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

NCT07012720 | Recruiting

• 1 other identifier: KY20242085-C-1
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

Single-cell sequencing

Outcome Measures

Primary Outcomes (1)

• RECIST1.1 Evaluates clinical efficacy

  At the end of neoadjuvant therapy, based on the preoperative MRI imaging results, the clinical efficacy was evaluated according to the Response Evaluation Criteria (RECIST1.1) for Solid tumors: complete response (CR) or partial response (PR), stable disease (SD) or disease progression (PD). The efficacy of neoadjuvant therapy was set as the primary endpoint of the study.

  At 24 weeks

Secondary Outcomes (3)

• residual cancer burden（RCB）

  Two weeks after the operation

• Pathological complete response (pCR)

  Two weeks after the operation

• Disease-free survival (DFS)

  Greater than or equal to 5 years after the operation.

Study Arms (7)

TNBC-Chemotherapy combined with immunotherapy

EXPERIMENTAL

Patients with TNBC subtype breast cancer receive chemotherapy combined with immunotherapy

Diagnostic Test: Single-cell sequencing and spatial transcriptome

TNBC-Chemotherapy

EXPERIMENTAL

Patients with TNBC subtype breast cancer receive chemotherapy

Diagnostic Test: Single-cell sequencing and spatial transcriptome

TNBC-Immunotherapy

EXPERIMENTAL

Patients with TNBC subtype breast cancer receive immunotherapy

Diagnostic Test: Single-cell sequencing and spatial transcriptome

HER2+HR- -EC-THP chemotherapy combined with targeted therapy regimen

EXPERIMENTAL

Patients with HER2+HR- subtype breast cancer receive EC-THP chemotherapy combined with targeted therapy

Diagnostic Test: Single-cell sequencing and spatial transcriptome

HER2+HR -- HP targeted treatment regimen

EXPERIMENTAL

Patients with HER2+HR- subtype breast cancer receive HP-targeted therapy regimens

Diagnostic Test: Single-cell sequencing and spatial transcriptome

HER2-HR+-AI+CDK4/6i Endocrine combined with CDK4/6 inhibitor regimen

EXPERIMENTAL

Patients with HER2-HR+ breast cancer were given a treatment regimen of endocrine combined with CDK4/6 inhibitors

Diagnostic Test: Single-cell sequencing and spatial transcriptome

HER2-HR+-AI Endocrine inhibitor regimen

EXPERIMENTAL

Endocrine therapy regimens were given to patients with HER2-HR+ breast cancer

Diagnostic Test: Single-cell sequencing and spatial transcriptome

Interventions

Single-cell sequencing and spatial transcriptome DIAGNOSTIC_TEST

Tumor tissue samples of all enrolled patients before and after neoadjuvant therapy were collected. Based on single-cell sequencing and spatial transcriptome technology, the transcriptomic differences in neoadjuvant therapy response or treatment resistance under the same treatment regimen, as well as the transcriptomic changes of tumor tissues before and after treatment were explored.

HER2+HR -- HP targeted treatment regimen; HER2+HR- -EC-THP chemotherapy combined with targeted therapy regimen; HER2-HR+-AI Endocrine inhibitor regimen; HER2-HR+-AI+CDK4/6i Endocrine combined with CDK4/6 inhibitor regimen; TNBC-Chemotherapy; TNBC-Chemotherapy combined with immunotherapy; TNBC-Immunotherapy

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Tumor specimens can be obtained (including puncture, minimally invasive, incision biopsy, and surgery);
• A complete pathological report can be obtained.

You may not qualify if:

• The patient did not sign the informed consent form;
• Tumor specimens cannot be obtained (including puncture, minimally invasive, incision biopsy, and surgery);
• Patients with severe systemic infections or accompanied by other serious diseases;
• Have received cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any previous reason;
• Does not meet the indications for neoadjuvant therapy;
• Neoadjuvant treatment regimens are not included in the neoadjuvant treatment regimens defined in this study;
• (2) Furthermore, the subjects may withdraw from this study under the following circumstances:
• Withdrawal decided by the researcher:
• A: The patient does not meet the indications for the above-mentioned designated neoadjuvant regimen; B: In cases where the subjects are not suitable to continue the trial during the research process, such as when the patients cannot tolerate immunotherapy or chemotherapy, the established neoadjuvant treatment plan needs to be terminated; C: Those who accept the neoadjuvant treatment regimen specified in this study and show disease progression in the cycle evaluation need to terminate the neoadjuvant treatment in advance and undergo surgical resection of the tumor tissue.
• D: Adverse events occurred. It was judged by the researchers that continuing to participate in the study would have an adverse impact on the safety of the subjects.
• E: Subjects with poor compliance, which affects the assessment of tolerance; F: The researcher requests the subjects to withdraw from the study for any medical reason; G: The researchers believe that the subjects have other circumstances that make them unsuitable to continue participating in the trial.
• Voluntary withdrawal of the subjects:
• A: The subject was unwilling to continue participating in the study and voluntarily withdrew the informed consent form.
• B: Loss to follow-up (Before loss to follow-up, subjects who have completed three visits should be attempted to be contacted).

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

Xijing hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Ju liang J L Zhang

CONTACT

029-84775271; vascularzhang@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 10, 2025
• Study Start: April 1, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): April 30, 2027
• Last Updated: June 10, 2025

Record last verified: 2025-05

Locations

CN (1)