Clinical Exploratory Study on Predicting Drug Sensitivity for Breast Cancer Treatment Using Simulated Organoid Models.

NCT06702800 | Recruiting DMC

• 1 other identifier: 1106852441
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In this trial, we plan to construct a patient-derived organoid (PDO) model using fresh tumor tissue samples. Taking the relevant data of drug efficacy of breast cancer organoids as an example, it is shown that organoids may provide predictive information for drug sensitivity and may improve the therapeutic effect of advanced tumors. In this way, we aim to verify the effectiveness, feasibility and consistency of the PDO model in predicting treatment, and establish an evaluation system for treatment plans to help precision treatment of breast cancer.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate（ORR).

  The proportion defined as subjects with complete remission (CR) and partial remission (PR) among all subjects.

  2024-06-02 to 2026-05-31

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer

You may not qualify if:

• According to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1), there is at least one measurable lesion; the expected survival time is ≥ 12 weeks.
• Voluntarily sign the informed consent form, and be willing and able to comply with the follow - up, treatment, laboratory tests, and other research requirements specified in the research schedule.
• Positive human immunodeficiency virus (HIV) test or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
• Other serious diseases that are judged to potentially affect follow - up and short - term survival of the patient.
• Inability to swallow, chronic diarrhea, and intestinal obstruction, with various factors affecting drug intake and absorption.
• Known allergy to the potentially used treatment drugs. Adverse reactions of grade ≥ 1 that are still ongoing due to previous treatments. Exceptions are alopecia or cases that the researcher deems should not be excluded. Such cases should be clearly recorded in the investigator's notes.
• Female patients who are pregnant, breastfeeding, or planning to become pregnant during the study period (pregnancy tests should be considered for sexually active women of child - bearing age).
• Having had other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.
• Urinalysis shows urine protein ≥ 2+ or confirmed 24 - hour urine protein quantification \> 1.0g; presence of any autoimmune diseases that still require treatment or a history of autoimmune diseases, excluding hypothyroidism caused by autoimmune thyroiditis that only requires hormone replacement therapy and type 1 diabetes with controllable and stable blood sugar.
• Patients with hypertension that cannot be well - controlled with a single antihypertensive drug (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg); history of unstable angina pectoris; newly diagnosed angina pectoris within 3 months before screening or myocardial infarction event within 6 months before screening; arrhythmia (including QTcF: ≥ 450 ms for men and ≥ 470 ms for women) requiring long - term use of anti - arrhythmic drugs and New York Heart Association class ≥ II heart failure.
• Other situations that researchers evaluate as potentially endangering the patient's safety or having poor compliance, such as having serious diseases (including mental diseases), severely abnormal test results, and other high - risk factors in the family or society.
• Currently receiving or planning to receive anti - tumor drug treatment, regardless of the number of treatment lines.
• According to the Response Evaluation Criteria in Solid Tumors (RECIST1.1), there is at least one measurable lesion; the expected survival time is ≥ 12 weeks.
• (Note: For subjects with some chronic and stable grade 2 toxicities that the researcher deems related to previous anti - tumor treatments (such as chemotherapy - induced neuropathy), a decision on whether to include the subject in this study will be made after discussion with the medical monitor.) For female subjects with child - bearing potential and male subjects whose partners have reproductive potential, effective medical contraceptive measures should be taken during the research treatment period and within 6 months after the end of drug administration.
• Voluntarily sign the informed consent form, and be willing and able to comply with the follow - up, treatment, laboratory tests, and other research requirements specified in the research schedule.

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

Study Sites (1)

Xiangya Hospital

Changsha, Hunan, 410000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Consist of tumor tissue samples obtained by puncture from patients with advanced breast cancer and 5 ml of venous blood samples.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

jun Huang, doctor

CONTACT

18229944886; 404369@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2024
• First Posted: November 25, 2024
• Study Start: June 1, 2024
• Primary Completion: May 31, 2025
• Study Completion: May 30, 2026
• Last Updated: March 3, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)