MedPath

The Efficiency for Stage II-III HR+/HER2+ Early Breast Cancer Patient With Standard Neoadjuvant Therapy in Real World.

Recruiting
Conditions
Breast Cancer
Interventions
Drug: Standard Therapy
Registration Number
NCT05263570
Lead Sponsor
Shengjing Hospital
Brief Summary

To observe the efficiency for patient with stage II-III HR+/HER2+ early breast cancer with standard neoadjuvant therapy, a retrospective, multicenter study in real world settings.

Detailed Description

This study collected patients used standard neoadjuvant therapy (TCbHP/THP/EC-THP/AC-THP) among stage II-III HR+/HER2+ early breast cancer, and to describe patient clinical characteristics and clinical outcomes of them in real world settings.

Recruitment & Eligibility

Status
RECRUITING
Sex
Female
Target Recruitment
200
Inclusion Criteria
  • Age ≥18 years or older
  • HR+/HER2- breast cancer diagnosis based on local standards
  • Women having stage II-III breast cancer diagnosed based on AJCC cancer staging system (8th edition) who will be admitted because of breast cancer for the first time
  • Standard Therapy, determined at the discretion of the investigator, including (TCbHP/THP/EC-THP/AC-THP)
  • Complete medical history was available
  • Karnofsky Performance Status (KPS) Scale score ≥ 70
Read More
Exclusion Criteria
  • Women who have received any form of anti-tumor treatment - (chemotherapy, radiotherapy, molecular targeted therapy, or endocrine therapy)
  • Pregnant or breast-feeding women
  • Those who have bilateral breast cancer, inflammatory breast cancer or occult breast cancer
  • Those who have stage IV breast cancer
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Stage II-III HR+/HER2+ Early Breast CancerStandard TherapyStage II-III HR+/HER2+ Early Breast Cancer
Primary Outcome Measures
NameTimeMethod
Total pathological complete response (tpCR)through study completion, an average of 1 year

tpCR is defined as the absence of residual invasive cancer on resected breast specimen and the sampled regional lymph nodes as shown by hematoxylin-eosin staining after completion of the neoadjuvant treatment.

Secondary Outcome Measures
NameTimeMethod
Best overall response rate (BORR) [ Time Frame: During neoadjuvant treatmentthrough study completion, an average of 1 year

The proportion of patients who respond to the treatment at any study time point

Residual cancer burden (RCB)through study completion, an average of 1 year

RCB score is obtained according to pathological evaluation after completion of neoadjuvant treatment and surgery

Trial Locations

Locations (1)

Shengjing Hospital of China Medical University

🇨🇳

Shenyang, Liaoning, China

© Copyright 2025. All Rights Reserved by MedPath