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

Recruiting

• Conditions: HER2-positive Breast Cancer

• Registration Number: NCT06722612
• Lead Sponsor: Shu Wang

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-04
• Study First Submitted QC: 2024-12-04
• Last Update Submitted: 2024-12-04
• Study First Posted: 2024-12-09
• Last Update Posted: 2024-12-09
• Primary Completion: 2031-12-31
• Study Completion: 2031-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 2916

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
disease free survival	5 years	The time from study enrollment to the first occurrence of the following events defined as failure, including ipsilateral local recurrence, contralateral breast cancer, distant recurrence or death from any cause.

Secondary Outcome Measures

Name	Time	Method
breast cancer specific survival	5 years	Time from study enrollment to death due to breast cancer
overall survival	5 years	Time from study enrollment to death from any cause
distant disease free survival	5 years	Time from study enrollment to distant recurrence and metastasis
invasive disease free survival	5 years	The time from study enrollment to the first occurrence of the following events defined as failure: local recurrence of ipsilateral invasive breast cancer, contralateral invasive breast cancer, distant recurrence or death from any cause.

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China