sensitivity of chemotherapy regimen. These drugs primarily include Doxorubicin, Carboplatin, Cyclophosphamide, Paclitaxel, as well as targeted therapies such as Herceptin and Pertuzumab.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed informed consent form and willingness to participate in the clinical study.

Female patients aged between 18 and 70 years old.

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).

ECOG performance status score of 0-1.

Disqualifiers

Received prior treatments.

Locally advanced breast cancer not amenable to surgery or inflammatory breast cancer (AJCC stage unresectable III).

Bilateral breast cancer.

Multiple breast cancers distributed in different quadrants.

Trial population

Patients with breast cancer (AJCC stages I to IIIA) who need to receive neoadjuvant therapy.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Biopsy

    Procedure/Surgery

    Before initiating neoadjuvant therapy, patients diagnosed with breast cancer undergo a tumor biopsy. The tissue obtained from the biopsy is utilized to establish organoids and conduct drug testing.

Treatment groups

58 Participants
are divided into 1 treatment group
Group A: Breast cancer patients1 intervention

Trial outcomes

Primary outcomes

1

Correlation between drug sensitivity test results in patient-derived organoid models and clinical outcomes.

The drug sensitivity test results obtained from patient-derived organoid models will be compared with the clinical outcomes.

Time frame
2023.12-2025.06

Secondary outcomes

1

Comparison between drug sensitivity of organoid models and clinical imaging (MRI, ultrasound, BSGI) in predicting the efficacy of neoadjuvant chemotherapy.

The sensitivity and specificity would be checked between drug sensitivity of organoid models and clinical imaging (MRI, ultrasound, BSGI) in predicting the efficacy of neoadjuvant chemotherapy.

Time frame
2023.12-2025.06

Other outcomes

Sponsors and contacts

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