Choosing adjuvant therapy for HER2 positive early breast cancer after initial treatment

A Cohort Study of Different Choice of Adjuvant Therapy in Non-PCR Patients With HER2 Positive Early Breast Cancer After Neoadjuvant Therapy

This study is testing whether a combination of trastuzumab and pertuzumab works better than T-DM1 for people with HER2 positive breast cancer who still have cancer after their initial treatment.

Quick facts

• Study type: Observational
• Enrollment: 2092 (estimated)
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Drugs / interventions: trastuzumab, pertuzumab, chemotherapy, patuzumab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06693037 on ClinicalTrials.gov

What this trial studies

This study focuses on patients with HER2 positive breast cancer who have undergone neoadjuvant therapy with trastuzumab and pertuzumab but still have residual invasive cancer post-surgery. It aims to evaluate the effectiveness of different adjuvant therapies, specifically comparing a combination of trastuzumab and pertuzumab versus T-DM1. The study will retrospectively recruit patients treated between January 2019 and November 2024 and prospectively recruit from December 2024 to December 2028. The goal is to improve prognosis and survival rates for this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with HER2 positive breast cancer who have undergone neoadjuvant therapy and have residual invasive cancer post-surgery.

Not a fit: Patients with metastatic breast cancer, bilateral breast cancer, or those who did not undergo radical surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective adjuvant therapy options for patients with residual HER2 positive breast cancer, potentially improving their survival rates.

How similar studies have performed: Previous studies have shown varying success with adjuvant therapies for HER2 positive breast cancer, but this specific approach is novel and aims to address gaps in current treatment guidelines.

Eligibility criteria

Inclusion Criteria:

* 1\) Patients with HER2 positive breast cancer were diagnosed by biopsy in Peking University People's hospital;
* 2\) The clinical stages before treatment were T1-T4, N0-N3, M0;
* 3\) Received treatment and operation in our hospital, and had hospitalization records;
* 4\) Receive at least 4 cycles of trastuzumab and pertuzumab target therapy combined chemotherapy as neoadjuvant therapy
* 5\) Postoperative pathology confirmed the presence of residual invasive breast cancer in the breast and/or metastatic tumor lesions in axillary lymph nodes;
* 6\) 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\) Patients with metastatic breast cancer or bilateral breast cancer;
* 3\) Failure to perform radical surgery;
* 4\) Receiving other regimens besides the established neoadjuvant regimens.

Where this trial is running

Beijing, Beijing Municipality

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

Study contacts

• Principal investigator: shu wang, doctor — Peking University People's Hospital
• Study coordinator: yuan peng, doctor

Conditions HER2-positive Breast Cancer; neoadjuvant chemotherapy; non-pCR; T-DM1