Trial comparing treatments for Breast Cancer
Official title Patient Derived Organoid-guided Personalized Treatment Versus Treatment of Physician's Choice in Breast Cancer
ClinicalTrials.gov ID: NCT06268652
What this study is testing
What is Gemcitabine?
Gemcitabine is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for breast cancer.
Also referred to as Gemzar.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase III trial is designed to study how well it works and how safe it is of organoid-guided personalized treatment （OGPT）versus treatment of physician's choice (TPC) in previously treated refractory breast cancer.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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;
You likely can't join if
- The patient is participating in other treatment clinical studies or the end of treatment in the previous clinical study is less than 4 weeks;（2）Those...
- Other active malignant tumors that require simultaneous treatment;
- Known history of organ transplantation and allogeneic hematopoietic stem cell transplantation;
- For people who have undergone major surgery or severe trauma, the effects of the surgery or trauma have been eliminated for less than 14 days before...
- Patients with active pulmonary tuberculosis need to be excluded. Patients suspected of having active pulmonary tuberculosis should have chest X-rays...
- Severe acute or chronic infection requiring systemic treatment
See the full eligibility criteria
- 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)
- 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;
- 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...
- The patient is participating in other treatment 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...
- Other active malignant tumors that require simultaneous treatment;
- Known history of organ transplantation and allogeneic hematopoietic stem cell transplantation;
- For people 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.
- 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...
- 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;
The study team makes the final eligibility decision.
Where it is enrolling
- Guangzhou, None Selected, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Guangzhou, None Selected, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.