Efficacy and Safety of Lobaplatin and Carboplatin as Neoadjuvant Therapy in HER-2 Positive Breast Cancer

Официальное название

A Phase Ⅲ Study to Evaluate Efficacy and Safety of Lobaplatin and Carboplatin as Neoadjuvant Therapy in Participants With HER-2 Positive Breast Cancer.

Обзор

The aim of this study was to evaluate the efficacy, safety and tolerability of lobaplatin versus carboplatin as neoadjuvant therapy for stage II / III HER-2 positive breast cancer. Arms and Interventions Control group : Docetaxeor albumin paclitaxel combined with carboplatin for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage. Experimental group : Docetaxel or albumin paclitaxel combined with lobaplatin for 6 cycles. Trastuzumab combined with pertuzumab : 6 cycles of treatment, according to the instructions recommended dosage.

Вмешательства

• Препарат lobaplatin
  30mg / m2 i.v. q3w
• Препарат carboplatin
  AUC 5-6 i.v. q3w
• Препарат Docetaxel or albumin paclitaxel
  Docetaxel ( 75 mg / m2 i.v. d1, q3w ) or albumin paclitaxel ( 260 mg / m2 i.v. d1, q3w )
• Препарат Trastuzumab
  6 cycles of treatment, according to the instructions recommended dosage.
• Препарат pertuzumab
  6 cycles of treatment, according to the instructions recommended dosage.

Первичные конечные точки

• Pathological Complete Response [Срок оценки: Up to approximately 27-30 weeks]
• Adverse events (AEs) [Срок оценки: Up to approximately 35 weeks]

Вторичные конечные точки (4)

• Event-Free Survival (EFS) in all participants [Срок оценки: Up to approximately 5 years]
• Objective Overall Response Rate (ORR) [Срок оценки: Up to approximately 25-30 weeks]
• Disease-free survival ( DFS ) [Срок оценки: Up to approximately 5 years]
• Distant Disease-Free Survival(DDFS) [Срок оценки: Up to approximately 5 years]

Критерии участия

Критерии включения

• Newly diagnosed breast cancer
• 18-70 Years, female;
• life expectancy is not less than 3 months
• Histologically confirmed HER2 positive ( human epidermal growth factor receptor 2 \[ HER2 \] positive, estrogen receptor \[ ER \] and progesterone receptor \[ PR \] negative or positive );
• Stage at presentation: T1c N1-2 or T2-4 N0-2;
• at least one measurable lesion according to RECIST 1.1;

Adequate function of major organs meets the following requirements:

• Neutrophils ≥ 1.5×10\^9/L
• Platelets ≥ 100×10\^9/L
• Hemoglobin ≥ 90g/L
• lymphocyte≥0.5×10\^9/L
• Total bilirubin≤ 1.5 × the upper limit of normal (ULN)
• ALT and AST ≤ 3 × ULN
• ALP≤ 2.5 × ULN
• BUN and Cr ≤ 1.5 × ULN
• TSH≤ ULN
• Left ventricular ejection fraction (LVEF) ≥ 50%
• QTcF ≤ 470 ms
• Provides tumor tissue specimen to assess tumor programmed death-ligand 1 (PD-L1); .For women of childbearing potential: agreement to use contraceptive methods. Women who are not postmenopausal or have undergone a sterilization procedure must have a negative serum pregnancy test result within 72 hours prior to initiation of study drug.

Критерии исключения

• Stage Ⅳ (metastatic) breast cancer or bilateral breast cancer
• Inflammatory breast cancer
• patients who received chemotherapy, endocrine therapy, immunotherapy, biotherapy or TACE within 4 weeks before admission
• Has participated in an interventional clinical study with an investigational compound within 4 weeks prior to initiation of study treatment
• Prior treatment with anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4), anti-programmed death-1 (anti-PD-1), and anti-PD-L1 therapeutic antibodies .Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer.
• Major surgical procedure within 4 weeks prior to initiation of study treatment
• Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus
• Has a history of (non-infectious) pneumonitis, interstitial lung disease or uncontrollable systematicness diseases
• Administration of a live attenuated vaccine within 28 days prior to initiation of study treatment or anticipation of need for such a vaccine during the study .Has a known history of Human Immunodeficiency Virus (HIV).
• Has known active Hepatitis B, Hepatitis C or Autoimmune hepatitis
• Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
• Has active infection (CTCAE≥2) needed the treatment of antibiotic within 2 weeks prior to initiation of study treatment
• Has evidence of active tuberculosis within 1year prior to initiation of study treatment
• Prior allogeneic stem cell or solid organ transplantation
• Pre-existing motor or sensory neuropathy of a severity≥grade 2
• Has significant cardiovascular disease
• Treatment with systemic immunostimulatory agents within 4 weeks prior to initiation of study treatment
• Treatment with systemic immunosuppressive medications within 2 weeks prior to initiation of study treatment
• Has a known hypersensitivity to the components of the study treatment or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
• Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial .History of neurological or psychiatric disorders, including epilepsy or dementia.
• any other situation evaluated by researchers

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Breast Cancer Center Shandong Cancer Hospital and Institute Shandong First Medical Univers — Shandong

Идентификаторы

NCT: NCT07093931 · MA-BC-III-HER2+-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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