Neoadjuvant trastuzumab rezetecan plus toripalimab for HR‑positive, HER2‑low breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multi‑cohort, multicenter, open‑label Phase 2 trial of neoadjuvant trastuzumab rezetecan combined with toripalimab, with some cohorts receiving standard chemotherapy. The primary endpoint is pathologic complete response (pCR) and the trial will record the incidence and types of adverse events. Secondary endpoints include event‑free survival (EFS), residual cancer burden (RCB), and objective response rate (ORR). Eligible patients are adults with newly diagnosed, operable HR‑positive/HER2‑low breast cancer and no prior systemic anticancer therapy.

Why it matters

Who can join: the full rules

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:

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.

Where it's running

• Harbin Medical University Cancer Hospital
  Harbin, China Recruiting
• The First Affiliated Hospital of Anhui Medical University
  Hefei, China Recruiting
• Zhongshan Hospital, Fudan University
  Shanghai, China Recruiting
• The Second Affiliated Hospital of Xi'an Jiaotong University
  Xi'an, China Recruiting
• The Second Affiliated Hospital of Xi'an Jiaotong University
  Zhengzhou, China Recruiting

Study contacts

• Study coordinator: Zhijun Dai
• Email: dzj0911@126.com
• Phone: +86 157 0581 9132

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.