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

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 design

Treatments tested in this trial

  • Biopsy

Treatment groups

58 Participants
are divided into 1 treatment group