Compare the Outcomes of XT and XEC Adjuvant Chemotherapy in HER2-negative Luminal B Breast Cancer Patients
Human epidermalgrowth factor receptor-2(HER2) negative Luminal B subtype breast cancer patients are included. After 4 cycles of Capecitabine combined with Docetaxel(XT) protocol neoadjuvant chemotherapy ,those who reach partial response(PR) but not pathological complete response(pCR) are randomly divided into the group treated with XT protocol and the group with Capecitabine combined with Epirubicin and Cyclophosphamide(XEC) protocol ,then compare the disease free survival(DFS) and overall survival(OS) of two subgroup.
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||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|
- Disease free survival after adjuvant chemotherapy within five years [ Time Frame: Within 5 years after adjuvant chemotherapy ] [ Designated as safety issue: Yes ]Within 5 years after adjuvant chemotherapy,we should evaluate disease free survival and overall survival rates as the most important outcome measure.
- Overall survival after adjuvant chemotherapy within five years [ Time Frame: Within five years after adjuvant chemotherapy ] [ Designated as safety issue: Yes ]Within 5 years after adjuvant chemotherapy,we should evaluate overall survival (OR)rates as the most important outcome measure.
- Imaging evaluation after neoadjuvant chemotherapy [ Time Frame: within the 21 days after neoadjuvant chemotherapy ] [ Designated as safety issue: Yes ]After neoadjuvant chemotherapy,we should evaluate the status of patients as progress disease and then use the imaging evaluations as the proofs to plan their next therapeutic schedule or different grouping methods.
- Baseline evaluation [ Time Frame: before the neoadjuvant chemotherapy ] [ Designated as safety issue: Yes ]Baseline evaluation includes the issues of ECOG PS scores, primary tumor Imaging evaluation, evaluation and reserve of bone marrow and organ function evaluation.
Biospecimen Retention: Samples Without DNA
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01779531
|Contact: Liao Ning, MD,PhDfirstname.lastname@example.org|
|Guangdong Academy of Medical Sciences||Not yet recruiting|
|Guangzhou, Guangdong, China, 510080|
|Contact: Wen Ling Zhu 13763316144 email@example.com|
|Study Director:||Liao Ning, MD,PhD||Guangdong Academy of Medical Sciences|