Adjuvant Therapy for Intermediate Risk HER2 Positive, Lymph Node Negative Early Breast Cancer With Chemotherapy Combined Target Therapy (TaxDHER2)

Shu Wang

Status: Enrolling

Conditions: HER2-positive Breast Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06711068

PKUPH2024Z165

Details and patient eligibility

About

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.

Enrollment: 8,077 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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 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);
• 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.

Trial design

8,077 participants in 2 patient groups

Taxanes combined with cyclophosphamide chemotherapy

Description:

Taxanes (paclitaxel, liposomal paclitaxel, docetaxel, albumin paclitaxel), cyclophosphamide chemotherapy, combined with targeted therapy with trastuzumab, for a total of 4 cycles, followed by targeted therapy maintenance for 1 year

Taxanes chemotherapy

Description:

Taxanes (paclitaxel, liposomal paclitaxel, docetaxel, albumin paclitaxel) combined with trastuzumab and pertuzumab targeted therapy, for a total of 4 cycles, followed by targeted therapy maintenance for 1 year