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A prospective real-world study using patient-derived organoids to predict the efficacy of combination therapy for breast cancer

A prospective real-world study using patient-derived organoids to predict the efficacy of combination therapy for breast cancer

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300077943
Enrollment
Unknown
Registered
2023-11-24
Start date
2023-11-27
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

breast cancer

Interventions

Case series:none

Sponsors

The First Hospital Affiliated to the Army Military Medical University of the Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-75 years; (2) Stage I-III breast cancer patients receiving neoadjuvant therapy or direct surgery followed by postoperative adjuvant therapy or recurrent metastatic stage IV breast cancer patients receiving relief therapy; (3) With clear primary or recurrent metastatic lesions feasible tissue aspiration biopsy or excision; (4) Expected survival greater than 3 months; (5) ECOG physical fitness score of 0-1; (6) KPS score greater than 60; (7) Bone marrow function: neutrophils =1.5×109/L, platelets =100×109/L, hemoglobin =90g/L; (8) Liver and renal function: serum creatinine =1.5 times the upper limit of normal; AST and ALT =2.5 times the upper limit of normal; total bilirubin =1.5 times the upper limit of normal or =2.5 times the upper limit of normal if the patient has Gilbert's syndrome; (9) Patients must have the ability to understand and voluntarily sign an informed consent form;

Exclusion criteria

Exclusion criteria: (1) Patients with class II or higher heart disease (including class II) as determined by the New York Heart Association (NYHA) score; (2) Patients with severe systemic infections or with other serious diseases; (3) Patients with known allergy or intolerance to chemotherapeutic agents or their excipients; (4) Other malignant tumors within the past 5 years, except cured carcinoma in situ of the uterine cervix and non-melanoma skin cancer; (5) Pregnant or breastfeeding, as well as patients of childbearing age who refuse to take appropriate contraceptive measures during the course of this trial; (6) Participation in another experimental study within 30 days prior to the first administration of study drug; (7) Patients who, in the judgment of the investigator, are not suitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Objective response rate;

Secondary

MeasureTime frame
pathology complete response rate;

Countries

China

Contacts

Public ContactXiaowei Qi

The First Hospital Affiliated to the Army Military Medical University of the Chinese People's Liberation Army

qxw9908@foxmail.com+86 135 2754 5423

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026