QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer

Обзор

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.

Вмешательства

• Препарат Immunotherapy combined with chemotherapy
  Albumin-bound paclitaxel: 125 mg/m², day 1 and day 8, 21-day cycle; Carboplatin: AUC = 5, day 1 or AUC = 2-3, day 1 and day 8, 21-day cycle; QL1706: 5 mg/kg, day 1, 21-day cycle; Epirubicin: 90-100 mg/m², day 1, 21-day cycle; or Doxorubicin: 50 mg/m², day 1, 21-day cycle; Cyclophosphamide: 600 mg/m², day 1, 21-day cycle.

Первичные конечные точки

• Pathologic complete response (pCR) rates [Срок оценки: Up to approximately 9 months]

Вторичные конечные точки (4)

• Objective response rate（ORR） [Срок оценки: Up to approximately 27-30 weeks]
• 3y-EFS [Срок оценки: Up to approximately 3 years]
• Overall survival (OS) [Срок оценки: Up to approximately 8 years]
• Adverse events [Срок оценки: up to 18 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Affiliated Hospital of Nantong University — Nantong

Идентификаторы

NCT: NCT07342283 · 2025-K223-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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