RecruitingNCT06711068

Adjuvant Therapy for Intermediate Risk HER2 Positive, Lymph Node Negative Early Breast Cancer With Chemotherapy Combined Target Therapy

Cohort Study of Adjuvant Chemotherapy Combined With Targeted Therapy for Intermediate Risk HER2 Positive and Lymph Node Negative Early Breast Cancer


Sponsor

Shu Wang

Enrollment

8,077 participants

Start Date

Jan 1, 2019

Study Type

OBSERVATIONAL

Conditions

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 trastuzumab and pertuzumab 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. 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

Inclusion Criteria3

  • \) Treatment in Peking University People's Hospital for radical resection of breast cancer and had hospitalization records;
  • \) Postoperative pathology confirmed invasive breast cancer, and the pathological stage was T1c, N0, HER2 positive, with other high-risk factors (G3, or hormone receptor negative); Or the pathological stage is T2, N0, and there are no high-risk factors (G3, or hormone receptor negative);
  • )Signed an agreement to participate in the PKUPH Breast Disease Cohort study at Peking University People's Hospital.

Exclusion Criteria4

  • \) Lack of clinical pathological data (such as imaging data, pathological data);
  • \) Preoperative neoadjuvant therapy;
  • \) Patients with metastatic breast cancer or bilateral breast cancer;
  • \) Failed to undergo curative surgery.

Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT06711068


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