Actively Recruiting
QL1706 for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer
Led by Henan Cancer Hospital · Updated on 2026-01-08
238
Participants Needed
1
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
QL1706 for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female aged 18 years or older
- Willing and able to voluntarily participate and comply with the study
- Eligible for and scheduled to have radical breast cancer surgery with no prior systemic anti-tumor therapy
- Clinical tumor stage cT2 to T4d N0 to N3, or cT1c with confirmed axillary lymph node metastasis
- Histologically or cytologically confirmed hormone receptor-positive breast cancer with Ki67 60 20%
- HER2-negative breast cancer confirmed by ISH or IHC testing
- Willing to provide fresh or archived tumor tissue samples
- At least one measurable lesion according to RECIST 1.1 criteria
- ECOG performance status of 0 or 1
- Adequate organ function including specified blood counts, liver, kidney, coagulation, and cardiac function
- Premenopausal or perimenopausal subjects agree to use effective contraception or abstain during treatment and for 90 days after last dose
You will not qualify if you...
- Known severe allergy to QL1706, albumin-bound paclitaxel, epirubicin, or related substances
- Stage IV metastatic breast cancer or ineligible for curative surgery after neoadjuvant therapy
- Inflammatory breast cancer or bilateral primary breast cancer
- Major surgery or significant trauma within 28 days before first treatment
- Use of live vaccines within 28 days before first treatment or planned during study
- Systemic corticosteroids or immunosuppressive therapy within 14 days before first treatment or planned during study
- Active autoimmune diseases requiring treatment within 2 years or history of autoimmune disorders
- Severe systemic infection within 28 days or infection requiring antibiotics within 14 days before first treatment
- Previous organ or bone marrow transplantation or awaiting transplantation
- History or signs of interstitial lung disease or active pneumonitis
- Bleeding disorders or high risk of bleeding
- Thromboembolic events within 6 months before enrollment
- Immunodeficiency such as HIV infection
- Active hepatitis B or C infection with specified viral loads
- Poorly controlled heart conditions including heart failure, recent heart attack, unstable angina, or prolonged QTc interval
- Other cancers within 5 years except certain skin or cervical cancers
- Use of investigational drugs within 4 weeks before first treatment
- History of neurological or psychiatric disorders like epilepsy or dementia
- History of pancreatitis
- Pregnancy, breastfeeding, or refusal to use contraception
- Any other condition deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Henan cancer hospital
Zhengzhou, China
Actively Recruiting
Research Team
Z
Zhenzhen Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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