Clinical Treatment of Refractory Breast Cancer Based on Organoid Drug Sensitivity Results
NCT ID: NCT06438055
Last Updated: 2024-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
40 participants
INTERVENTIONAL
2024-06-30
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
FEMALE
No
Sponsors
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Kingbio Medical (Beijing) Co., Ltd.
UNKNOWN
Tianjin Medical University Cancer Institute and Hospital
OTHER
Responsible Party
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Principal Investigators
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Yehui Shi, PhD
Role: PRINCIPAL_INVESTIGATOR
Tianjin Cancer Hospital
Central Contacts
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References
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Lei S, Zheng R, Zhang S, Chen R, Wang S, Sun K, Zeng H, Wei W, He J. Breast cancer incidence and mortality in women in China: temporal trends and projections to 2030. Cancer Biol Med. 2021 May 18;18(3):900-9. doi: 10.20892/j.issn.2095-3941.2020.0523.
Potter DA, Herrera-Ponzanelli CA, Hinojosa D, Castillo R, Hernandez-Cruz I, Arrieta VA, Franklin MJ, Yee D. Recent advances in neoadjuvant therapy for breast cancer. Fac Rev. 2021 Jan 4;10:2. doi: 10.12703/r/10-2. eCollection 2021.
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Eiraku M, Watanabe K, Matsuo-Takasaki M, Kawada M, Yonemura S, Matsumura M, Wataya T, Nishiyama A, Muguruma K, Sasai Y. Self-organized formation of polarized cortical tissues from ESCs and its active manipulation by extrinsic signals. Cell Stem Cell. 2008 Nov 6;3(5):519-32. doi: 10.1016/j.stem.2008.09.002.
Romero-Calvo I, Weber CR, Ray M, Brown M, Kirby K, Nandi RK, Long TM, Sparrow SM, Ugolkov A, Qiang W, Zhang Y, Brunetti T, Kindler H, Segal JP, Rzhetsky A, Mazar AP, Buschmann MM, Weichselbaum R, Roggin K, White KP. Human Organoids Share Structural and Genetic Features with Primary Pancreatic Adenocarcinoma Tumors. Mol Cancer Res. 2019 Jan;17(1):70-83. doi: 10.1158/1541-7786.MCR-18-0531. Epub 2018 Aug 31.
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Other Identifiers
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TJBCPDO01
Identifier Type: -
Identifier Source: org_study_id