OncoMatch/Clinical Trials/NCT06967103
QL1706 for the Neoadjuvant Treatment of HR+/HER2- Breast Cancer
Is NCT06967103 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
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.
Frequently asked questions
Is NCT06967103 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ESR1?
Yes, ESR1 expression >1% nuclear staining is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression >1% nuclear staining is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative ISH or IHC 0, 1+, or 2+ (with negative ISH if 2+) is a required biomarker for enrollment.
What disease stage is eligible?
Stage T4C or T4D or CT1C WITH AXILLARY LYMPH NODE METASTASIS is required.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify