OncoMatch/Clinical Trials/NCT06967103
QL1706 for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer
Is NCT06967103 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including QL1706 and Nab-PE for breast cancer.
Treatment: QL1706 · Nab-PE — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression >1% nuclear staining (>1% nuclear staining)
estrogen receptor [ER] or progesterone receptor [PR] nuclear staining >1%
Required: PR (PGR) expression >1% nuclear staining (>1% nuclear staining)
estrogen receptor [ER] or progesterone receptor [PR] nuclear staining >1%
Required: HER2 (ERBB2) negative ISH or IHC 0, 1+, or 2+ (with negative ISH if 2+) (IHC 0, 1+, or 2+ (with negative ISH if 2+))
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.
Required: MKI67 expression ≥20% (≥20%)
Ki67 ≥20%
Disease stage
Required: Stage T4C, T4D, CT1C WITH AXILLARY LYMPH NODE METASTASIS (clinical TNM)
Excluded: Stage IV
cT2 - T4d N0-N3, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；Stage IV metastatic breast cancer [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Lab requirements
Blood counts
hemoglobin ≥90 g/l; absolute neutrophil count ≥1.5 × 10⁹/l; platelet count ≥100 × 10⁹/l
Kidney function
serum creatinine ≤1.5 × uln or creatinine clearance (ccr) ≥60 ml/min
Liver function
alt and ast ≤2.5 × uln (≤5 × uln if liver metastases present); total bilirubin ≤1.5 × uln
Cardiac function
left ventricular ejection fraction (lvef) ≥50% by echocardiography
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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