QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Pathologic complete response (pCR) rates
研究概览
简要总结
This is a single-center, single-arm, prospective study enrolling 30 patients with stage II-III triple-negative breast cancer. The neoadjuvant regimen consists of QL1706 combined with carboplatin plus albumin-bound paclitaxel (21-day cycles for 4 cycles) followed by QL1706 combined with doxorubicin/epirubicin plus cyclophosphamide (21-day cycles for 4 cycles). The treatment observation period is 1 year, and the primary endpoint is the pathological complete response rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed newly diagnosed ER-/HER2- breast cancer. ER and PR with Allred score <3 or <1% positively stained cells in tumor infiltrating components. HER2 negativity defined as 0 or 1+ by FISH or IHC staining per NCCN guidelines;
- •Clinical stage II or III breast cancer eligible for neoadjuvant chemotherapy (per AJCC 8th edition: at least T2 any N M0, or any T if N+), with treatment goal of complete surgical resection following neoadjuvant therapy;
- •Tumor size ≥2 cm by clinical or imaging assessment per WHO criteria. Patients with histologically confirmed or clinically palpable lymph nodes are eligible regardless of tumor size;
- •Treatment-naïve subjects;
- •Age ≥18 years, both genders eligible;
- •ECOG performance status 0-1;
- •Adequate bone marrow, cardiac, and organ function;
- •Women of childbearing potential must have a negative pregnancy test (serum or urine HCG) within 30 days prior to study enrollment and must practice effective contraception during the study;
- •Ability to comprehend and provide written informed consent.
排除标准
- •History of invasive malignancies within 5 years prior to signing the informed consent form, except for adequately treated basal cell carcinoma, squamous cell skin cancer, or carcinoma in situ of the cervix;
- •Subjects who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months;
- •Stage IV metastatic breast cancer;
- •Administration of a vaccine within 30 days before the first dose of the study treatment;
- •Subjects with severe systemic diseases;
- •Subjects with active infections (including but not limited to HIV, hepatitis B or C, tuberculosis);
- •Severe cardiovascular diseases, such as: history of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass grafting within the past 6 months; or congestive heart failure (CHF) of New York Heart Association (NYHA) class II-IV, or history of CHF NYHA class III or IV;
- •Lactating women should discontinue breastfeeding during the study;
- •Subjects with known allergies to the study drug or any of its excipients;
- •Any other condition deemed inappropriate for participation in the study by the investigator.
结局指标
主要结局
Pathologic complete response (pCR) rates
时间窗: Up to approximately 9 months
pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current American Joint Committee on Cancer (AJCC) staging criteria assessed by the local pathologist at the time of definitive surgery.
次要结局
- Objective response rate（ORR）(Up to approximately 27-30 weeks)
- 3y-EFS(Up to approximately 3 years)
- Overall survival (OS)(Up to approximately 8 years)
- Adverse events(up to 18 months)