Recurrence Score-guiding Chemotherapy in Non-pCR HR Positive HER2 Negative Breast Cancer After Neoadjuvant Therapy (RSBNAT)
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, neoadjuvant, multiple gene detection
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
No Intervention
Experimental
No Intervention
Low risk Capecitabine
Low risk control
High risk Capecitabine
High risk control
Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based low recurrence risk receiving capecitabine.
Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based low recurrence risk NOT receiving any additional chemotherapy.
Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based high recurrence risk receiving capecitabine.
Patients after neoadjuvant chemotherapy evaluated as non-pCR have multiple gene test based high recurrence risk NOT receiving any additional chemotherapy.