Prediction of treatment response based on drug sensitivity of breast cancer stem cells derived from patient breast cancer tissue with spheroid culture methodPrediction of treatment response based on drug sensitivity of breast cancer stem cells derived from patient breast cancer tissue with spheroid culture method

Prediction of treatment response based on drug sensitivity of breast cancer stem cells derived from patient breast cancer tissue with spheroid culture method - Prediction of treatment response based on drug sensitivity of breast cancer stem cells derived from patient breast cancer tissue with spheroid culture method

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055390

Enrollment

200

Registered

2024-09-01

Start date

2024-09-10

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Must be 18 years of age or older at the time of consent. Patients undergoing a mammotome biopsy for a tumor measuring 2cm or larger, or undergoing curative surgery for diagnosed invasive breast cancer. Must have provided written informed consent for participation in the study.

Exclusion criteria

Exclusion criteria: Individuals with another malignant disease. Deemed inappropriate for the study by the principal investigator or co-investigators.

Design outcomes

Primary

Measure	Time frame
Spheroid culture is performed using breast cancer tissue derived from patient tissues, and cultured cells are used for drug sensitivity testing. A small number of three-dimensional cultured cells will be used in the MT Cell Viability Assay, which utilizes the luciferase reaction and allows measurement over time. The IC50 of each drug will be calculated, and the primary endpoint will be analyzed in relation to the pCR in preoperative chemotherapy patients and the CB in postoperative relapse patients. Specifically, the IC50 threshold for each drug that yields pCR or CB will be determined from the data of 200 planned cases and used to predict treatment efficacy. If more than one drug is used, the model that best predicts the treatment effect is determined based on the IC50 of a single drug or a combination of multiple drugs (training data set). We intend to conduct clinical trials (validation data set) in the future using the models determined here.	—

Measure

Time frame

Spheroid culture is performed using breast cancer tissue derived from patient tissues, and cultured cells are used for drug sensitivity testing. A small number of three-dimensional cultured cells will be used in the MT Cell Viability Assay, which utilizes the luciferase reaction and allows measurement over time. The IC50 of each drug will be calculated, and the primary endpoint will be analyzed in relation to the pCR in preoperative chemotherapy patients and the CB in postoperative relapse patients. Specifically, the IC50 threshold for each drug that yields pCR or CB will be determined from the data of 200 planned cases and used to predict treatment efficacy. If more than one drug is used, the model that best predicts the treatment effect is determined based on the IC50 of a single drug or a combination of multiple drugs (training data set). We intend to conduct clinical trials (validation data set) in the future using the models determined here.

—

Countries

Japan

Contacts

Public ContactYoshiko Miyazaki

Shimane Uiniversity Faculty of Medicine Depertment of Digestive and General Surgery

miya445@med.shimane-u.ac.jp0853-20-2232

Outcome results