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

NCT06722599 · 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

Neoadjuvant therapy in the treatment of breast cancer is not only a means of breast conserving surgery, but also a sensitive scheme for patients, in order to reduce the treatment grade, low toxicity and high efficiency. Chemotherapy combined with trastuzumab and pertuzumab is the standard neoadjuvant therapy for HER2 positive breast cancer patients. Paclitaxel plus carboplatin (TCb) is the first choice of chemotherapy recommended by major guidelines; As an alternative, single drug Taxus (T) is also listed as class I recommendation in the latest CSCO guidelines, but the level of evidence is slightly insufficient. In the HER2 positive neoadjuvant therapy population, relatively early and low-risk patients may obtain good curative effect in the treatment of single drug taxane chemotherapy combined with double target therapy.

The project plans to adopt an ambispective cohort study, based on the large sample breast disease cohort database established by the breast center of Peking University People's Hospital, and retrospectively include the HER2 positive breast cancer patients with clinical stage T1c, lymph node negative and receiving Taxanes combined with double target neoadjuvant therapy admitted to the center from January 1, 2019 to December 31, 2024. Patients of the same type were prospectively included from January 1, 2025 to December 31, 2028. Objective to evaluate the efficacy and safety of Taxanes combined with double target neoadjuvant therapy.

Eligibility

Sex

ALL

Min age

—

Max age

—

Healthy volunteers

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

Primary outcome measure(s)

pathology complete response — 4 months
Postoperative pathology confirmed that the primary breast lesions and axillary lymph nodes had no residual invasive tumor cells (ypT0/is and ypN0)

Trial sites (1)

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

More Shu Wang trials in China

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

Adjuvant Therapy for Intermediate Risk HER2 Positive, Lymph Node Negative Early Breast Cancer With Chemotherapy Combined Target Therapy Recruiting

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

Different Methods of Capecitabine in Patients With Non-PCR After Neoadjuvant Therapy for TNBC Recruiting

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 NCT06722599 on ClinicalTrials.gov ↗ ← All trials in China