Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Patients With Relapsed and Refractory Breast Cancer:a Multicenter, Randomized, Controlled Phase III Trial

Status: Recruiting
Location: See location...
Intervention Type: Drug, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
China
Yanxia Shi
RECRUITING
Guangzhou
Contact Information
Primary
Yanxia Shi
shiyx@sysucc.org.cn
020-87343368
Time Frame
Start Date: 2024-01-15
Estimated Completion Date: 2028-01-15
Participants
Target number of participants: 302
Treatments
Experimental: Organoid-guided personalized treatment
Subjects randomly assigned to OGPT need to provide sufficient tissue for organoid culture. After successful organoid culture, drug screening will be performed, and they will be treated with drugs predicted to be sensitive by PDO drug susceptibility screening.
Active_comparator: Treatment of physician's choice
Subjects in the TPC arm will receive treatment with one of the following regimens selected by the physician following NCCN guidelines: capecitabine, gemcitabine, vinorelbine, and eribulin. If it is HER2-positive, anti-HER2 therapy can be combined with it, except for ADC drugs.
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University

This content was sourced from clinicaltrials.gov