Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer
Recruiting now · Phase 3
Conditions studied: Breast Cancer, Refractory Breast Carcinoma
In brief
This multicenter, open-label, randomized phase III trial is designed to study the efficacy and safety of organoid-guided personalized treatment （OGPT）versus treatment of physician's choice (TPC) in previously treated refractory breast cancer.
Key facts
- Study ID
- NCT06268652
- Run by
- Sun Yat-sen University
- People needed
- 302
- Starts
- 2024-01-15
- Expected to finish
- 2028-01-15
- Last updated by the study team
- 2024-02-20
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Voluntarily participate and sign the informed consent form
- Aged over 18 years old, regardless of gender;
- Locally advanced or metastatic breast cancer confirmed by histopathology;
- Received ≥2 previous lines of anti-tumor treatment and developed resistance to standard treatment;
- Life expectancy ≥3 months;
- ECOG performance status 0 to 2;
- Have measurable or/and evaluable lesions (non-radiotherapy target areas) (lesion evaluation is based on Recist1.1 standards);
- No serious organ (main organ: heart, lung, liver, kidney) functional abnormalities (refer to respective standards);
- Routine blood test: white blood cells (WBC) ≥3 × 109/L; absolute neutrophil count (ANC) ≥1.5 × 109/L; platelets (PLT) ≥100 × 109/L; hemoglobin (Hgb) ≥8g /dL;
- Blood biochemical indicators: AST (SGOT), ALT (SGPT) ≤ 2.5 × upper limit of normal value (ULN) (in the case of no liver invasion) or ≤ 5 × upper limit of normal value (ULN) (in the case of liver invasion) Bottom); total bilirubin (TBIL) ≤ ULN; serum creatinine clearance calculated according to the CG formula > 30 mL/min
- Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN (unless warfarin is being used for anticoagulation);
- Able to comply with the research visit plan and other program requirements;
- All patients of childbearing age must agree to take effective contraceptive measures during the study and within 6 months of stopping treatment. Female patients of childbearing age must have a negative urine pregnancy test before treatment.
- Subjects must meet all of the following additional criteria to be included in the OGPT group:
- No absolute contraindications to tissue-invasive procedures required to obtain organoid cultures。
- Sufficient tissue can be provided for organoid culture: biopsy samples (length >1cm, 3 strips), surgical resection samples (total volume >1cm3, weight >0.2g), thoracentesis, abdominal puncture, pericardiocentesis and other malignant effusion samples (pleural effusion >500mL, ascites >500m) and confirmed to contain malignant tumor cells.
You may not qualify if…
- The medical history and comorbidities are as follows:
- The patient is participating in other interventional clinical studies or the end of treatment in the previous clinical study is less than 4 weeks;（2）Those who have been treated less than 4 weeks since the last anti-tumor treatment (radiotherapy, chemotherapy, targeted therapy, immunotherapy or local-regional treatment); the adverse reactions related to anti-tumor treatment (except alopecia) after previous systemic anti-tumor treatment have not returned to NCI- Patients with CTC AE ≤ grade 1;
- Other active malignant tumors that require simultaneous treatment;
- Known history of organ transplantation and allogeneic hematopoietic stem cell transplantation;
- For subjects who have undergone major surgery or severe trauma, the effects of the surgery or trauma have been eliminated for less than 14 days before enrollment;
- Patients with active pulmonary tuberculosis need to be excluded. Patients suspected of having active pulmonary tuberculosis should have chest X-rays, sputum, and clinical symptoms and signs to rule out the disease. Patients with a history of active pulmonary tuberculosis infection within the previous year must be excluded, even if they have been treated; patients with a history of active pulmonary tuberculosis infection more than 1 year ago must also be excluded, unless it is proven that the course and type of anti-tuberculosis treatment previously used are satisfactory. appropriate;
- Severe acute or chronic infection requiring systemic treatment
- Suffering from heart failure (New York Heart Association Class III or IV) and despite receiving appropriate medical treatment, poorly controlled coronary artery disease or arrhythmia, or a history of myocardial infarction within 6 months before screening patient.
- Pregnant or lactating women.
- No anti-tumor treatment is planned.
- Known to have a positive history of human immunodeficiency virus (HIV) test or known to have acquired immunodeficiency syndrome (AIDS);
- Untreated active hepatitis (hepatitis B: HBsAg positive and HBV DNA ≥ 500IU/mL; hepatitis C: HCV RNA positive and abnormal liver function); combined with hepatitis B and hepatitis C co-infection;
- Hypersensitivity to any study drug;
Where it is running
- Yanxia Shi — Guangzhou, None Selected, China (enrolling)
Full record on ClinicalTrials.gov
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