Actively Recruiting

All Genders
NCT06700369

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

Led by Shu Wang · Updated on 2024-11-25

519

Participants Needed

1

Research Sites

886 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Neoadjuvant therapy is currently the standard treatment process for locally advanced breast cancer, especially for human epidermal growth factor receptor 2 (HER2) positive and triple negative breast cancer, which meets the requirements of tumor ≥ 2cm and/or lymph node positive, and the guidelines recommend neoadjuvant therapy as the first choice. Chemotherapy combined with trastuzumab and pertuzumab is the standard neoadjuvant therapy for HER2 positive breast cancer patients. Taxane plus carboplatin (TCb) is the first choice of chemotherapy recommended by major guidelines; As an alternative, single drug Taxane (T) is also listed as class I recommendation in the latest CSCO guidelines, but the level of evidence is slightly insufficient. Considering the defects such as large side effects of combined chemotherapy, whether single drug chemotherapy can be used as the first choice for some people under the support of targeted drugs remains to be studied. This project plans to a 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 patients with clinical stage T2 and above and/or lymph node positive breast cancer who received neoadjuvant therapy (TCbHP or THP) from January 1, 2015 to December 31, 2024. Patients of the same type were prospectively included from January 1, 2025 to December 31, 2028. The effectiveness and safety of TCbHP and THP as a neoadjuvant therapy were compared.

CONDITIONS

Official Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with HER2 positive breast cancer by biopsy at Peking University People's Hospital
  • Clinical stage II or III breast cancer (tumor size 2cm or larger and/or lymph node positive) without distant metastasis
  • Received treatment at Peking University People's Hospital with hospitalization records
  • Signed consent to participate in the PKUPH breast disease cohort study
Not Eligible

You will not qualify if you...

  • Missing clinical or pathological data such as imaging or pathology reports
  • Having metastatic or bilateral breast cancer
  • Receiving anti-tumor therapy in other clinical trials, including endocrine or targeted therapy
  • Receiving neoadjuvant treatments other than the established regimens in this study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Peking University People's Hospital

Beijing, Beijing Municipality, China, 100044

Actively Recruiting

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Research Team

Y

yuan peng, doctor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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