Evaluation of Serum Tumor Markers in Assessing the Efficacy of TP Chemotherapy Combined With Trastuzumab and Pertuzumab Dual Target Therapy in HER2-Positive Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This is a prospective, randomized study to compare the efficacy of TP (Taxane plus Carboplatin) chemotherapy combined with dual-HER2 blockade (trastuzumab and pertuzumab) versus TP chemotherapy plus single-HER2 blockade (trastuzumab) in patients with HER2-positive breast cancer. The study aims to evaluate treatment response and the clinical value of serum tumor markers (CEA, CA125, and CA153) in assessing therapeutic efficacy.
详细描述
Human epidermal growth factor receptor 2 (HER2)-positive breast cancer accounts for 15-20% of all breast cancers and is associated with a more aggressive disease course. Dual blockade of the HER2 pathway with trastuzumab and pertuzumab, in combination with chemotherapy, has become a standard of care. This study was designed to investigate the added benefit of pertuzumab to a regimen of TP chemotherapy and trastuzumab. Ninety-eight patients with HER2-positive breast cancer were randomized to receive either TP chemotherapy with trastuzumab and pertuzumab (Study Group) or TP chemotherapy with trastuzumab alone (Control Group). The primary objectives were to compare the overall response rate (ORR) and disease control rate (DCR) between the two arms. Secondary objectives included the evaluation of changes in serum tumor marker levels (CEA, CA125, CA153) before and after treatment, the predictive value of these markers for treatment efficacy, and the safety profile of the regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed HER2-positive breast cancer.
- •Presence of measurable lesions.
- •No evidence of distant metastases.
- •No prior surgery or chemotherapy.
- •Voluntarily signed the informed consent form.
排除标准
- •Incomplete neoadjuvant therapy.
- •Incomplete clinical medical records.
- •Presence of distant organ metastasis.
- •Known allergy to study drugs.
- •Expected survival of less than 3 months.
- •Significant liver or kidney dysfunction.
- •Presence of hematological or immune system diseases.
- •Unclear pathological results.
- •Concurrent other malignant tumors.
- •Pregnant or lactating patients.
研究组 & 干预措施
Experimental: Study Group (Dual-Target Therapy)
Patients received TP chemotherapy combined with trastuzumab and pertuzumab. Treatment was administered for 6 cycles, with each cycle lasting 21 days.
干预措施: TP Chemotherapy + Trastuzumab + Pertuzumab (Drug)
Active Comparator: Control Group (Single-Target Therapy)
Patients received TP chemotherapy combined with trastuzumab only. Treatment was administered for 6 cycles, with each cycle lasting 21 days.
干预措施: TP Chemotherapy + Trastuzumab (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: After completion of Cycle 6 (each cycle is 21 days)
The proportion of patients with a complete response (CR) or partial response (PR) according to iRECIST criteria.
Disease Control Rate (DCR)
时间窗: After completion of Cycle 6 (each cycle is 21 days)
The proportion of patients with a complete response (CR), partial response (PR), or stable disease (SD) according to iRECIST criteria.
次要结局
- Change in Serum Carcinoembryonic Antigen (CEA) level(Baseline and after completion of Cycle 6 (each cycle is 21 days))
- Change in Serum Carbohydrate Antigen 125 (CA125) level(Baseline and after completion of Cycle 6 (each cycle is 21 days))
- Change in Serum Carbohydrate Antigen 153 (CA153) level(Baseline and after completion of Cycle 6 (each cycle is 21 days))
- Incidence of Treatment-Related Adverse Events(Monitored throughout the treatment period, from Baseline up to the completion of Cycle 6 (each cycle is 21 days))
研究者
Nanlin Li
Principal investigator
Shaanxi Provincial Cancer Hospital