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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Xijing hospital
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Zhe Dr. Wang
• Email: wangzhe9263@163.com
• Phone: +862984775271

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.