QL1706 with chemotherapy before surgery for triple-negative breast cancer

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

This treatment tests whether giving QL1706 together with two sequential chemotherapy regimens before surgery helps people with stage II–III triple-negative breast cancer achieve a complete tumor response.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Affiliated Hospital of Nantong University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, cyclophosphamide, doxorubicin
• Locations: 1 site (Nantong, Jiangsu)
• Trial ID: NCT07342283 on ClinicalTrials.gov

What this trial studies

This is a single-center, single-arm, prospective Phase 2 study enrolling 30 patients with newly diagnosed stage II–III triple-negative breast cancer. Participants receive four 21-day cycles of QL1706 combined with carboplatin and albumin-bound paclitaxel, followed by four 21-day cycles of QL1706 combined with doxorubicin or epirubicin plus cyclophosphamide. The main outcome measured is the pathological complete response (pCR) rate at the time of surgery, and patients are followed for one year after treatment. Eligible patients are treatment-naïve adults with ER-/HER2- tumors that are at least 2 cm or have confirmed/clinically palpable lymph node involvement.

Who should consider this trial

Good fit: Ideal candidates are adults (≥18) with newly diagnosed, treatment‑naïve stage II–III triple‑negative breast cancer, ECOG 0–1, adequate organ function, and tumors ≥2 cm or node-positive disease who are eligible for neoadjuvant chemotherapy and planned for surgery.

Not a fit: Patients with metastatic disease, hormone receptor–positive or HER2‑positive tumors, prior systemic therapy for the current cancer, significant organ dysfunction, or pregnancy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could raise the rate of complete tumor eradication before surgery, which may improve long-term outcomes and reduce the need for extensive surgery.

How similar studies have performed: Similar approaches combining immune checkpoint inhibitors with neoadjuvant chemotherapy in triple‑negative breast cancer have shown improved pCR rates in other trials, though QL1706 itself represents a specific investigational agent.

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.

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Where this trial is running

Nantong, Jiangsu

• Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Liu Fan

Conditions Triple Negative Breast Cancer