Breast CancerPhase 3NCT06268652
Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer
A Phase 3 study testing Organoid-guided personalized treatment, Gemcitabine and Capecitabine in people with Breast Cancer and Refractory Breast Carcinoma, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Refractory Breast Carcinoma
- What is being tested?
- Organoid-guided personalized treatment, Gemcitabine and Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteChina
- Study dates
- 15 Jan 2024to 15 Jan 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Yanxia Shi
Guangzhou, None Selected, 510060
Yanxia Shi, 020-87343368, shiyx@sysucc.org.cn
About this study
Official title: 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
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.
Read the detailed description
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. Molecular subtype, presence of visceral metastases, and number of prior chemotherapy treatments for advanced or metastatic disease will stratify randomization. subjects in the OGPT arm will receive the treatment predicted to be the most effective by PDO drug sensitivity screening, and subjects in the TPC arm will receive treatment of physician's choice. The primary population to be included in the study will be patients with refractory breast cancer who have received multiple lines of prior therapy and who have at least one measurable target lesion according to RECIST 1.1 criteria.
- Conditions
- Breast Cancer, Refractory Breast Carcinoma
- Being tested
- Organoid-guided personalized treatment, Gemcitabine, Capecitabine, Vinorelbine, Eribulin
- Keywords
- breast cancer, TPC, patient derived organoid, PDO
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organoid-guided personalized treatmentOther
Also called OGPT
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.
GemcitabineDrug
Also called Gemzar
1000mg/m2，IV, days 1, 8, q3w
CapecitabineDrug
Also called Xeloda
1000mg/m² , PO, bid, days1-14, q3w
VinorelbineDrug
Also called Navelbine
25mg/m2, IV or 60mg/m² (oral), days 1 and 8, q3w
EribulinDrug
Also called Halaven
1.4mg/m², IV, days 1 and 8, q3w
| Study group | Role | What they receive |
|---|---|---|
| Organoid-guided personalized treatment | Experimental | 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. Receives: Other: Organoid-guided personalized treatment |
| Treatment of physician's choice | Active comparator | 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. Receives: Drug: Gemcitabine; Drug: Capecitabine; Drug: Vinorelbine; Drug: Eribulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival (PFS)
Progression-free survival (PFS) is defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of radiographic progressive disease (PD) or death due to any cause.
Measured: Within approximately 48 months
Secondary outcomes (5)
Overall Survival (OS)
Overall survival (OS) is defined as the time from the date of first dose to the date of death from any cause.
Measured: Within approximately 48 months
Objective Response Rate (ORR)
The number of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through discontinuation of treatment. Objective response rate (ORR) was defined as the proportion of participants who achieved a best overall response of complete response or partial response based on local radiologists/investigators' tumor assessments.
Measured: Within approximately 48 months
Duration of Response (DOR)
Duration of response was defined as the time interval between the date of first documentation of objective response (CR or PR) and the date of the first objective documentation of disease progression or death due to any cause.
Measured: Within approximately 48 months
Disease Control Rate (DCR)
Disease Control Rate (DCR) was defined as the percentage of patients who have achieved complete response, partial response and stable disease
Measured: Within approximately 48 months
Incidence of Treatment-related Adverse Events
Incidence of Treatment-related Adverse Events as assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).
Measured: Within approximately 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Jan 2024
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shi Yanxia, Sun Yat-sen University
- Investigators
- Yanxia Shi, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268652
- Sponsor's protocol ID
- B2023-686-01
- Status last verified
- Feb 2024
- First submitted
- 23 Jan 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06268652
- Acronym / sponsor ID
- B2023-686-01
- Conditions
- Breast Cancer, Refractory Breast Carcinoma
- Keywords
- breast cancer, TPC, patient derived organoid, PDO
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. Molecular subtype, presence of visceral metastases, and number of prior chemotherapy treatments for advanced or metastatic disease will stratify randomization. subjects in the OGPT arm will receive the treatment predicted to be the most effective by PDO drug sensitivity screening, and subjects in the TPC arm will receive treatment of physician's choice. The primary population to be included in the study will be patients with refractory breast cancer who have received multiple lines of prior therapy and who have at least one measurable target lesion according to RECIST 1.1 criteria.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Organoid-guided personalized treatment | Experimental | Other: Organoid-guided personalized treatmentSubjects 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. |
| Treatment of physician's choice | Active comparator | Drug: Gemcitabine, Drug: Capecitabine, Drug: Vinorelbine, Drug: EribulinSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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;
Key exclusion criteria (13 listed)
- The medical history and comorbidities are as follows:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Organoid-guided personalized treatmentAlso: OGPTAfter 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. | Other | Organoid-guided personalized treatment |
| GemcitabineAlso: Gemzar1000mg/m2，IV, days 1, 8, q3w | Drug | Treatment of physician's choice |
| CapecitabineAlso: Xeloda1000mg/m² , PO, bid, days1-14, q3w | Drug | Treatment of physician's choice |
| VinorelbineAlso: Navelbine25mg/m2, IV or 60mg/m² (oral), days 1 and 8, q3w | Drug | Treatment of physician's choice |
| EribulinAlso: Halaven1.4mg/m², IV, days 1 and 8, q3w | Drug | Treatment of physician's choice |
Primary outcome
Progression-free survival (PFS)
Time frame: Within approximately 48 months
Progression-free survival (PFS) is defined as the time from the date of the first dose to the earlier of the dates of the first objective documentation of radiographic progressive disease (PD) or death due to any cause.
5 secondary outcomes
Overall Survival (OS)
Time frame: Within approximately 48 months
Objective Response Rate (ORR)
Time frame: Within approximately 48 months
Duration of Response (DOR)
Time frame: Within approximately 48 months
Disease Control Rate (DCR)
Time frame: Within approximately 48 months
Incidence of Treatment-related Adverse Events
Time frame: Within approximately 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yanxia Shi principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Organoid-guided personalized treatment, Gemcitabine and Capecitabine in people with Breast Cancer and Refractory Breast Carcinoma, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanxia Shi (020-87343368, shiyx@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Within approximately 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.