Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01779531

Compare the Outcomes of XT and XEC Adjuvant Chemotherapy in HER2-negative Luminal B Breast Cancer Patients

Human Epidermal Growth Factor 2 Negative Carcinoma of Breast Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01779531
Study type Observational
Source Guangdong Academy of Medical Sciences
Contact Liao Ning, MD,PhD
Phone 13903054106
Email drliao_ning@hotmail.com
Status Not yet recruiting
Phase N/A
Start date January 2013
Completion date June 2015
View Details
See also
  Status Clinical Trial Phase
Completed NCT02894398 - Study in Women With Advanced Breast Cancer Receiving Palbociclib With AI or Fulvestrant Phase 2
Recruiting NCT02175446 - Safety and Efficacy Study of Eribulin in Combination With Bevacizumab for Second-line Treatment HER2- MBC Patients Phase 2
Terminated NCT01918306 - GDC-0941 and Cisplatin in Treating Patients With Androgen Receptor-Negative Triple Negative Metastatic Breast Cancer Phase 1/Phase 2
Completed NCT01885013 - Myocet + Cyclophosphamide + Metformin Vs Myocet + Cyclophosphamide in 1st Line Treatment of HER2 Neg. Metastatic Breast Cancer Patients Phase 2
Completed NCT01935492 - 8 Continuous vs 8 Intermittent Cycles in First and Second Line in HER2/Neu Neg Metastatic Breast Cancer Phase 3
Recruiting NCT05735080 - Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer Phase 1/Phase 2
Active, not recruiting NCT02668666 - Palbociclib in Combination With Tamoxifen as First Line Therapy for Metastatic Hormone Receptor Positive Breast Cancer Phase 2
Terminated NCT02824575 - Rebastinib Plus Antitubulin Therapy With Paclitaxel or Eribulin in Metastatic Breast Cancer Phase 1
Terminated NCT02823262 - A Breast Cancer Treatment Decision Aid for Women Aged 70 and Older N/A
Completed NCT02806817 - ME-344 in Early HER2-negative Breast Cancer With Antiangiogenic-induced Mitochondrial Metabolism Early Phase 1
Terminated NCT01394211 - Neo-adjuvant Therapy With Anastrozole Plus Pazopanib in Stage II and III ER+ Breast Cancer Phase 2
Not yet recruiting NCT06338644 - Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.
Not yet recruiting NCT06348134 - Assessing the Efficacy and Safety of Anti-HER2 Therapy in Nigerian Women With HER2+ Breast Cancer Before and After Surgery Phase 2
Completed NCT01288261 - Paclitaxel and Bavituximab in Treating Patients With HER2-Negative Metastatic Breast Cancer Phase 1
Completed NCT03285568 - Patterns of Prescribing and Monitoring of Palbociclib
Active, not recruiting NCT02623972 - A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer Phase 2
Terminated NCT01905592 - A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients Phase 3
Recruiting NCT06264921 - A Study With NKT3447 for Adults With Advanced/Metastatic Solid Tumors Phase 1
Not yet recruiting NCT03854617 - A Study to Evaluate the Efficacy and Safety of Oral Navelbine in Female Patients With HER2-Negative Metastatic Breast Cancer Phase 2
Recruiting NCT02404051 - Fulvestrant and EVerolimus Plus EXemestane in Metastatic Breast Cancer Phase 3