RecruitingNCT06722612

Chemotherapy Combined With Targeted Therapy for High-risk HER2 Positive and Lymph Node Negative Early Breast Cancer

Cohort Study of Chemotherapy Combined With Targeted Adjuvant Therapy for High-risk HER2 Positive and Lymph Node Negative Early Breast Cancer

Sponsor

Shu Wang

Enrollment

2,916 participants

Start Date

Jan 1, 2019

Study Type

OBSERVATIONAL

Conditions

HER2-positive Breast Cancer

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

Plain Language Summary

Simplified for easier understanding

This study is looking at real-world outcomes for patients with early-stage HER2-positive breast cancer that is considered high-risk — specifically tumors larger than 2 cm with no lymph node involvement — who received post-surgery chemotherapy combined with HER2-targeted therapy. Researchers want to know if the outcomes match what is expected from clinical trial data. **You may be eligible if...** - You were treated at Peking University People's Hospital and had surgery to fully remove the tumor - Your pathology confirmed invasive breast cancer, staged as T2, N0, HER2-positive with at least one high-risk factor (grade 3 tumor or hormone receptor-negative) - You signed consent to participate in the breast disease cohort study **You may NOT be eligible if...** - Your clinical or pathological records are incomplete - You received chemotherapy before surgery (neoadjuvant therapy) - You have metastatic breast cancer or cancer in both breasts - You did not have a full surgical removal of the tumor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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