Clinical trial Recruiting at 1 site Observational

Combining chemotherapy and targeted therapy for early HER2 positive breast cancer

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

Run by Peking University People's Hospital · NCT06722612 · Data updated 2026-11-12

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.

More HER2-positive Breast Cancer trials

Quick facts

Study typeObservational
SexAll
Enrollment2916 (estimated)
SponsorPeking University People's Hospital
Academic / other
Drugs / interventionstrastuzumab, pertuzumab, chemotherapy
Locations1 site (Beijing, Beijing Municipality)
StatusRecruiting
StartedJanuary 1, 2019
Main results expectedDecember 31, 2031
Study endsDecember 31, 2031
Registry record updatedDecember 9, 2024
Trial IDNCT06722612 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.