Status:
RECRUITING
Efficacy and Safety of Paclitaxel Polymeric Micelles for Injection in the Treatment of Metastatic Breast Cancer
Lead Sponsor:
Shanghai Yizhong Pharmaceutical Co., Ltd.
Conditions:
Metastatic Breast Cancer (MBC)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 fai...
Eligibility Criteria
Inclusion
- Eligible subjects 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 standard immunohistochemical (IHC) test result of 0 or 1+; Or the IHC test result is 2+ and the ISH test result is negative including FISH/CISH/SISH)；
- Archival slides or newly obtained biopsy slides from metastatic or recurrent sites are available (Note: Bone lesion biopsy is not accepted);
- Subjects who are refractory or relapsed after ≥2 and ≤4 prior systemic chemotherapy regimens or antibody-drug conjugates (ADC) for MBC are eligible(Subjects were eligible for inclusion if their previous chemotherapy regimen included taxanes or not; Subjects using taxanes for adjuvant or neoadjuvant chemotherapy more than 6 months after the treatment, and Subjects using taxanes for advanced-stage treatment more than 3 months after the treatment, with recurrence or metastasis are eligible.) Adjuvant or neoadjuvant chemotherapy for early-stage disease can be considered as one of the required prior chemotherapy regimens if unresectable, locally advanced, or metastatic disease develops within 12 months after completion of the regimen.( Note: Therapies for bone metastases (e.g., bisphosphonates, denosumab, etc.) are not considered prior systemic chemotherapy for advanced disease.)；
- Subjects are eligible to receive one the chemotherapy regimens in the TPC group；
- According to RECIST 1.1, subjects 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); Subjects with unmeasurable skeletal lesions only are not accepted；
- 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 routine test)：
- : White blood cell count ≥3.0x109/L; Neutrophil count ≥1.5x109/L；
- : Platelet count ≥100×109/L;
- ：Hemoglobin≥90g/L;
- : If subjects 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 continuing screening.
- 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 subjects with liver metastases, and ALP≤10×ULN for subjects with bone metastases);
- : Creatinine clearance (calculated using Cockcroft-Gault formula) ≥50 ml/min.
- Subjects have no symptoms of cardiac dysfunction (NYHA class ≤II) at baseline and no significant or clinically insignificant ECG abnormalities;
- Subjects 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 who voluntarily used effective contraception; Women of childbearing age who have a negative blood/urine pregnancy test within 7 days prior to enrollment.
Exclusion
- Subjects 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 subjects; Subjects with intracranial hypertension or neuropsychiatric symptoms after treatment of central nervous system tumors;
- Subjects with acute or chronic infections that have not been eliminated, or subjects with other serious diseases at the same time;
- Subjects have other malignant tumors within 5 years (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix);
- Subjects 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;
- Subjects 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 enrollment;
- Subjects with active hepatitis, or liver metastasis is more than 3/4 of the whole liver;
- Subjects 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; Subjects with a small amount of pleural effusion without clinical symptoms and no need for clinical intervention should be strictly controlled before enrollment;
- Subjects with mental illness or disorder, poor compliance, or inability to cooperate, or describe treatment responses;
- Subjects who cannot tolerate chemotherapy due to severe organic disease or major organ failure, such as decompensated heart and lung failure;
- Subjects with bleeding disorders;
- Subjects with organ transplant;
- Subjects with bad drug addicts, long-term alcoholics, infectious diseases such as AIDS;
- Subjects on long-term use of adrenocortical hormones or immunosuppressants;
- Subjects 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 weeks before enrollment, or are scheduled to receive vaccines during the study period; Subjects who received all types of COVID-19 vaccines within two weeks before enrollment;
- Subjects 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 enrollment or who still have grade ≥2 toxicity from previous antineoplastic therapy (except alopecia and grade ≤2 neurotoxicity caused by platinum) at enrollment;
- Subjects 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 (testing is not necessary if there is no clinical evidence to suggest possible HIV infection);
- Subjects are considered not able to complete the trial or otherwise unfit to participate in the study by the investigators.
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT06143553
Start Date
September 25 2023
End Date
December 1 2025
Last Update
November 29 2024
Active Locations (3)
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1
Jiangsu province Hospital
Nanjing, Jiangsu, China, 210029
2
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 201321
3
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 201321