Docetaxel by 1 Hour Infusion Followed by 24 Hour Infusion of Cisplatin Plus Capecitabine as Neoadjuvant Chemotherapy for Locally Advanced Breast Cancer
This is an open-label phase II trial designed to test the effect and toxicity profile of
combination of docetaxel, cisplatin, and capecitabine in locally advanced breast cancer
patients.Breast cancer is one of the leading causes of cancer death for women in Taiwan.
Despite the advance in multidisciplinary treatment, a significant number of patients
eventually develop metastatic disease, especially those who present with locally advanced
breast cancer (LABC). LABC remains an important and challenging problem in practice. In
LABC, treatment strategies that include neoadjuvant chemotherapy have several potential
advantages: early initiation of systemic therapy, in vivo assessment of response, and
downstaging of primary tumor and regional lymphatic metastases, which makes
breast-conserving surgery an option for many. The potential theoretical shortcomings include
delay in local treatment, introduction of drug resistance, and unreliability of clinical
staging. In practice, the advantages have exceeded the disadvantages. Clinical trial has
demonstrated that docetaxel and capecitabine is highly effective in the treatment of
metastatic breast cancer. On the other hand, our previous study has demonstrated that
combination of taxane and cisplatin is highly effective in the treatment of locally advanced
and metastatic breast cancer. We design a combination chemotherapy using docetaxel with
cisplatin and capecitabine in the treatment of locally advanced breast cancer.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint of this phase II trial is the objective response rate of the regimen.
Yen-Shen Lu, M.D.
Department of Oncology , National Taiwan University Hospital
Taiwan: Department of Health