This study will evaluate the efficacy and safety of antharcycline-based adjuvant chemotherapy compared with observation in triple negative breast cancer (TNBC) patients with residual invasive disease after platinum and taxanes based neoadjuvant chemotherapy.
Patients with histologically confirmed invasive adenocarcinoma of the breast.
Triple negative breast cancer: hormone receptor negative (ER < 10% and PgR < 10%) and HER2 negative (IHC 0/1+ or ISH non-amplified), as defined by the local pathology laboratory.
Clinical stage at presentation: T1-4, N0-3, M0, with indications for neoadjuvant chemotherapy.
Patient must have received platinum and taxanes neoadjuvant chemotherapy for at least 4 cycles and no tumor progression occurred.
Previous neoadjuvant chemotherapy with anthracycline or other drugs (except platinum and taxanes).
Previous neoadjuvant chemotherapy with platinum or taxanes alone.
Patients have received other adjuvant therapy.
Comprehensive medical examinations have revealed distant metastases before randomization.
Parallel
Epirubicin or Pirarubicin
DrugEpirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV, q21d\*4cycls
Cyclophosphamide
DrugCyclophosphamide 600mg/m2 IV, q21d\*4cycls
RFS
RFS defined as the time from randomization to the first recurrence event or death through the end of study
OS
OS defined as the time from randomization to all-cause death through the end of study
Percentage of patients with adverse events
To assess the toxicity of adjuvant chemotherapy by CTCAE v5.0
Changes in patient-reported quality of life
To assess the mean changes from baseline score in patient-reported quality of life using EORTC QLQ-C30
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