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Recruiting NCT06711055

NCT06711055 Taxane Combined Targeted Therapy for Low-risk HER2 Positive and Lymph Node Negative Breast Cancer

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Clinical Trial Summary
NCT ID NCT06711055
Status Recruiting
Phase
Sponsor Shu Wang
Condition HER2-positive Breast Cancer
Study Type OBSERVATIONAL
Enrollment 285 participants
Start Date 2015-01-01
Primary Completion 2031-12-31

Trial Parameters

Condition HER2-positive Breast Cancer
Sponsor Shu Wang
Study Type OBSERVATIONAL
Phase N/A
Enrollment 285
Sex FEMALE
Min Age N/A
Max Age N/A
Start Date 2015-01-01
Completion 2031-12-31

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Brief Summary

Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and high risk of recurrence and metastasis. 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 trastuzumab and paltuzumab are concentrated in the group of patients with positive lymph nodes. Can targeted therapy be used to reduce the progression of chemotherapy and further achieve efficient and low toxicity strategies. To explore the efficacy and safety of adjuvant therapy of taxane chemotherapy combined with trastuzumab targeting therapy for low-risk HER2 positive and lymph node negative early breast cancer.

Eligibility Criteria

Inclusion Criteria: * 1\) Treatment in Peking University People's Hospital for radical resection of breast cancer and had hospitalization records; * 2\) Postoperative pathology confirmed invasive breast cancer, and the pathological stage was T1a-b (T ≤ 1cm), N0, HER2 positive, with high-risk factors (G3, or hormone receptor negative); Or the pathological stage is T1c (1cm \< T ≤ 2cm), N0, and there are no high-risk factors (G1/G2, hormone receptor positive); * 3)Signed an agreement to participate in the PKUPH Breast Disease Cohort study at Peking University People's Hospital. Exclusion Criteria: * 1\) Lack of clinical pathological data (such as imaging data, pathological data); * 2\) Preoperative neoadjuvant therapy; * 3\) Patients with metastatic breast cancer or bilateral breast cancer; * 4\) Failed to undergo curative surgery.

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