OncoMatch/Clinical Trials/NCT06914440
Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer
Is NCT06914440 recruiting? Yes, currently enrolling (Jun 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 radiotherapy followed by chemotherapy combined with immunotherapy in patients with previously untreated stage IIB-IIIC (cT3N0 or cT2-4N1-3) HR-positive and HER2-negative breast cancer. 27 enrolled patients will be assigned to receive stereotactic body radiotherapy followed by Nab-Paclitaxel combined with Toripalimab. The main question it aims th answer is that whether the combination therapy of radiotherapy, de-escalated chemotherapy, and immunotherapy could improve the pCR rate of HR-positive and HER2-negative breast cancer.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (>1% staining by IHC)
ER-positive (>1% staining) by IHC
Required: PR (PGR) overexpression (>1% staining by IHC)
PR-positive (>1% staining) by IHC
Required: HER2 (ERBB2) negative (IHC 0/1+ or HER2/neu FISH ratio ≤1.8) (IHC 0/1+ or FISH ratio ≤1.8)
HER2-negative (IHC 0/1+ or HER2/neu FISH ratio ≤1.8)
Required: MKI67 overexpression (≥15%)
Ki-67 ≥15%
Disease stage
Required: Stage IIB, IIIA, IIIB, IIIC
Grade: 23
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: antitumor therapy
Exception: within 1 month before enrollment
No prior antitumor therapy within 1 month before enrollment
Cannot have received: systemic targeted therapy
Exception: within 4 weeks before treatment
Prior systemic targeted therapy or immunostimulants (e.g., interferon, IL-2) within 4 weeks before treatment
Cannot have received: immunostimulant (interferon, IL-2)
Exception: within 4 weeks before treatment
Prior systemic targeted therapy or immunostimulants (e.g., interferon, IL-2) within 4 weeks before treatment
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.
Are there prior therapy exclusions?
Yes. Prior antitumor therapy, systemic targeted therapy, immunostimulant disqualifies patients from enrollment.
Does this trial require ESR1?
Yes, ESR1 overexpression is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR overexpression is a required biomarker for enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative (IHC 0/1+ or HER2/neu FISH ratio ≤1.8) is a required biomarker for enrollment.
What disease stage is eligible?
Stage 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