Combining taxane chemotherapy with targeted therapy for low-risk HER2 positive breast cancer

A Cohort Study of Adjuvant Therapy With Taxane Combined Targeted Therapy for Low-risk HER2 Positive and Lymph Node Negative Breast Cancer

This study is testing if combining a type of chemotherapy with a targeted therapy can safely treat patients with low-risk HER2 positive breast cancer and reduce the need for stronger treatments.

Quick facts

• Study type: Observational
• Enrollment: 285 (estimated)
• Sex: Female
• Sponsor: Peking University People's Hospital (Academic / other)
• Drugs / interventions: trastuzumab, paltuzumab, chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06711055 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness and safety of combining taxane chemotherapy with trastuzumab for patients with low-risk HER2 positive breast cancer who have negative lymph nodes. The goal is to determine if this combination can reduce the need for more aggressive chemotherapy while maintaining efficacy. The study focuses on patients who have undergone radical resection of breast cancer and have specific pathological characteristics. By exploring this approach, the study aims to provide a more efficient and less toxic treatment strategy for this patient population.

Who should consider this trial

Good fit: Ideal candidates are patients who have undergone radical resection for invasive HER2 positive breast cancer with specific pathological stages and characteristics.

Not a fit: Patients with metastatic breast cancer, bilateral breast cancer, or those who have not undergone curative surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved treatment outcomes with reduced toxicity for patients with low-risk HER2 positive breast cancer.

How similar studies have performed: While there have been studies on HER2 targeted therapies, this specific combination approach for low-risk 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 T1a-b (T ≤ 1cm), N0, HER2 positive, with high-risk factors (G3, or hormone receptor negative); Or the pathological stage is T1c (1cm \< T ≤ 2cm), N0, and there are no high-risk factors (G1/G2, hormone receptor positive);
* 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