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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer

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

Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer (NCT06268652) is a Phase 3 interventional studying Breast Cancer and Refractory Breast Carcinoma, sponsored by Sun Yat-sen University. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Breast Cancer, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 302 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Voluntarily participate and sign the willing to sign a consent form form 2. Aged over 18 years old, regardless of gender; 3. Locally advanced or metastatic breast cancer confirmed by histopathology; 4. Received ≥2 previous lines of anti-tumor treatment and developed resistance to standard treatment; 5. Life expectancy ≥3 months; 6. You should be able to carry out daily activities with 0 level of ability (ECOG 0) to 2; 7. Have measurable or/and evaluable lesions (non-radiotherapy target areas) (lesion evaluation is based on Recist1.1 standards); 8. No serious organ (main organ: heart, lung, liver, kidney) functional abnormalities (refer to respective standards); 9. 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; 10. 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 11. Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN (unless warfarin is being used for anticoagulation); 12. Able to comply with the research visit plan and other program requirements; 13. 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: 1. No absolute contraindications to tissue-invasive procedures required to obtain organoid cultures。 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Voluntarily participate and sign the informed consent form 2. Aged over 18 years old, regardless of gender; 3. Locally advanced or metastatic breast cancer confirmed by histopathology; 4. Received ≥2 previous lines of anti-tumor treatment and developed resistance to standard treatment; 5. Life expectancy ≥3 months; 6. ECOG performance status 0 to 2; 7. Have measurable or/and evaluable lesions (non-radiotherapy target areas) (lesion evaluation is based on Recist1.1 standards); 8. No serious organ (main organ: heart, lung, liver, kidney) functional abnormalities (refer to respective standards); 9. 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; 10. 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 11. Coagulation function: prothrombin time (PT), international normalized ratio (INR) ≤ 1.5 × ULN (unless warfarin is being used for anticoagulation); 12. Able to comply with the research visit plan and other program requirements; 13. 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: 1. No absolute contraindications to tissue-invasive procedures required to obtain organoid cultures。 2. 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. Exclusion Criteria: 1. The medical history and comorbidities are as follows: 1. 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; 2. Other active malignant tumors that require simultaneous treatment; 3. Known history of organ transplantation and allogeneic hematopoietic stem cell transplantation; 4. 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; 5. 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; 6. Severe acute or chronic infection requiring systemic treatment 7. 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. 2. Pregnant or lactating women. 3. No anti-tumor treatment is planned. 4. Known to have a positive history of human immunodeficiency virus (HIV) test or known to have acquired immunodeficiency syndrome (AIDS); 5. 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; 6. Hypersensitivity to any study drug;

Treatments Being Tested

OTHER

Organoid-guided personalized treatment

After the organoid culture is successful, the personalized drug library customized by our team will be used for screening. Sensitive drugs are selected based on the results of drug screening, and the most appropriate personalized treatment plan is selected based on NCCN guideline recommendations, drug safety, and conventional drugs used in the treatment of breast cancer. The personalized drug library customized by our team contains 55 drugs approved by the FDA. For specific usage, dosage and time intervals, please refer to the instructions of the corresponding drug.

DRUG

Gemcitabine

1000mg/m2,IV, days 1, 8, q3w

DRUG

Capecitabine

1000mg/m² , PO, bid, days1-14, q3w

DRUG

Vinorelbine

25mg/m2, IV or 60mg/m² (oral), days 1 and 8, q3w

DRUG

Eribulin

1.4mg/m², IV, days 1 and 8, q3w

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Yanxia Shi
Guangzhou, None Selected, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06268652), the sponsor (Sun Yat-sen University), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06268652 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06268652?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06268652?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06268652. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06268652. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.