The Efficiency for Stage II-III HR+/HER2+ Early Breast Cancer Patient With Standard Neoadjuvant Therapy in Real World.
- 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
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Stage II-III HR+/HER2+ Early Breast Cancer Standard Therapy Stage II-III HR+/HER2+ Early Breast Cancer
- Primary Outcome Measures
Name Time Method 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
Name Time Method Best overall response rate (BORR) [ Time Frame: During neoadjuvant treatment through 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