Chemotherapy Effect Clinical Trial
Official title:
Mutation Scores and Differential Protein Evaluating Efficacy in Neo-adjuvant Chemotherapy and the Non-PCR Patients Treated With Sequential Nalvelbine and Xeloda in HER2(-) Luminal B Breast Cancer
We plan to carry out a prospective, randomized, open phase III clinical trial which sponsored by the Tianjin Medical University Cancer Hospital and Institute. The primary aim is to evaluate pCR of DT and ET regimen as neoadjuvant chemotherapy in the treatment of HER2 negative Luminal B breast cancers and the correlation of pCR respectively with the susceptible gene mutation scores and differential protein identified by proteomics. For patients with pCR, the association between the 5 year DFS and susceptible gene mutation scores and differential protein identified by proteomics will be evaluated. All Non-pCR patients will receive NX chemotherapy for 4 cycles, and to evaluate correlations between 5 year DFS of these patients respectively with susceptible gene mutation scores and differential protein identified by proteomics, and to evaluate the safety of neoadjuvant chemotherapy and sequential adjuvant NX regimen therapy. Meanwhile, we will verify susceptible gene mutation scores and differential protein identified by proteomics are significant predictors of HER2 negative Luminal B breast cancer chemotherapy sensitivity and prognosis, and explore the feasibility of susceptible gene mutation scores and differential protein in clinical application.
This is a prospective, randomized, open phase III clinical trial which will be sponsored by the Tianjin Medical University Cancer Hospital and Institute. The primary aim is to evaluate pCR of Pegylated Liposomal Doxorubicin and Docetaxel (DT) Compared to Conventional Doxorubicin and Docetaxel (ET) regimen as neoadjuvant chemotherapy in the treatment of HER2 negative Luminal B breast cancers and the correlation of pCR respectively with the susceptible gene mutation scores and differential protein identified by proteomics. For patients with pCR, the association between the 5 year DFS and susceptible gene mutation scores and differential protein identified by proteomics will be evaluated. All Non-pCR patients will receive NX chemotherapy for 4 cycles, and to evaluate correlations between 5 year DFS of these patients respectively with susceptible gene mutation scores and differential protein identified by proteomics, and to evaluate the safety of neoadjuvant chemotherapy and sequential adjuvant Nalvelbine and Xeloda (NX) regimen therapy. Meanwhile, we will verify susceptible gene mutation scores and differential protein identified by proteomics are significant predictors of HER2 negative Luminal B breast cancer chemotherapy sensitivity and prognosis, and explore the feasibility of susceptible gene mutation scores and differential protein in clinical application. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06376604 -
Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies
|
N/A | |
Completed |
NCT03753542 -
Effect of Nurse-led Education on Parent's Anxiety and Depression on Managing Side Effects of Chemotherapy
|
N/A | |
Not yet recruiting |
NCT05022628 -
Clinical Study of Radiotherapy Combined With Donafenib for Neoadjuvant Treatment of Patients With HCC With Portal Vein Carcinoma Thrombosis
|
Phase 4 | |
Completed |
NCT04207359 -
Effects of Creatine Supplementation in Breast Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT04489173 -
TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer
|
Phase 2 | |
Completed |
NCT04173195 -
Comfort Talk (CT) During Outpatient Chemotherapy
|
N/A | |
Recruiting |
NCT06041477 -
Concurrently vs Sequentially Combined HAIC With Targeted and Immunotherapy in Potentially Resectable HCC
|
Phase 3 | |
Recruiting |
NCT05014399 -
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
|
||
Recruiting |
NCT03275194 -
HIPEC in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy
|
Phase 2 | |
Recruiting |
NCT04808466 -
Comparative Study of Lobaplatin and Paclitaxel in Advanced Gastric Cancer Patients With D2 Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy
|
Phase 2 | |
Recruiting |
NCT06421610 -
OPC5: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) in Patients With Malignant Pleural Effusion.
|
Phase 1 | |
Completed |
NCT05131490 -
Effect on Adaptation to Cancer of Mobile Application Developed for Gynecological Cancer Patients
|
N/A | |
Completed |
NCT04118322 -
The Effect of Peppermint Oil on Nausea, Vomiting and Retching in Cancer Patients Undergoing Chemotherapy
|
N/A | |
Recruiting |
NCT06043999 -
Salvage Chemotherapy Versus Total Mesorectal Resection for Local Resection Rectal Cancer Patients
|
N/A | |
Recruiting |
NCT05515796 -
Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors
|
Phase 2 | |
Not yet recruiting |
NCT04845490 -
Comparative Study of Mitomycin and Lobaplatin in Advanced Colorectal Cancer Patients With Radical Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy
|
Phase 2 | |
Recruiting |
NCT04989985 -
S-1 and Oxaliplatin (SOX) Plus Sintilimab in the Locally Advanced Esophagogastric Junction Adenocarcinoma
|
Phase 2 | |
Recruiting |
NCT05992337 -
New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.
|
||
Recruiting |
NCT05424692 -
Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy of Colorectal Cancer
|
N/A | |
Enrolling by invitation |
NCT04027478 -
Can Fasting Decrease the Side Effects of Chemotherapy?
|
N/A |