Recurrence Score-guiding Chemotherapy in Non-pCR HR Positive HER2 Negative Breast Cancer After Neoadjuvant Therapy

Study Overview
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Brief Summary
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The luminal subtype of breast cancer means hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+HER2-), which counted 60%-70% of breast cancer but achieve low pathologic complete response (pCR) rate (7.5%-15%) in neoadjuvant chemotherapy. It is controversial whether additional chemotherapy after surgery is necessary for those non-pCR HR+HER2- patients. Multiple gene is a mature diagnose tool for recurrence score in adjuvant treatment strategy. This study is to investigating the value of multi gene detection tool based recurrence score for guiding additional chemotherapy after surgery in HR+HER2- non-pCR breast cancer.

Detailed Description
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This study is designed as stratified cluster randomized, parallel-control research. The HR+HER2- breast cancer patients after neoadjuvant chemotherapy (including anthracyclines and taxane, at least 6 cycles) assessed non-pCR are recruited, receiving multiple gene test before neoadjuvant treatment and after surgery. After enrollment, the patients were stratified according to multiple gene test based recurrence risk level (High risk or Low risk) and then randomized into two groups respectively in each cluster: receiving additional chemotherapy (Capecitabine) group or negative control group. The primary endpoint is 2-year disease free survival. The second endpoint is 5-year disease free survival (DFS), 2-year overall survival (OS), 5-year OS, safety of additional chemotherapy. The exploratory endpoint is the variety of multiple gene test based recurrence risk after neoadjuvant chemotherapy in non-pCR patients.

Official Title
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Multi Gene Detection Tool Based Recurrence Score-guiding Chemotherapy in Non-pathologic Complete Response HR Positive and HER2 Negative Breast Cancer After Neoadjuvant Treatment

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Capecitabine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Invasive breast cancer at the first diagnosed Clinical stage cT1-4cN0-3M0 (AJCC 8th), receiving neoadjuvant chemotherapy at least 6 cycles Neoadjuvant chemotherapy regimen should include anthracyclines and taxane Primary tumor HR+(ER+ or PR+) and HER2 negative before neoadjuvant chemotherapy Pathological evaluation non-pCR after neoadjuvant chemotherapy (residual invasive cancer in primary tumor) Exclusion Criteria: Metastasis, recurrent breast cancer or receiving other treatment before neoadjuvant chemotherapy Pregnant breast cancer IHC or FISH test of primary tumor confirmed HER2 positive at anytime Complete fewer than 6 cycles chemotherapy before surgery Deficiency of surgery after neoadjuvant Contraindication of chemotherapy or surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low risk Capecitabine<br>Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based low recurrence risk receiving capecitabine. | Drug: Capecitabine<br>* Capecitabine 2500mg/m2/day, d1-d14, every 3 weeks a cycle for 8 cycles<br>* Other names: additional chemotherapy;|
| No Intervention: Low risk control<br>Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based low recurrence risk NOT receiving any additional chemotherapy. | |
| Experimental: High risk Capecitabine<br>Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based high recurrence risk receiving capecitabine. | Drug: Capecitabine<br>* Capecitabine 2500mg/m2/day, d1-d14, every 3 weeks a cycle for 8 cycles<br>* Other names: additional chemotherapy;|
| No Intervention: High risk control<br>Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based high recurrence risk NOT receiving any additional chemotherapy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-year DFS | disease-free survival rate in 2 years | 2 years after randomized | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 5-year DFS | disease-free survival rate in 5 years | 5 years after randomized | 
| 2-year OS | overall survival rate in 2 years | 2 years after randomized | 
| 5-year OS | overall survival rate in 5 years | 5 years after randomized | 
| Aside effect | any aside effect induced by additional chemotherapy (Capecitabine) | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, neoadjuvant, multiple gene detection