QL1706 for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer

Recruiting now · Phase 2

Conditions studied: Breast Cancer, HR+/HER2- Breast Cancer

In brief

The goal of this clinical trial is to learn if QL1706 is effective in early HR+/HER2- breast cancer. It will also learn about the safety of QL1706. The main questions it aims to answer are: Does QL1706 combined with neoadjuvant chemotherapy improve the pCR rate of early HR+/HER2- breast cancer? What adverse events do participants have when receiving QL1706? Participants will: Receive QL1706 plus chemotherapy or chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant QL1706 every 3 weeks for up to 6 months from the beginning of the treatment.

Key facts

Study ID

NCT06967103

Run by

Henan Cancer Hospital

People needed

238

Starts

2025-09-08

Expected to finish

2029-05-30

Last updated by the study team

2026-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects meeting all of the following criteria are eligible for inclusion in this study:
• Voluntarily participates in the study, signs the informed consent form, and demonstrates good compliance.
• Female, aged ≥18 years .
• Evaluated by the research center as eligible to tolerate and scheduled to undergo radical breast cancer surgery, with no prior systemic anti-tumor therapy for breast cancer.
• cT2 - T4d N0-N3, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
• Histologically and/or cytologically confirmed hormone receptor-positive (HR+) breast cancer (estrogen receptor [ER] or progesterone receptor [PR] nuclear staining >1%) with Ki67 ≥20%.
• HER2-negative breast cancer, defined as:
• Negative in situ hybridization (ISH) results; or
• Immunohistochemistry (IHC) status of 0, 1+, or 2+. If IHC is 2+, ISH (e.g., FISH, CISH, SISH) must be negative.
• Willing to provide fresh or archived tumor tissue samples.
• At least one measurable lesion per RECIST 1.1 criteria.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Adequate organ function, defined as:
• Hematology:
• Hemoglobin ≥90 g/L
• Absolute neutrophil count ≥1.5 × 10⁹/L
• Platelet count ≥100 × 10⁹/L.
• Biochemistry:
• ALT and AST ≤2.5 × ULN (≤5 × ULN if liver metastases present);
• Total bilirubin ≤1.5 × ULN;
• Serum creatinine ≤1.5 × ULN or creatinine clearance (CCr) ≥60 mL/min.
• Coagulation:
• Activated partial thromboplastin time (APTT) ≤1.5 × ULN;
• International normalized ratio (INR) ≤1.5 × ULN.
• Cardiac function:

You may not qualify if…

• Subjects meeting any of the following criteria will be excluded from this study:
• Known severe hypersensitivity to macromolecular protein preparations, QL1706, albumin-bound paclitaxel, epirubicin hydrochloride, or their excipients.
• Stage IV metastatic breast cancer or other conditions deemed ineligible for curative surgery after neoadjuvant therapy by the investigator.
• Inflammatory breast cancer or bilateral primary breast cancer (including invasive or in situ carcinoma).
• Major surgery or significant trauma within 28 days prior to the first dose.
• Administration of live attenuated vaccines within 28 days before the first dose or anticipated during the study.
• Systemic corticosteroids or immunosuppressive therapy within 14 days prior to the first dose or anticipated during the study.
• Active autoimmune disease requiring systemic treatment within 2 years prior to enrollment, or history of autoimmune disorders.
• Severe systemic infection within 28 days or active infection requiring intravenous/oral antibiotics within 14 days prior to the first dose.
• Prior organ or allogeneic bone marrow transplantation or awaiting transplantation.
• History or evidence of interstitial lung disease or active non-infectious pneumonitis.
• Bleeding tendency or high risk of hemorrhage.
• Thromboembolic events (e.g., cerebrovascular accident, pulmonary embolism) within 6 months prior to enrollment.
• Congenital or acquired immunodeficiency (e.g., HIV infection).
• Active hepatitis:
• Hepatitis B: HBsAg-positive with HBV DNA ≥2000 IU/mL;
• Hepatitis C: HCV antibody-positive with HCV RNA above the upper limit of normal.
• Poorly controlled cardiac conditions, including:
• NYHA Class II or higher heart failure or LVEF <50%;
• Unstable angina;
• Myocardial infarction within 1 year;
• QTc interval >470 ms (female) on resting ECG.
• Other malignancies within 5 years (excluding basal cell carcinoma or cervical carcinoma in situ).
• Use of investigational drugs within 4 weeks prior to the first dose.
• History or current diagnosis of neurological or psychiatric disorders (e.g., epilepsy, dementia).

Where it is running

• Henan cancer hospital — Zhengzhou, China (enrolling)

Full record on ClinicalTrials.gov

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