QL1706 plus short-cycle anthracycline or taxane chemotherapy for early-stage triple-negative breast cancer

A Prospective, Single-Center, Exploratory Study of QL1706 Combined With Short-Cycle Anthracyclines or Taxanes for the Treatment of Early-Stage Triple-Negative Breast Cancer

This trial will test whether adding QL1706, a dual PD-1/CTLA-4 antibody, to short-cycle anthracycline- or taxane-based chemotherapy helps patients with newly diagnosed early-stage triple-negative breast cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Xijing Hospital (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, Avellutolimab, cyclophosphamide
• Locations: 1 site (Xi'an, Shaanxi)
• Trial ID: NCT07178171 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, open-label trial combining QL1706 (a bispecific anti–PD-1/anti–CTLA-4 antibody) with short-cycle chemotherapy regimens such as pirarubicin, nab-paclitaxel, carboplatin (AUC 5), and cyclophosphamide in adults with newly diagnosed, unilateral, measurable TNBC (clinical stage cT2–T4, cN0–cN3). Participants must be chemotherapy- and immunotherapy-naïve and have ECOG 0–1 and adequate organ function. The protocol administers combination therapy and monitors safety, tolerability, and preliminary tumor response using RECIST 1.1 criteria. Treatment-related adverse events, dose-limiting toxicities, and early signs of anti-tumor activity will guide dose decisions and further development.

Who should consider this trial

Good fit: Women aged 18–70 with newly diagnosed, unilateral, measurable early-stage (cT2–T4, cN0–cN3) triple-negative breast cancer, ECOG 0–1, adequate organ function, no prior systemic therapy, and agreement to required contraception are the intended participants.

Not a fit: Patients with metastatic disease, prior chemotherapy or immunotherapy for invasive breast cancer, bilateral tumors, inadequate organ function, or who cannot comply with contraception or study visits are unlikely to qualify or benefit from this trial.

Why it matters

Potential benefit: If successful, the combination could strengthen anti-tumor immunity and increase tumor shrinkage or pathologic complete response rates beyond chemotherapy alone.

How similar studies have performed: Other immune checkpoint inhibitors combined with chemotherapy have shown benefit in TNBC and QL1706 monotherapy showed activity in advanced cervical cancer, but using this specific bispecific PD-1/CTLA-4 agent in early-stage TNBC is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Female patients aged ≥18 and ≤70 years with newly diagnosed invasive breast cancer.
2. Triple-negative breast cancer (TNBC) with clinical stage cT2-T4 and cN0-cN3.
3. Unilateral disease.
4. No prior chemotherapy or immunotherapy for invasive breast cancer.
5. ECOG performance status of 0-1.
6. Adequate renal, hepatic, cardiovascular, and bone marrow function.
7. The patient voluntarily participates and signs the informed consent form.
8. According to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, patients should have measurable tumor lesion.
9. Estimated life expectancy ≥6 months
10. Female subjects enrolled must be surgically sterilized, postmenopausal, or agree to use at least one medically acceptable method of contraception (e.g., intrauterine device \[IUD\], oral contraceptives, or condoms) during study treatment and for 6 months after the end of study treatment. The serum or urine pregnancy test within 7 days prior to enrollment must be negative, and the subject must not be breastfeeding.
11. Able to comply with study and follow-up procedures and willing to adhere to the visit schedule and the prohibitions and restrictions specified in the protocol.

Exclusion Criteria:

1. History of invasive malignant tumor within ≤5 years prior to signing the informed consent form, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.
2. History of autoimmune disease;
3. Active hepatitis B or C virus infection, except for hepatitis B virus carriers or patients stabilized after antiviral therapy, who may be enrolled if HBV DNA titer is ≤500 IU/mL or \<2500 copies/mL. Active hepatitis C is defined as known HCV antibody positivity with a known HCV RNA quantitative result above the lower limit of detection of the assay.
4. Presence of any active infection requiring systemic therapy.
5. Currently using corticosteroids or immunosuppressive agents.
6. Prior treatment with immune checkpoint inhibitors.
7. Presence of psychiatric disorders or other conditions that may affect patient compliance.
8. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
9. Pregnant or breastfeeding female patients.
10. Known allergy to the investigational drugs used in this study or their components.
11. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this clinical trial.

Where this trial is running

Xi'an, Shaanxi

• Xijing hospital — Xi'an, Shaanxi, China (Recruiting)

Study contacts

• Study coordinator: Zhe Dr. Wang

Conditions TNBC, Triple Negative Breast Cancer