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RecruitingPhase 2NCT07342283

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

Sponsor

Affiliated Hospital of Nantong University

Enrollment

30 participants

Start Date

Feb 25, 2026

Study Type

INTERVENTIONAL

Summary

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

  • 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.

Exclusion Criteria11

  • 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.
  • \-

Interventions

DRUGImmunotherapy 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.

Locations(1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

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NCT07342283