OncoMatch/Clinical Trials/NCT07383818
Neoadjuvant Therapy Combined With Trastuzumab Rezetecan and Toripalimab for HR+/HER2-low Breast Cancer (NEOTORCH-BREAST 08)
Is NCT07383818 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Neoadjuvant therapy combined with Trastuzumab Rezetecan and Toripalimab and Neoadjuvant Chemotherapy in Combination with Toripalimab for hr positive/her2 low breast cancer.
Treatment: Neoadjuvant therapy combined with Trastuzumab Rezetecan and Toripalimab · Neoadjuvant Chemotherapy in Combination with Toripalimab · Neoadjuvant Chemotherapy — This study is a prospective, multi-cohort, multicenter, open-label exploratory clinical trial. The primary study objective is to evaluate the pathologic complete response (PCR) of treatment of HR+/HER2-low breast cancer with neoadjuvant therapy combined with Trastuzumab Rezetecan and Toripalimab , including the incidences and types of adverse events. The secondary endpoints include event-free survival (EFS), residual cancer burden (RCB), and objective response rate (ORR).
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (ER ≥1% (ASCO/CAP 2020))
expression ≥1% is defined as positive, and HR positivity is confirmed if either ER or PR is positive
Required: PR (PGR) overexpression (PR ≥1% (ASCO/CAP 2020))
expression ≥1% is defined as positive, and HR positivity is confirmed if either ER or PR is positive
Required: HER2 (ERBB2) low expression (IHC 1+ or 2+ with negative FISH) (HER2 1+ or 2+ with negative FISH (ASCO/CAP 2023))
HER2-low is defined as HER2 1+ or 2+ with negative FISH test results
Required: PD-L1 (CD274) expression (PD-L1 CPS (22C3 antibody clone); no threshold specified)
Pathological testing for PD-L1 expression: The Combined Positive Score (CPS)... The PD-L1 antibody clone used for detection at our center is 22C3
Disease stage
Required: Stage T1CN1-2M0, T2-3N0-2M0
Excluded: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-tumor treatment
No prior anti-cancer treatment
Cannot have received: radiation therapy
Exception: excluding those that have been cured Malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma
Previously received anti-tumor treatment or radiation therapy for any malignant tumor, excluding those that have been cured Malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma
Lab requirements
Blood counts
Kidney function
Liver function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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