Research on the Potential Mechanisms Underlying the Efficacy Differences in Specific Neoadjuvant Treatment Regimens for Different Subtypes of Breast Cancer

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This study is a single-center, open-label, prospective, clinical cohort study. It enrolled patients in three subgroups: triple negative, HR+HER2-, or HR-HER2+ subtypes, who will receive neoadjuvant treatment according to guidelines. Patients in each subgroup will be divided into two categories: those responsive to neoadjuvant therapy and those resistant to it, based on the efficacy of the treatment. Tumor tissue samples from all enrolled patients before and after neoadjuvant therapy will be collected. We will explore transcriptomic differences in neoadjuvant therapy responders or resisters under the same treatment regimen, as well as transcriptomic changes in tumor tissue before and after treatment, based on single-cell sequencing and spatial transcriptomic technology.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 75
Healthy Volunteers: f
View:

• Voluntary enrollment, able to understand and sign the informed consent form;

• Female, aged 25 to 70;

• Meet the indications for neoadjuvant therapy (based on the indicated population clearly defined in the 2023 CSCO Breast Cancer Diagnosis and Treatment Guidelines);

• No previous systemic treatment for breast cancer;

• The neoadjuvant treatment regimen met the inclusion requirements: triple-negative breast cancer (T-EC+antiPD-1/T-EC/antiPD-1) HER2+ HR-breast cancer (EC-THP/HP), HER2-HR+ breast cancer (AI/AI+CDK4/6i);

• Tumor specimens can be obtained (including puncture, minimally invasive, incision biopsy, and surgery);

• A complete pathological report can be obtained.

Locations
Other Locations
China
Xijing hospital
RECRUITING
Xi'an
Contact Information
Primary
Ju liang J L Zhang
vascularzhang@163.com
029-84775271
Time Frame
Start Date: 2024-04-01
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 71
Treatments
Experimental: TNBC-Chemotherapy combined with immunotherapy
Patients with TNBC subtype breast cancer receive chemotherapy combined with immunotherapy
Experimental: TNBC-Chemotherapy
Patients with TNBC subtype breast cancer receive chemotherapy
Experimental: TNBC-Immunotherapy
Patients with TNBC subtype breast cancer receive immunotherapy
Experimental: HER2+HR- -EC-THP chemotherapy combined with targeted therapy regimen
Patients with HER2+HR- subtype breast cancer receive EC-THP chemotherapy combined with targeted therapy
Experimental: HER2+HR -- HP targeted treatment regimen
Patients with HER2+HR- subtype breast cancer receive HP-targeted therapy regimens
Experimental: HER2-HR+-AI+CDK4/6i Endocrine combined with CDK4/6 inhibitor regimen
Patients with HER2-HR+ breast cancer were given a treatment regimen of endocrine combined with CDK4/6 inhibitors
Experimental: HER2-HR+-AI Endocrine inhibitor regimen
Endocrine therapy regimens were given to patients with HER2-HR+ breast cancer
Related Therapeutic Areas
Sponsors
Leads: Xijing Hospital

This content was sourced from clinicaltrials.gov