Neoadjuvant SBRT Followed by Nab-Paclitaxel Combined With Toripalimab in HR+/HER2- Breast Cancer: A Single-arm, Prospective Clinical Trial

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Radiation, Procedure
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Female patients aged ≥18 and ≤75 years at the time of signing informed consent.

• ECOG PS status of 0-1.

• Breast cancer assessed as non-metastatic (M0), meeting all of the following:

‣ Clinical stage: Stage IIB, IIIA, IIIB, or IIIC

⁃ Required imaging assessments (within 28 days): Abdominal CT, ECT Bone scan, Chest CT and Brain MRI

• Histologically or pathologically confirmed invasive carcinoma of no special type, with all of the following:

‣ Grade 2 or 3 (confirmed by central laboratory);

⁃ ER-positive (\>1% staining) and/or PR-positive (\>1% staining) by IHC;

⁃ HER2-negative (IHC 0/1+ or HER2/neu FISH ratio ≤1.8);

⁃ Ki-67 ≥15%.

• Patient deemed eligible for radiotherapy after MDT evaluation.

• No prior antitumor therapy within 1 month before enrollment.

• Organ Function Requirements (within 7 days prior to enrollment):

‣ Complete blood count (no transfusion or hematopoietic growth factors within 7 days): 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;

⁃ Blood biochemistry (no transfusion/albumin within 7 days): ALT/AST ≤2.5×ULN; ALP ≤2.5×ULN;BUN/Cr ≤1.5×ULN; Cr≥60 mL/min (Cockcroft-Gault formula);

⁃ Coagulation: PT/APTT ≤1.5×ULN; INR ≤1.5×ULN (if no anticoagulant therapy);

⁃ Urinalysis: Urine protein \<2+; if ≥2+, 24-hour urine protein must be ≤1g;

⁃ Thyroid function:TSH ≤1×ULN; if abnormal, normal T3/T4 levels required for eligibility.

• Women of childbearing potential must:

‣ Have a negative serum pregnancy test within 7 days before treatment;

⁃ Use highly effective contraception during the study and for 180 days after the last dose.

• Voluntarily sign informed consent, demonstrate good compliance, and commit to follow-up.

Locations
Other Locations
China
Xijing Hospital Affiliated to Air Force Military Medical University
RECRUITING
Xi'an
Xijing Hospital Affiliated to Air Force Military Medical University
RECRUITING
Xi'an
Contact Information
Primary
JIAJUN DING
yuki_ding1996@163.com
15121089323
Time Frame
Start Date: 2025-06-05
Estimated Completion Date: 2030-12
Participants
Target number of participants: 27
Treatments
Experimental: Treatment
During the neoadjuvant treatment period, participants will undergo stereotactic radiotherapy and subsequently receive chemotherapy combined with immunotherapy.
Related Therapeutic Areas
Sponsors
Leads: Xijing Hospital

This content was sourced from clinicaltrials.gov

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