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Tests treatment safety and results for Metastatic Breast Cancer (MBC)
Official title Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT06143553
What this study is testing
What is Paclitaxel Polymeric Micelles for Injection?
Paclitaxel Polymeric Micelles for Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic breast cancer (mbc).
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 multicenter, randomized, open, parallel positive control study compares the clinical efficacy and safety of paclitaxel polymeric micelles for injection with TPC in HER2- MBC subjects who have failed ≥2 to≤4 previous chemotherapy regimens. Treatment Protocol: Subjects are randomized into paclitaxel polymeric micelles for injection group and the Physician's Choice (TPC) group by the proportion of 1:1.
- 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
- Eligible people must meet all the following criteria:
- Male or female 18 years and older;
- Understand the purpose, benefits and risks of this clinical trial, voluntarily participate in and sign the written informed consent;
- The Eastern Cooperative Oncology Group (ECOG)performance status is 0 or 1;
- Histologically or cytologically confirmed (local laboratory) HER2-metastatic breast cancer from recently acquired or newly acquired tumor biopsies...
You likely can't join if
- people meet the following criteria are not eligible for inclusion:
- Known allergy or intolerance to either study treatment or any excipients；
- Previous use of antibody-drug conjugate (ADC) with anti-microtubule inhibitor as payload drug are not eligible;
- Primary brain tumors or central nervous system metastases (including leptomeningeal metastases), except for single brain metastases strictly...
- people with acute or chronic infections that have not been eliminated, or people with other serious diseases at the same time;
- people have other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
See the full eligibility criteria
- Eligible people must meet all the following criteria:
- Male or female 18 years and older;
- Understand the purpose, benefits and risks of this clinical trial, voluntarily participate in and sign the written informed consent;
- The Eastern Cooperative Oncology Group (ECOG)performance status is 0 or 1;
- Histologically or cytologically confirmed (local laboratory) HER2-metastatic breast cancer from recently acquired or newly acquired tumor biopsies from locally-relapsed or metastatic sites (HER2- is defined as a...
- Archival slides or newly obtained biopsy slides from metastatic or recurrent sites are available (Note: Bone lesion biopsy is not accepted);
- people who are refractory or relapsed after ≥2 and ≤4 prior systemic chemotherapy regimens or antibody-drug conjugates (ADC) for MBC are eligible(people were eligible for inclusion if their previous chemotherapy regimen...
- people are eligible to receive one the chemotherapy regimens in the TPC group；
- According to RECIST 1.1, people with measurable lesions on contrast-enhanced CT or MRI (≥10mm in the major dimension on CT or MRI scan, and ≥15mm in the minor dimension of lymph nodes); people with unmeasurable skeletal...
- Functions of major organs such as heart, lung, liver and kidney are basically normal；
- Blood routine examination meets the following criteria (No blood transfusions, blood products, granulocyte colony-stimulating factor, or other hematopoietic growth factors were used within 7 days before the blood...
- : White blood cell count ≥3.0x109/L; Neutrophil count ≥1.5x109/L；
- : Platelet count ≥100×109/L;
- ：Hemoglobin≥90g/L;
- : If people receive blood component transfusion (red blood cells, platelets, etc.) during the screening period, blood routine test should be performed again at an interval of 1 week to meet the above criteria before...
- Blood biochemical examination must meet the following criteria:
- : Total bilirubin ≤1.5 times the upper limit of normal (ULN);
- : Aspartate Transaminase（AST）, Alanine Aminotransferase（ALT）, or Alkaline phosphatase（ALP）≤2.5 times ULN (ALT, AST, or ALP≤ 5×ULN for people with liver metastases, and ALP≤10×ULN for people with bone metastases);
- : Creatinine clearance (calculated using Cockcroft-Gault formula) ≥50 ml/min.
- people have no symptoms of cardiac dysfunction (NYHA class ≤II) at baseline and no significant or clinically insignificant ECG abnormalities;
- people have good compliance and voluntarily comply with the clinical trial protocol during the study, followed up by the investigators;
- All women of childbearing age, men of childbearing potential, or their spouses who have no plans to have children or donate sperm during the entire trial period and up to 6 months after the last dose of medication, or...
- people meet the following criteria are not eligible for inclusion:
- Known allergy or intolerance to either study treatment or any excipients；
- Previous use of antibody-drug conjugate (ADC) with anti-microtubule inhibitor as payload drug are not eligible;
- Primary brain tumors or central nervous system metastases (including leptomeningeal metastases), except for single brain metastases strictly controlled asymptomatic people; people with intracranial hypertension or...
- people with acute or chronic infections that have not been eliminated, or people with other serious diseases at the same time;
- people have other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- people with a known history of clinically significant active chronic obstructive pulmonary disease or other moderate to severe chronic respiratory disease within 6 months before enrollment;
- people with active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease), clinically significant gastrointestinal (GI) bleeding, intestinal obstruction, or GI perforation within 6 months before...
- people with active hepatitis, or liver metastasis is more than 3/4 of the whole liver;
- people with third-space effusions (e.g., moderate-to-massive pleural effusion, moderate-to-massive pericardial effusion, ascites) that cannot be controlled by drainage or other means; people with a small amount of...
- people with mental illness or disorder, poor compliance, or inability to cooperate, or describe treatment responses;
- people who cannot tolerate chemotherapy due to severe organic disease or major organ failure, such as decompensated heart and lung failure;
- people with bleeding disorders;
- people with organ transplant;
- people with bad drug addicts, long-term alcoholics, infectious diseases such as AIDS;
- people on long-term use of adrenocortical hormones or immunosuppressants;
- people who received vaccines (including live and live attenuated vaccines) such as measles, mumps, rubella, varicella, yellow fever, rabies, Bacille Calmette-Guérin vaccine（BCG ）and typhoid (oral) vaccines within 4...
- people who received antineoplastic drugs (including but not limited to chemotherapy, hormonal therapy, immunotherapy, antibody therapy, radiotherapy, surgery (except diagnostic biopsy), etc.) within 2 weeks before...
- people with active hepatitis B or C (previous history of hepatitis B infection, with or without drug control, HBV DNA≥1×104 copies or ≥2000 IU/mL; Hepatitis C infection, HCV RNA≥15IU/mL); Or HIV antibody positive...
- people are considered not able to complete the trial or otherwise unfit to participate in the study by the investigators.
The study team makes the final eligibility decision.
Where it's taking place
- Nanjing, Jiangsu, China
- Shanghai, Shanghai Municipality, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 - 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?
Study sites include Nanjing, Jiangsu, China; Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.