Ignite Creation Date:
2024-05-06 @ 12:52 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03876886
Status:
RECRUITING
Last Update Posted:
2019-03-21
First Post:
2019-03-14
Brief Title:
The Trial Comparing Dose-dense AC-T With TP as Adjuvant Therapy for TNBC With Homologous Recombination Repair Deficiency
Sponsor:
Chinese Academy of Medical Sciences
Organization:
ChineseAMS
Study Overview
Official Title:
Randomized Phase Ⅲ Trial Comparing Dose-dense Epirubicin and Cyclophosphamide Followed by Paclitaxel With Paclitaxel Plus Carboplatin as Adjuvant Therapy for Triple-negative Breast Cancer With Homologous Recombination Repair Deficiency
Status:
RECRUITING
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this trial is to compare the 3-year disease-free survival of dose-dense epirubicin and cyclophosphamide followed by paclitaxel with paclitaxel plus carboplatin as adjuvant therapy for triple-negative breast cancer with homologous recombination repair deficiency
The other purpose of this trial is to observe the patients tolerance
The other purpose of this trial is to observe the patients tolerance
Detailed Description:
Triple-negative breast cancer TNBC lack the expression of oestrogen receptor ER progesterone receptorPR and human epidermal growth factor receptor 2 HER2 and characterizes an aggressive behavior with higher risk of recurrence and death compared to other breast cancer subtypes Little therapeutic progress has been made in adjuvant therapy in TNBC during the past decades and the standard of care is still missing
Pre-clinical and clinical data suggest that platinum-based regimens represent an emerging therapeutic option for selected patients with homologous recombination repair deficiency HRD The HR system is critical in regulating and maintaining genome stability and is one of the most commonly altered systems in TNBCs up to 15-20 TNBC patients carry germline BRCA12 mutations Other HR genes included PALB2 RAD51 etc Tumors that harbor HRD possess an increased burden of genomic aberrations and lesions and have been shown to have increased sensitivity to DNA crosslinking agents such as platinum salts Platinum-based regimens have been encouraging in TNBC patients with HRD given increases in both pathologic complete response pCR rates in neoadjuvant trials and objective response ratesORR in metastatic diseases Further information are needed on how platinum-containing therapies affect long-term outcomes in the adjuvant setting
In this trial the investigators intend to compare the 3-year disease-free survival DFS of dose-dense epirubicin and cyclophosphamide followed by paclitaxel with paclitaxel plus carboplatin as adjuvant therapy in high-risk node-negative or node-positive TNBC patients with HRD The other purpose of this trial is to observe the participants tolerance
Pre-clinical and clinical data suggest that platinum-based regimens represent an emerging therapeutic option for selected patients with homologous recombination repair deficiency HRD The HR system is critical in regulating and maintaining genome stability and is one of the most commonly altered systems in TNBCs up to 15-20 TNBC patients carry germline BRCA12 mutations Other HR genes included PALB2 RAD51 etc Tumors that harbor HRD possess an increased burden of genomic aberrations and lesions and have been shown to have increased sensitivity to DNA crosslinking agents such as platinum salts Platinum-based regimens have been encouraging in TNBC patients with HRD given increases in both pathologic complete response pCR rates in neoadjuvant trials and objective response ratesORR in metastatic diseases Further information are needed on how platinum-containing therapies affect long-term outcomes in the adjuvant setting
In this trial the investigators intend to compare the 3-year disease-free survival DFS of dose-dense epirubicin and cyclophosphamide followed by paclitaxel with paclitaxel plus carboplatin as adjuvant therapy in high-risk node-negative or node-positive TNBC patients with HRD The other purpose of this trial is to observe the participants tolerance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None