Targeted therapy for early HER2-positive breast cancer with no lymph node involvement

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

This study is testing whether a new treatment approach that combines targeted therapy with less chemotherapy can help women with early HER2-positive breast cancer and no lymph node involvement feel better while reducing side effects.

Quick facts

• Study type: Observational
• Enrollment: 8077 (estimated)
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Drugs / interventions: trastuzumab, pertuzumab, chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06711068 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the efficacy and safety of reducing chemotherapy in patients with intermediate risk HER2-positive early breast cancer who have negative lymph nodes. The study focuses on patients who have undergone radical resection and have specific pathological characteristics. By exploring the potential of targeted therapy combined with chemotherapy, the research seeks to identify a treatment strategy that minimizes toxicity while maintaining effectiveness. The goal is to improve outcomes for patients who traditionally may not benefit from the standard treatment regimen.

Who should consider this trial

Good fit: Ideal candidates include patients with T1c or T2, N0 HER2-positive breast cancer who have undergone radical surgery and meet specific pathological criteria.

Not a fit: Patients with metastatic breast cancer, bilateral breast cancer, or those who have received preoperative neoadjuvant therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and less toxic treatment options for patients with early HER2-positive breast cancer.

How similar studies have performed: While targeted therapies have shown promise in other studies, this specific approach for lymph node negative patients is relatively novel and has not been extensively tested.

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 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.

Where this trial is running

Beijing, Beijing Municipality

• Peking University People's Hospital — Beijing, Beijing Municipality, China (Recruiting)

Study contacts

• Study coordinator: yuan peng, doctor

Conditions HER2-positive Breast Cancer; Taxane; target therapy