A Phase III,Randomized ,Multi-center Clinical Trail to Compare the Outcomes of XT and XEC Adjuvant Chemotherapy Protocol in HER-negative Luminal B Breast Cancer Patients Who Reached Pathologic Response After XT Neoadjuvant Chemotherapy
Individualized treatment of breast cancer has become one of the main directions in the
clinical and research areas of breast cancer,and the individualized treatment of the
estrogen receptor(ER) positive patients which covered 65% of total cases is of vital
importance. Historical research showed that among the ER-positive and HER2-negative breast
cancer,Luminal B breast cancer with Ki67>14% is more likely to be benefited from
chemotherapy,compared with the Luminal A breast cancer with Ki67<14%. And the results of our
previous research showed that, the neoadjuvant XT protocol has more than 17% pCR rate in
Luminal B subtype breast cancer.However,to those who didn't reach pCR,we've got no evidence
whether switching to Anthracycline-based post operative protocol can benefit them.So
that,we sketch out a randomized controlled multicentric phase III clinical trail.HER2
negative Luminal B subtype breast cancer patients are included. After 4 cycles of XT
protocol neoadjuvant chemotherapy ,those who reach PR but not pCR are randomly divided into
the group treated with XT protocol and the group with XEC protocol ,then compare the DFS and
OS of two subgroup.
Observational
Observational Model: Case Control, Time Perspective: Prospective
Disease free survival after adjuvant chemotherapy within five years
Within 5 years after adjuvant chemotherapy,we should evaluate disease free survival and overall survival rates as the most important outcome measure.
Within 5 years after adjuvant chemotherapy
Yes
Liao Ning, MD,PhD
Study Director
Guangdong Academy of Medical Sciences
China: Ethics Committee
GGHBCRG
NCT01779531
January 2013
June 2015
Name | Location |
---|