The Maintenance Regimen and Revised Regimen for Advanced Breast Cancer Survivors After First-line Salvage Therapy
Status:
Unknown status
Trial end date:
2020-02-08
Target enrollment:
Participant gender:
Summary
Worldwide, breast cancer is the most incident and prevalent cancer among women. Despite
advances in the treatment of advanced breast cancer (ABC) during the past decade, adjuvant
systemic therapy has yield little progression for such patients. ABC remains an incurable
disease, responsible for approximate 40,000 deaths annually and a median life expectancy of
no more than 3 years. The NCCN guidelines clearly define routine adjuvant chemotherapy
regimens for the early breast cancer, however, for the patients with recurrence and
metastasis, the choice of treatment options is not clear. In this trial, we choose the
patients with disease progression who received anthracycline and taxane adjuvant chemotherapy
after surgery. The patients received vinorelbine and gemcitabine (NG) or vinorelbine and
platinum (NP) regiments for 6 cycles. Then the patients with complete response (CR), partly
response (PR) and stable disease(SD) will be assigned to 3 groups, one group will receive the
original regiment for 3 cycles to maintain treatment, one group will receive the vinorelbine
for 6 cycles, the other group will receive the capecitabine for 6 cycles. Trasuzumab will be
used to patients if HER-2 positive. Endocrine therapy will be used if the hormone receptors
positive after the chemotherapy. The primary endpoint is to assess disease-free survival
(DFS), the secondary endpoint is to assess the overall survival (OS).