## Protocol Section
### Identification Module
**NCT ID:** NCT06438055

**Brief Title:** Clinical Treatment of Refractory Breast Cancer Based on Organoid Drug Sensitivity Results

**Official Title:** Clinical Treatment of Refractory Breast Cancer Based on Organoid Drug Sensitivity Results

#### Organization Study ID Info
**ID:** TJBCPDO01
#### Organization
**Class:** OTHER
**Full Name:** Tianjin Medical University Cancer Institute and Hospital
### Status Module
#### Completion Date
**Date:** 2026-06

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-26

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2025-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-26
**Study First Submit QC Date:** 2024-05-26
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Kingbio Medical (Beijing) Co., Ltd.

#### Lead Sponsor

**Class:** OTHER

**Name:** Tianjin Medical University Cancer Institute and Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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.

### Conditions Module

**Conditions:**

- Refractory Breast Cancer

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** All patients will be included in a single-arm. Participants will undergo biopsy of tumor tissue for subsequent organoid generation and drug sensitivity tests.

**Intervention Names:**

- Other: Chemotherapy and targeted-therapy guided by organoid drug sensitivity test

**Label:** Organoid-Guided therapy

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Organoid-Guided therapy

**Description:** 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.

**Name:** Chemotherapy and targeted-therapy guided by organoid drug sensitivity test

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Percentage of patient's measurable disease who have achieved either complete response (CR) or partial response (PR) according to RECIST 1.1.

**Measure:** Objective Response Rate

**Time Frame:** 1-2 years

#### Secondary Outcomes

**Description:** The time from initiation of treatment to the occurrence of disease progression or death.

**Measure:** Progressive free survival

**Time Frame:** 1-2 years

**Description:** 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.

**Measure:** Overall survival time

**Time Frame:** 2 years

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** shiyehui@tjmuch.com

**Name:** Yehui Shi, PhD

**Phone:** +8618622221183

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Tianjin Cancer Hospital

**Name:** Yehui Shi, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

### References Module

#### References

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**PMID:** 33734139

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**PMID:** 34002584

**Citation:** 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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## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M10018

- Name: Hypersensitivity

- Relevance: LOW

- As Found: Unknown

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

### Misc Info Module

- Version Holder: 2024-05-31
