Neoadjuvant therapy for low-risk HER2-positive breast cancer patients

Four Cycles Taxane With Trastuzumab and Pertuzumab Neoadjuvant Therapy Among T1c HER2 Positive Patients

This study is testing a new treatment plan for people with low-risk HER2-positive breast cancer to see if combining certain chemotherapy drugs with targeted therapy can work just as well with less intense treatment.

Quick facts

• Study type: Observational
• Enrollment: 171 (estimated)
• Sex: All
• Sponsor: Peking University People's Hospital (other)
• Drugs / interventions: chemotherapy, trastuzumab, pertuzumab
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06722599 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of a neoadjuvant therapy regimen combining single-agent taxane chemotherapy with trastuzumab and pertuzumab in patients with low-risk HER2-positive breast cancer. It aims to assess the potential for reduced treatment intensity while maintaining efficacy and minimizing toxicity. The approach is based on a large cohort database from Peking University People's Hospital, focusing on patients diagnosed with early-stage HER2-positive breast cancer. The study will utilize an ambispective cohort design to gather and analyze data from these patients.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with T1c, N0, M0 HER2-positive breast cancer at Peking University People's Hospital.

Not a fit: Patients with metastatic breast cancer, bilateral breast cancer, or those receiving other anti-tumor therapies 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 HER2-positive breast cancer.

How similar studies have performed: While the combination of taxane with trastuzumab and pertuzumab is standard, the specific focus on low-risk patients with single-agent taxane is less explored, making this approach somewhat novel.

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 were T1c, N0, M0;
3. Received treatment in our hospital and had hospitalization records;
4. Has signed and agreed to participate in the PKUPH breast disease cohort study;
5. It is up to the clinician to decide whether to add anthracycline chemotherapy in the adjuvant treatment stage.

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. At the same time, they received anti-tumor therapy in other clinical trials, including endocrine therapy and targeted therapy;
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

• Study coordinator: yuan peng, doctor

Conditions: HER2-positive Breast Cancer, neoadjuvant chemotherapy, De-escalation