OncoMatch/Clinical Trials/NCT06914440
Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer
Is NCT06914440 recruiting? Yes, currently enrolling (Sep 2026). This Phase 2 trial studies multiple treatments including Toripalimab and Neoadjuvant Chemotherapy for breast cancer.
Treatment: Toripalimab · Neoadjuvant Chemotherapy · Adjuvant Chemotherapy · Endocrine therapy — The goal of this clinical trial is to evaluate the efficacy and safety of neoadjuvant stereotactic body radiotherapy (SBRT) followed by nab-paclitaxel combined with toripalimab in patients with previously untreated HR+/HER2-negative breast cancer. Eligible patients include those with stage IIB-IIIC disease (cT3N0, cT2-4N1-3 or cT1N2-3) or stage IIA disease (cT2N0 or cT1N1) with at least two of the following high-risk factors: histologic grade 3, Ki-67 ≥50% or premenopausal with age \<50 years. A total of 27 enrolled patients will be assigned to receive the combination therapy. The primary question it aims to answer is whether this combination of radiotherapy, de-escalated chemotherapy, and immunotherapy can improve the total pathologic complete response (tpCR) rate (defined as ypT0/Tis ypN0).
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 expression (>1% staining by IHC)
ER-positive (>1% staining) and/or PR-positive (>1% staining) by IHC
Required: PR (PGR) expression (>1% staining by IHC)
ER-positive (>1% staining) and/or PR-positive (>1% staining) by IHC
Required: HER2 (ERBB2) wild-type (IHC 0/1+ or FISH ratio ≤1.8)
HER2-negative (IHC 0/1+ or HER2/neu FISH ratio ≤1.8)
Required: MKI67 expression (≥15%)
Ki-67 ≥15%
Disease stage
Required: Stage IIA, IIB, IIIA, IIIB, IIIC (other)
Grade: 2, 3
Clinical stage (per AJCC 8th edition) meeting one of the following: i. cT3N0, cT2-4N1-3, or cT1N2-3 (Stage IIB, IIIA, IIIB, or IIIC); ii. cT2N0 or cT1N1 (Stage IIA) with at least two of the following high-risk features: Histologic grade 3; Ki-67 ≥50%; Age <50 years and premenopausal status.
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Lab requirements
Blood counts
anc ≥1.5×10⁹/l; alc ≥0.5×10⁹/l; platelets ≥100×10⁹/l; hemoglobin ≥90 g/l; wbc ≥3.0×10⁹/l and ≤15×10⁹/l
Kidney function
bun/cr ≤1.5×uln; cr≥60 ml/min (cockcroft-gault formula)
Liver function
alt/ast ≤2.5×uln; alp ≤2.5×uln
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06914440 currently recruiting?
Yes, this trial is currently recruiting patients.
Does this trial require ESR1?
Yes, ESR1 expression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR expression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 wild-type is a required biomarker for enrollment.
What disease stage is eligible?
Stage IIA or IIB or IIIA or IIIB or IIIC is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
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