NCT07342283 QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Triple-Negative Breast Cancer

Eligibility & Interventions

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 30 participants in total. It began in 2026-02-25 with a primary completion date of 2027-12-25.

Brief 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 Criteria

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. \-

Contact & Investigator

Frequently Asked Questions

Related Trials

Related Intelligence Guides

In-depth guides covering this condition's trials, eligibility, and what to expect.