NCT07383818 Neoadjuvant Therapy Combined With Trastuzumab Rezetecan and Toripalimab for HR+/HER2-low Breast Cancer (NEOTORCH-BREAST 08)
| NCT ID | NCT07383818 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | First Affiliated Hospital of Zhejiang University |
| Condition | HR Positive/HER2 Low Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 111 participants |
| Start Date | 2026-02-01 |
| Primary Completion | 2028-02-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 111 participants in total. It began in 2026-02-01 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07383818 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying HR Positive/HER2 Low Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07383818 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07383818 currently recruiting?
Yes, NCT07383818 is actively recruiting participants. Contact the research team at dzj0911@126.com for enrollment information.
Where is the NCT07383818 trial being conducted?
This trial is being conducted at Harbin, China, Hefei, China, Shanghai, China, Xi'an, China and 1 additional location.
Who is sponsoring the NCT07383818 clinical trial?
NCT07383818 is sponsored by First Affiliated Hospital of Zhejiang University. The trial plans to enroll 111 participants.
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