Chemotherapy Combined With Targeted Therapy for High-risk HER2 Positive and Lymph Node Negative Early Breast Cancer

NCT06722612 · tracked via the Priya Life Science China tracker

Sponsor

Shu Wang

Phase

Observational

Started

2019-01-01

Last updated

2024-12-09

Condition(s) studied

HER2-positive Breast Cancer

Study summary

Human epidermal growth factor receptor 2 (HER2) positive breast cancer is a molecular subtype with high malignancy and easy recurrence and metastasis. The emergence of HER2 targeted drugs has greatly improved the prognosis and survival of such patients. At present, for HER2 positive breast cancer patients with negative lymph nodes, chemotherapy drugs combined with trastuzumab is the current standard treatment scheme, and in most cases, chemotherapy uses a combination of two drugs, while the main beneficiaries of the target treatment of trastuzumab and pertuzumab are concentrated in the group of patients with positive lymph nodes. Can the use of target therapy to de-escalation chemotherapy and further achieve a strategy of high efficacy and low toxicity. It is planned to explore the efficacy and safety of T1-T2, HER2 positive early breast cancer patients with negative lymph nodes to achieve chemotherapy reduction based on risk stratification.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

disease free survival — 5 years
The time from study enrollment to the first occurrence of the following events defined as failure, including ipsilateral local recurrence, contralateral breast cancer, distant recurrence or death from any cause.

Trial sites (1)

Facility	City	Region	Status
Peking University People's Hospital	Beijing	Beijing Municipality	Recruiting

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De-escalation of Neoadjuvant Chemotherapy Regimens With Targeted Therapy Among HER2 Positive Patients Recruiting

Other trials for the same condition

RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Recruiting

A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer Recruiting

Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR+/HER2+ Breast Cancer Recruiting

A Study to Assess the Effectiveness of Trastuzumab Deruxtecan in Chinese Breast Cancer Patients (REFRESH) Recruiting

Taxane Combined Targeted Therapy for Low-risk HER2 Positive and Lymph Node Negative Breast Cancer Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06722612 on ClinicalTrials.gov ↗ ← All trials in China