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RecruitingNCT07383818Updated Feb 3, 2026

Neoadjuvant Therapy Combined With Trastuzumab Rezetecan and Toripalimab for HR+/HER2-low Breast Cancer (NEOTORCH-BREAST 08)

A Phase 2 interventional study of Neoadjuvant therapy combined with Trastuzumab Rezetecan and Toripalimab and Neoadjuvant Chemotherapy in Combination with Toripalimab in HR Positive/HER2 Low Breast Cancer, sponsored by First Affiliated Hospital of Zhejiang University. Recruiting at 5 sites in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-02-03.

Sponsored by First Affiliated Hospital of Zhejiang University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
111
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
Female
01

Study 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).

02

Conditions studied

  • HR Positive/HER2 Low Breast Cancer

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Keywords

  • Breast cancer
  • Toripalimab
  • Trastuzumab Rezetecan
  • Neoadjuvant therapy
  • HR Positive/HER2 Low Breast Cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 111 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

First Affiliated Hospital of Zhejiang University is the lead sponsor of 255 studies on the registry; 139 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Female patients aged 18-70 years old;
  2. ECOG score is 0-1 points;
  3. 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.
  4. Function levels of major organs must meet the required criteria
  5. 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.
  6. Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.

Exclusion criteria

Exclusion Criteria:

  1. Stage IV breast cancer.
  2. Inflammatory breast cancer.
  3. 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.
  4. Simultaneously undergoing anti-tumor treatment in other clinical trials, including but not limited to chemotherapy and endocrine therapy. Treatment, biological therapy, bone improvement drug therapy, or immune checkpoint inhibitor therapy, etc.
  5. The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before the first administration of the study drug, or the patient has not fully recovered from such surgical procedures.
  6. Serious heart disease or discomfort.
  7. Uncontrolled active infections that require treatment; History of immunodeficiency, including HIV testing positive Sexual, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.
  8. Patients with chronic active hepatitis B or active hepatitis C
  9. Have received immunotherapy and experienced adverse immune events such as immune related pneumonia and myocarditis, which have been determined by researchers to potentially affect the safety of the experimental medication.
  10. Individuals with a known history of allergies to the components of this medication regimen.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
111 participants (estimated)

Study arms

  • 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 therapy combined with Trastuzumab Rezetecan and Toripalimab

  • Experimental
    Neoadjuvant chemotherapy combined Toripalimab

    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.

    Drug: Neoadjuvant Chemotherapy in Combination with Toripalimab

  • 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.

    Drug: Neoadjuvant Chemotherapy

Interventions

  • DrugNeoadjuvant therapy combined with Trastuzumab Rezetecan and Toripalimab

    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.

  • DrugNeoadjuvant Chemotherapy in Combination with Toripalimab

    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.

  • DrugNeoadjuvant Chemotherapy

    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.

06

What researchers measure

Primary outcomes

  1. pathologic complete response（PCR）

    Time frame: 2 years

Secondary outcomes

  1. Event free survival (EFS)

    Time frame: 5 years

  2. objective response rate (ORR)

    Time frame: 5 years

  3. Residual Cancer Burden (RCB)

    Time frame: 2 years

07

Study locations

5 of 5 sites recruiting
  • Harbin Medical University Cancer Hospital
    Harbin, China
    • Tong Liu · Contact
    Recruiting
  • The First Affiliated Hospital of Anhui Medical University
    Hefei, China
    • Ying Chen · Contact
    Recruiting
  • Zhongshan Hospital, Fudan University
    Shanghai, China
    • Wei Zhu · Contact
    Recruiting
  • The Second Affiliated Hospital of Xi'an Jiaotong University
    Xi'an, China
    • Huafeng Kang · Contact
    Recruiting
  • The Second Affiliated Hospital of Xi'an Jiaotong University
    Zhengzhou, China
    • Pengwei Lv · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07383818
Lead sponsor
First Affiliated Hospital of Zhejiang University
Responsible party
Sponsor
First posted
Feb 3, 2026
Start date
Feb 1, 2026 (estimated)
Primary completion
Feb 1, 2028 (estimated)
Completion
Feb 1, 2031 (estimated)
Last update
Feb 3, 2026

Study contacts

Zhijun Dai
Contact
dzj0911@126.com
+86 157 0581 9132
Wanting Shao
Contact
shaowt111@163.com
+86 13777556621

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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