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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Standard Therapy


Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stage II-III HR+/HER2+ Early Breast Cancer<br>Stage II-III HR+/HER2+ Early Breast Cancer | Drug: Standard Therapy<br>* Standard Therapy, including TCbHP, THP, EC-THP, AC-THP<br>* Other names: TCbHP, THP, EC-THP, AC-THP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total pathological complete response (tpCR) | 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. | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best overall response rate (BORR) [ Time Frame: During neoadjuvant treatment | The proportion of patients who respond to the treatment at any study time point | through study completion, an average of 1 year | 
| Residual cancer burden (RCB) | RCB score is obtained according to pathological evaluation after completion of neoadjuvant treatment and surgery | through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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standard Therapy （TCbHP/THP/EC-THP/AC-THP）