Adjuvant Chemotherapy for Triple Negative Breast Cancer Patients With Residual Disease After Neoadjuvant Chemotherapy
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.
This study is a multi-center, randomized, phase II study. TNBC patients with residual
 invasive disease (invasive breast tumor size≥1cm and/or positive axillary lymph nodes) after
 platinum and taxanes based neoadjuvant chemotherapy are enrolled (n = 286). Patients are
 assigned to the chemotherapy group or the observation group at a 1:1 ratio randomly 4-6 weeks
 after surgery. Patients in the chemotherapy group are given anthracycline combined with
 cyclophosphamide regimen for 4 cycles. At the same time, the blood and tissue samples are
 collected for relevant tests. Follow up every 3-6 months and record recurrences and deaths.
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).