Recruiting
Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy
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.
ClinicalTrials.gov IDNCT04437160
PhasePHASE2
Enrollment286
SponsorChinese Academy of Medical Sciences
Age18 Years
SexALL
Conditions studied
Triple Negative Breast Cancer
About this study
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.
Interventions
- Drug: Epirubicin or Pirarubicin — Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV, q21d\*4cycls
- Drug: Cyclophosphamide — Cyclophosphamide 600mg/m2 IV, q21d\*4cycls
Primary outcomes
- RFS (median 5 years)
Eligibility information
Inclusion Criteria:
* 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.
* Patients should have undergone adequate tumor excision in the breast and lymph nodes after neoadjuvant chemotherapy.
* Residual invasive disease must be ≥1cm in the breast, and/or have positive axillary lymph nodes observed on pathologic exam after neoadjuvant chemotherapy.
* ECOG Performance Status: 0-1.
* Patients without severe heart, lung, liver and kidney disease.
* Adequate hematologic and end-organ function.
* No more than 6 weeks may elapse between definitive breast surgery and randomization.
Exclusion Criteria:
* 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.
* Patients who are not suitable for anthracycline evaluated by investigators.
* Prior history of other malignancy (except carcinoma in situ).
Study locations
- Cancer Hospital & Institute Chinese Academy of Medical Sciences (CAMS), Beijing, Beijing Municipality 100021 China
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.