Clinical Treatment of Refractory Breast Cancer Based on Organoid Drug Sensitivity Results

May 26, 2024 updated by: Tianjin Medical University Cancer Institute and Hospital
This study aims to enroll refractory breast cancer patients. Patient-derived organoid will be established, and drug sensitivity test will be conducted to intervene in the selection of clinical treatment plans. Efficacy evaluation and prognosis analysis will also be conducted. It is hoped that this study will provide a basis for the development of personalized treatment plans.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Forty patients with refractory breast cancer who met the inclusion criteria were enrolled in the study after signing an informed consent form. Tumor samples were obtained through clinical puncture, and qualified samples were subjected to organoid modeling. Perform drug sensitivity test on the established breast cancer organoids. The drugs used are all that have been marketed and applied in clinical practice. According to the results of organoid drug sensitivity analysis, the patient received a treatment plan with relatively sensitive drugs. Follow up prognostic data and relevant clinical information of enrolled patients, conduct statistical analysis on the consistency between drug sensitivity test results and patient treatment response, and evaluate the clinical effectiveness of treatment plans guided by organoid drug sensitivity results.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Female, aged ≥ 18 years and ≤ 75 years old;
  2. Breast cancer confirmed by histology or cytology;
  3. One of the following two conditions shall be met: a) Operable breast cancer: Recurrent progression during adjuvant therapy; or the time from initial treatment to the onset of disease progression is less than or equal to 2 years; b) Non-operable breast cancer: patients who have changed two line treatment plans within 6 months;
  4. Being able to obtain sufficient fresh tissue specimens for organoid establishment through puncture;
  5. Expected survival time ≥ 3 months;
  6. The patient voluntarily joined this study and signed an informed consent form (ICF), with good compliance and cooperation in follow-up.

Exclusion Criteria:

  1. Pregnant and lactating women;
  2. Patients who have clinically significant (i.e. active) heart disease (such as congestive heart failure, symptomatic coronary artery disease, arrhythmia, etc.) or myocardial infarction within the past 12 months;
  3. Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;
  4. The researchers believe that patients are not suitable for inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Organoid-Guided therapy
All patients will be included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation and drug sensitivity tests.
Other: Chemotherapy and targeted-therapy guided by organoid drug sensitivity test
This study conducts drug sensitivity tests on various clinically approved drugs. The most sensitive drug for the patient is selected for treatment. This study aims to evaluate the clinical effectiveness of treatment plans guided by organoid drug sensitivity tests.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate
Time Frame: 1-2 years
Percentage of patient's measurable disease who have achieved either complete response (CR) or partial response (PR) according to RECIST 1.1.
1-2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progressive free survival
Time Frame: 1-2 years
The time from initiation of treatment to the occurrence of disease progression or death.
1-2 years
Overall survival time
Time Frame: 2 years
The time from the date of randomization to the date of death for any cause. Patients will be followed until their date of death or until final database closure.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborators

Kingbio Medical (Beijing) Co., Ltd.

Investigators

  • Principal Investigator: Yehui Shi, PhD, Tianjin Cancer Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2024

Primary Completion (Estimated)

June 1, 2025

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

May 26, 2024

First Submitted That Met QC Criteria

May 26, 2024

First Posted (Actual)

May 31, 2024

Study Record Updates

Last Update Posted (Actual)

May 31, 2024

Last Update Submitted That Met QC Criteria

May 26, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TJBCPDO01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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