RecruitingNCT06702800

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

Sponsor

Xiangya Hospital of Central South University

Enrollment

30 participants

Start Date

Jun 1, 2024

Study Type

OBSERVATIONAL

Conditions

Breast Neoplasms

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.

Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

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.
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.

Exclusion Criteria22

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.
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 may lead to 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.
Pregnant or breastfeeding women (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.
Occurrence of abdominal fistula, gastrointestinal perforation, or abdominal abscess within 28 days before participating in this study.
Urinalysis shows urine protein ≥ ++ or confirmed 24 - hour urine protein quantification \> 1.0g.
Patients with hypertension that cannot be reduced to the normal range with antihypertensive drugs (systolic blood pressure \> 140mmHg, diastolic blood pressure \> 90mmHg).
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.
Criteria for Sample Exclusion
If a test sample meets any of the following criteria, it must be excluded:
Samples with unsuccessful PDO culture. Samples contaminated or failed due to improper operation during the test. Samples with lost data. Samples from patients who withdraw their informed consent and do not want to leave their samples.