Combining chemotherapy and targeted therapy for early HER2 positive breast cancer

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

This study is testing if combining chemotherapy with targeted therapy can help people with early HER2 positive breast cancer feel better while using less chemotherapy.

Quick facts

• Study type: Observational
• Enrollment: 2916 (estimated)
• Sex: All
• Sponsor: Peking University People's Hospital (other)
• Drugs / interventions: trastuzumab, pertuzumab, chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06722612 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness and safety of combining chemotherapy with targeted therapy for patients with high-risk HER2 positive early breast cancer who have negative lymph nodes. The aim is to explore whether reducing chemotherapy while incorporating targeted treatments can maintain efficacy and minimize toxicity. The study focuses on patients who have undergone radical resection and have specific pathological characteristics indicating high risk. By stratifying patients based on risk factors, the research seeks to optimize treatment strategies for this subgroup.

Who should consider this trial

Good fit: Ideal candidates are patients with T2, N0, HER2 positive early breast cancer who have undergone radical surgery and have high-risk pathological features.

Not a fit: Patients with metastatic breast cancer, bilateral breast cancer, or those who have not undergone radical surgery will 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 the approach of combining targeted therapy with chemotherapy is established, this specific strategy for high-risk, lymph node negative patients is novel and has not been extensively tested.

Eligibility criteria

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.

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, carboplatin