A Prospective, Multigroup, Multi-center, Open-label Clinical Study of Trastuzumab Rezetecan as Neoadjuvant Therapy Combined With Toripalimab in HR+/HER2-low Breast Cancer Patients (NEOTORCH-BREAST 08)
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
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).
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Female patients aged 18-70 years old;
• ECOG score is 0-1 points;
• Histologically or pathologically confirmed invasive breast cancer, meeting the following criteria simultaneously: Invasive breast cancer staged as T1cN1-2M0 or T2-3N0-2M0; All patients must be pathohistologically confirmed as HR-positive/HER2-low. The interpretation of ER and PR status follows the 2020 ASCO/CAP Guidelines: expression ≥1% is defined as positive, and HR positivity is confirmed if either ER or PR is positive. The interpretation of HER2 status follows the 2023 ASCO/CAP Guidelines: HER2-low is defined as HER2 1+ or 2+ with negative FISH test results. Pathological testing for PD-L1 expression: The Combined Positive Score (CPS) is the percentage of PD-L1-positive cells (including tumor cells, lymphocytes, and macrophages) among the total number of tumor cells. The PD-L1 antibody clone used for detection at our center is 22C3. No prior anti-cancer treatment.
• Function levels of major organs must meet the required criteria
• For female patients who have not yet reached menopause or undergone surgical sterilization: during the treatment period and in the study treatment, the final use effective contraceptive methods for at least 6 months after a single administration.
• Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.
Locations
Other Locations
China
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
The First Affiliated Hospital of Anhui Medical University
RECRUITING
Hefei
Zhongshan Hospital, Fudan University
RECRUITING
Shanghai
The Second Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
The Second Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Zhengzhou
Contact Information
Primary
Zhijun Dai
dzj0911@126.com
+86 157 0581 9132
Backup
Wanting Shao
shaowt111@163.com
+86 13777556621
Time Frame
Start Date:2026-02-01
Estimated Completion Date:2031-02-01
Participants
Target number of participants:111
Treatments
Experimental: Neoadjuvant therapy combined with Trastuzumab Rezetecan and Toripalimab
Drug: Neoadjuvant therapy combined with Trastuzumab Rezetecan and Toripalimab Description:Trastuzumab Rezetecan administered intravenously at a dose of 4.8mg/kg every 3 weeks for a total of 24 weeks with Toripalimab intravenous infusion of 240mg. During postoperative adjuvant therapy, Toripalimab used as before till a total of 1 year.
Drug: Neoadjuvant Chemotherapy in Combination with Toripalimab Description: Epirubicin (or Liposomal Doxorubicin)+Cyclophosphamide, intravenous infusion of 100 mg/m2. Epirubicin (or 35 mg/m2 liposomal doxorubicin)+600 mg/m2 cyclophosphamide, starting from the first day of the week, for a total of 12 weeks. Paclitaxel, administered intravenously at a dose of 260 mg/m2 every 3 weeks for a total of 12 weeks. During neoadjuvant chemotherapy and postoperative adjuvant therapy, use of Toripalimab: intravenous infusion of 240 mg, once every 3 weeks, combined with preoperative neoadjuvant and postoperative adjuvant therapy for a total of 1 year.
Other: Neoadjuvant Chemotherapy
Drug: Neoadjuvant Chemotherapy Description: Epirubicin (or Liposomal Doxorubicin)+Cyclophosphamide, intravenous infusion of 100 mg/m2. Epirubicin (or 35 mg/m2 liposomal doxorubicin)+600 mg/m2 cyclophosphamide, starting from the first day of the week, for a total of 12 weeks. Paclitaxel, administered intravenously at a dose of 260 mg/m2 every 3 weeks for a total of 12 weeks.