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

NCT06438055 | Not Yet Recruiting

• 1 other identifier: TJBCPDO01
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Refractory Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate

  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 Outcomes (2)

• Progressive free survival

  1-2 years

• Overall survival time

  2 years

Study Arms (1)

Organoid-Guided therapy

EXPERIMENTAL

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

Interventions

Chemotherapy and targeted-therapy guided by organoid drug sensitivity test OTHER

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.

Organoid-Guided therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female, aged ≥ 18 years and ≤ 75 years old;
• Breast cancer confirmed by histology or cytology;
• 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;
• Being able to obtain sufficient fresh tissue specimens for organoid establishment through puncture;
• Expected survival time ≥ 3 months;
• The patient voluntarily joined this study and signed an informed consent form (ICF), with good compliance and cooperation in follow-up.

You may not qualify if:

• Pregnant and lactating women;
• 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;
• Individuals with a history of abuse of psychotropic drugs who are unable to quit or have mental disorders;

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead
• Kingbio Medical (Beijing) Co., Ltd.: collaborator

Related Publications (19)

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Yehui Shi, PhD

  Tianjin Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yehui Shi, PhD

CONTACT

+8618622221183; shiyehui@tjmuch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2024
• First Posted: May 31, 2024
• Study Start: June 1, 2024
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share