Evaluation of the Efficacy of Subcutaneous Trastuzumab-Pertuzumab Combination in Neoadjuvant Treatment of Non-Metastatic HER2-Positive Breast Cancer in Algerian Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Pathological Complete Response (pCR) Rate
研究概览
简要总结
This study aims to find out how effective and well-tolerated the subcutaneous form of trastuzumab-pertuzumab (known as Phesgo) is when given before surgery (neoadjuvant treatment) to Algerian women with early stage, HER2-positive breast cancer.
The study will take place in three oncology centers in Algeria (Blida, Aïn Defla, Médéa) and include around 70 adult women diagnosed with non-metastatic HER2-positive breast cancer. Participants will receive Phesgo along with standard chemotherapy over about 18 weeks, followed by surgery.
The main goal is to measure how many women achieve complete destruction of invasive cancer in the breast and nearby lymph nodes (pathological complete response, pCR). We will also look at other outcomes such as how many women can keep their breast, any side effects, quality of life, satisfaction with treatment, and factors that might predict response.
Results from this real-world study will help assess whether Phesgo can simplify treatment delivery, reduce hospital burden, and improve care access in Algeria where healthcare resources are often stretched.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participants aged 19 years or older.
- •Histologically confirmed HER2-positive breast cancer (by immunohistochemistry and/or in situ hybridization), non-metastatic.
- •Candidate for neoadjuvant therapy according to local clinical practice.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤
- •Left ventricular ejection fraction (LVEF) ≥ 50%.
- •Signed written informed consent.
排除标准
- •Evidence of distant metastases.
- •Prior anti-HER2 therapy.
- •Known contraindications to trastuzumab or pertuzumab.
- •Pregnancy or breastfeeding.
- •Disease progression during neoadjuvant treatment (if already started).
- •Refusal of surgery.
- •Withdrawal of consent.
结局指标
主要结局
Pathological Complete Response (pCR) Rate
时间窗: At the time of surgery, approximately 18-24 weeks after the start of neoadjuvant treatment.
The proportion of participants with no residual invasive cancer in the breast and axillary lymph nodes after completion of neoadjuvant therapy, defined as ypT0/Tis ypN0 according to standard pathological assessment. Pathological evaluation will be performed on surgical specimens by certified pathologists following local and international guidelines.
次要结局
- Breast-Conserving Surgery Rate(At the time of surgery, approximately 18-24 weeks after the start of neoadjuvant treatment.)
- Incidence of Adverse Events(From first dose of study treatment until 30 days after last dose (approximately 20-22 weeks).)
- Patient Satisfaction With Treatment(Post-surgery (approximately 24-28 weeks after treatment initiation).)
- Predictive Factors of Response(From baseline to surgery (approximately 18-24 weeks after treatment initiation).)