Status:
RECRUITING
A Study of QL1706 Combined With Short-Cycle Anthracyclines or Taxanes for the Treatment of Early-Stage TNBC
Lead Sponsor:
Xijing Hospital
Collaborating Sponsors:
Qilu Pharmaceutical Co., Ltd.
Conditions:
TNBC, Triple Negative Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
Brief Summary
Triple-negative breast cancer (TNBC) accounts for about 20% of breast cancers, is poorly differentiated, progresses rapidly, and frequently recurs, making it the subtype with the worst prognosis. Owin...
Eligibility Criteria
Inclusion
- Female patients aged ≥18 and ≤70 years with newly diagnosed invasive breast cancer.
- Triple-negative breast cancer (TNBC) with clinical stage cT2-T4 and cN0-cN3.
- Unilateral disease.
- No prior chemotherapy or immunotherapy for invasive breast cancer.
- ECOG performance status of 0-1.
- Adequate renal, hepatic, cardiovascular, and bone marrow function.
- The patient voluntarily participates and signs the informed consent form.
- According to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, patients should have measurable tumor lesion.
- Estimated life expectancy ≥6 months
- 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.
- 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
- 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.
- History of autoimmune disease;
- 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.
- Presence of any active infection requiring systemic therapy.
- Currently using corticosteroids or immunosuppressive agents.
- Prior treatment with immune checkpoint inhibitors.
- Presence of psychiatric disorders or other conditions that may affect patient compliance.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Pregnant or breastfeeding female patients.
- Known allergy to the investigational drugs used in this study or their components.
- Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this clinical trial.
Key Trial Info
Start Date :
November 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2030
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07178171
Start Date
November 6 2025
End Date
August 1 2030
Last Update
November 24 2025
Active Locations (1)
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1
Xijing hospital
Xi'an, Shaanxi, China, 710032