Reducing chemotherapy for HER2 positive breast cancer patients

De-escalation of Neoadjuvant Chemotherapy Regimens (Taxanes Plus Carboplatin Versus Taxanes Only) With Target Therapy Among HER2 Positive Patients

This study is testing if using less chemotherapy can still be effective for patients with HER2 positive breast cancer while reducing side effects.

Quick facts

• Study type: Observational
• Enrollment: 519 (estimated)
• Sex: All
• Sponsor: Peking University People's Hospital (Academic / other)
• Drugs / interventions: trastuzumab, pertuzumab, Chemotherapy
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06700369 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the feasibility of de-escalating neoadjuvant chemotherapy regimens in patients with HER2 positive breast cancer. It focuses on comparing the standard combination of chemotherapy with targeted therapy against a single-agent chemotherapy approach. The study will involve patients diagnosed with stage II or III HER2 positive breast cancer who have received treatment at Peking University People's Hospital. The goal is to determine if a less intensive chemotherapy regimen can be effective while minimizing side effects.

Who should consider this trial

Good fit: Ideal candidates are patients with stage II or III HER2 positive breast cancer who have been treated at Peking University People's Hospital.

Not a fit: Patients with metastatic 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 reduced side effects and improved quality of life for patients undergoing treatment for HER2 positive breast cancer.

How similar studies have performed: While the approach of de-escalating chemotherapy is being explored, this specific study's methodology is relatively novel and not extensively tested.

Eligibility criteria

Inclusion Criteria:

* 1\) Patients with HER2 positive breast cancer diagnosed by biopsy in Peking University People's Hospital;
* 2\) The clinical stage was stage II or stage III (i.e. T2 and above, and/or lymph node positive, without distant organ metastasis);
* 3\) Received treatment in our hospital and had hospitalization records;
* 4\) 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\) 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

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

Conditions HER2-positive Breast Cancer; neoadjuvant chemotherapy; De-escalation