Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-26 @ 11:08 AM
Study NCT ID:
NCT05872412
Status:
UNKNOWN
Last Update Posted:
2023-05-25
First Post:
2023-05-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Platinum-based Versus Non-platinum-based Neoadjuvant Chemotherapy in Triple-negative Breast Cancer
Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Organization:
Study Overview
Official Title:
Effect of Platinum-based Versus Non-platinum-based Neoadjuvant Chemotherapy in Triple-negative Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
NOT_YET_RECRUITING
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:
In this study, individuals with triple-negative breast cancer will receive either a platinum-based or non-platinum-based preoperative chemotherapy treatment. This study will help us identify which option is the most effective and safe.
Detailed Description:
Breast cancer is a significant health concern, and triple-negative breast cancer (TNBC) is a particularly aggressive and lethal subtype. Chemotherapy is currently the only recommended systemic treatment for TNBC, with the standard regimen being a combination of anthracyclines and taxanes. Platinum agents have shown promising results in TNBC neoadjuvant chemotherapy due to their ability to damage DNA and be more effective in tumors with dysfunctional DNA repair mechanisms. However, there is still a lack of consensus on the optimal neoadjuvant chemotherapy regimen for TNBC. This study will be conducted to compare the responses and toxicities of platinum-based versus non-platinum-based neoadjuvant chemotherapy in TNBC patients receiving neoadjuvant chemotherapy in the Department of Clinical Oncology of Bangabandhu Sheikh Mujib Medical University (BSMMU), Shahbagh, Dhaka. After pretreatment evaluation, a total of 82 patients who fulfill the inclusion and exclusion criteria will be divided into Arm A and Arm B by simple random sampling. After the completion of the chemotherapy, all patients will undergo surgical management. A postoperative histopathology report will be collected and assessed by the investigator. During the treatment, the patients will be monitored before each cycle of chemotherapy, including physical examinations and laboratory investigations. All the relevant data will be compiled on a master chart first, and then statistical analysis of the results will be obtained by using Windows-based computer software facilities with Statistical Packages for Social Sciences. The data will be analyzed using the Chi-square test and the "T' test. The results will be presented in tables, figures, and diagrams. A significant value of 'p' will be decided at a level of 0.05 in two-tailed tests.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: