NCT06722612 Chemotherapy Combined With Targeted Therapy for High-risk HER2 Positive and Lymph Node Negative Early Breast Cancer
| NCT ID | NCT06722612 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Shu Wang |
| Condition | HER2-positive Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,916 participants |
| Start Date | 2019-01-01 |
| Primary Completion | 2031-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,916 participants in total. It began in 2019-01-01 with a primary completion date of 2031-12-31.
⚠ 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
Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and easy recurrence and metastasis. The emergence of HER2 targeted drugs has greatly improved the prognosis and survival of such patients. At present, for HER2 positive breast cancer patients with negative lymph nodes, chemotherapy drugs combined with trastuzumab is the current standard treatment scheme, and in most cases, chemotherapy uses a combination of two drugs, while the main beneficiaries of the target treatment of trastuzumab and pertuzumab are concentrated in the group of patients with positive lymph nodes. Can the use of target therapy to de-escalation chemotherapy and further achieve a strategy of high efficacy and low toxicity. It is planned to explore the efficacy and safety of T1-T2, HER2 positive early breast cancer patients with negative lymph nodes to achieve chemotherapy reduction based on risk stratification.
Eligibility Criteria
Inclusion Criteria: * 1\) Treated in Peking University People's Hospital and underwent radical resection with hospitalization records; * 2\) Postoperative pathology confirmed invasive breast cancer, pathological staging was T2, N0, HER2 positive, and accompanied by one of the high-risk factors (G3, or hormone receptor negative); * 3\) Has signed and agreed to participate in the PKUPH breast disease cohort study. Exclusion Criteria: * 1\) Lack of clinical and pathological data (such as imaging data and pathological data); * 2\) Preoperative neoadjuvant therapy; * 3\) Patients with metastatic breast cancer or bilateral breast cancer; * 4\) Failure to perform radical surgery.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06722612 clinical trial?
This trial is open to participants of all sexes, studying HER2-positive Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06722612 currently recruiting?
Yes, NCT06722612 is actively recruiting participants. Contact the research team at 13671287670@163.com for enrollment information.
Where is the NCT06722612 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06722612 clinical trial?
NCT06722612 is sponsored by Shu Wang. The trial plans to enroll 2,916 participants.
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