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Clinical Trials in China / NCT07342283
Recruiting Phase 2

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

NCT07342283 · tracked via the Priya Life Science China tracker
Sponsor
Affiliated Hospital of Nantong University
Phase
Phase 2
Started
2026-02-25
Last updated
2026-03-02

Condition(s) studied

Triple Negative Breast Cancer (TNBC)

Investigational drug(s) / intervention(s)

Immunotherapy combined with chemotherapy

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.

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. 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; 2. 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; 3. 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; 4. Treatment-naïve subjects; 5. Age ≥18 years, both genders eligible; 6. ECOG performance status 0-1; 7. Adequate bone marrow, cardiac, and organ function; 8. 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; 9. Ability to comprehend and provide written informed consent. Exclusion Criteria: 1. 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; 2. Subjects who have received chemotherapy, immunotherapy, targeted therapy, or radiotherapy within the past 12 months; 3. Stage IV metastatic breast cancer; 4. Administration of a vaccine within 30 days before the first dose of the study treatment; 5. Subjects with severe systemic diseases; 6. Subjects with active infections (including but not limited to HIV, hepatitis B or C, tuberculosis); 7. 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; 8. Lactating women should discontinue breastfeeding during the study; 9. Subjects with known allergies to the study drug or any of its excipients; 10. Any other condition deemed inappropriate for participation in the study by the investigator. \-

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Affiliated Hospital of Nantong University Nantong Jiangsu Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07342283 on ClinicalTrials.gov ↗ ← All trials in China