Actively Recruiting

Age: 18Years - 70Years
FEMALE
NCT06155305

Organoids Based Drug Sensitivity in Neoadjuvant Chemotherapy of Breast Cancer

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-01-07

58

Participants Needed

1

Research Sites

103 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Organoids Based Drug Sensitivity in Neoadjuvant Chemotherapy of Breast Cancer

Who Can Participate

Age: 18Years - 70Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 or more detected by MRI and no distant metastasis (M0).
  • If multiple lesions are present, the largest lesion must have a diameter of 2cm or more.
  • ECOG performance status score of 0-1.
  • No significant abnormalities in liver and kidney function (bilirubin <1.5 times upper limit of normal; ALT and AST <2.5 times upper limit of normal; creatinine 2 times upper limit of normal).
Not Eligible

You will not qualify if you...

  • Received prior treatments.
  • Locally advanced breast cancer not suitable for surgery or inflammatory breast cancer (unresectable AJCC stage III).
  • Bilateral breast cancer.
  • Multiple breast cancers in different quadrants.
  • Not suitable for neoadjuvant chemotherapy.

AI-Screening

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Trial Site Locations

Total: 1 location

1

2 nd Affiliated Hospital, School of Medicine, Zhejiang University, China

Hangzhou, Zhejiang, China, 310009

Actively Recruiting

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Research Team

Z

ZHIGANG CHEN

CONTACT

J

Jian Huang

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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