A Prospective, Randomized, Open, Multi-center Phase III Clinical Study Comparing Efficacy and Safety of Sequential T-FEC and TX-XEC as Post-operative Adjuvant Chemotherapy Options for the Treatment of Triple-negative Breast Cancer
Post-operative adjuvant chemotherapy has been shown to improve overall survival, delay local
relapse and reduce distant metastasis by multiple large-scale prospective clinical trial. In
registry clinical trial for Capecitabine conducted by O Shaughnessy, it revealed that a
combined chemotherapy of Capecitabine and Docetaxel achieved better outcomes compared with
Docetaxel alone. And the significant effect of Capecitabine was also evidenced by CHAT trial
in which Trastuzumab/Docetaxel/Capecitabine regimen was proved to perform greater than
Trastuzumab/Docetaxel regimen. In addition to better outcomes, Capecitabine also showed good
tolerance and safety profile. In 2009, Finnish Breast Cancer Group published their study
results from FinXX clinical trial on Lancet Oncology, and in this trial, they compared the
efficacy between sequential Docetaxel (3 cycles) followed by 3 cycles of
Fluorouracil/Epirubicin/Cyclophosphamide (FEC) and sequential Docetaxel and Capecitabine (3
cycles) followed by 3 cycles of Capecitabine/Epirubicin/Cyclophosphamide (XEC) in lymph
positive or high-risk lymph negative early-stage breast cancer patients. And their results
showed a better outcome in TX-XEC regimen. 5-year follow-up analysis of this trial revealed
that combined Capecitabine regimen can bring more significant clinical benefits to
triple-negative breast cancer patients. Another clinical trial NO1062 released their
preliminary results on comparison of AC-T and AC-XT regimens and it showed that combined
Capecitabine regimen can significantly improve overall survival and this effect is more
obvious in triple--negative breast cancer patients.
Based on the results of FinXX and NO1062, it's of great value to optimize combined
Capecitabine regimen and clarify involved questions, such as whether the efficacy of
Capecitabine is related to its treatment course or not, whether Capecitabine should be
combined into current standardized chemotherapy or a sequential therapy. Also, there are
still no clear conclusions on the best post-operative adjuvant chemotherapy for
triple--negative breast cancer patients. Especially in Chinese population, the efficacy and
safety of Capecitabine in adjuvant chemotherapy has not been well established. So it's
necessary to explore reasonable dosage, safety profile and efficacy of combined Capecitabine
therapy. Based on this purpose, this study is hoped to compare efficacy and safety of
sequential Docetaxel followed by Fluorouracil/Epirubicin/Cyclophosphamide (FEC) and
sequential Docetaxel and Capecitabine followed by Capecitabine/Epirubicin/Cyclophosphamide
(XEC) as post-operative adjuvant chemotherapy in the treatment of triple-negative breast
cancer in Chinese population.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
5-year disease free survival
Including local relapse, distant metastasis, contralateral breast cancer, second primary cancer or death from any cause
5 year after the completion of chemotherapy
No
Zhimin Shao, M.D.
Principal Investigator
China Breast Cancer Clinical Study Group
United States: Institutional Review Board
EBC protocol 1.1
NCT01642771
June 2012
May 2020
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