Ignite Creation Date:
2024-05-06 @ 3:46 AM
Last Modification Date:
2024-10-26 @ 11:38 AM
Study NCT ID:
NCT02365805
Status:
COMPLETED
Last Update Posted:
2017-03-13
First Post:
2014-12-30
Brief Title:
Randomized CT to Evaluate Efficacy of Neoadjuvant Chemotherapy Customized by Levels of BRCA1-HER2 Negative Breast Cancer
Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Organization:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Study Overview
Official Title:
Randomized Open-label Multicentric Phase II Clinical Trial to Evaluate the Efficacy of a Neoadjuvant Chemotherapy Scheme Customized by Levels of BRCA1 in Women With Primary HER2 Negative Breast Cancer The BERNAQ Clinical Trial
Status:
COMPLETED
Status Verified Date:
2017-03
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:
BERNAQ
Brief Summary:
Neoadjuvant chemotherapy NAC is increasingly used for early-stage operable breast cancer Response of breast cancer to NAC is correlated with survival patients who obtain greatest survival advantage are those who attain complete response of their primary tumor BReast Cancer 1 BRCA1 plays a crucial role in DNA repair and associations between BRCA1 mRNA expression and sensitivity to platinum andor resistance to taxanes has been previously documented We propose a two-arm randomized multi-centre open-label phase II study to compare the efficacy and tolerability of NAC customized by BRCA 1 levels versus standard FEC chemotherapy being pathological complete response the primary endpoint
Detailed Description:
Neoadjuvant chemotherapy NAC is increasingly used for early-stage operable breast cancer Response of breast cancer to NAC is correlated with survival patients who obtain greatest survival advantage are those who attain complete response of their primary tumorBReast Cancer 1 BRCA1 plays a crucial role in DNA repair Associations between BRCA1 mRNA expression and sensitivity to platinum andor resistance to taxanes are previously documented Improving complete response rates with NAC we can improve outcomes in breast cancer If we establish biomarkers which predict better response we may optimized treatment by individualized breast cancer care Therefore we propose a two-arm randomized multi-centre open-label phase II study The study will compare the efficacy and tolerability of NAC customized by BRCA 1 levels versus standard chemotherapy being pathological complete response the primary endpoint Women with primary Her-2 negative breast cancer who have not undergone previous treatment for invasive breast cancer will be randomized to receive the following Treatment Arm 1 standard therapy 5-Fluorouracil Epirubicin and Cyclophosphamide day 1 every 3 weeks per three cycles Treatment Arm 2 Patients with low levels of BRCA1 mRNA will receive Epirubicin and Cisplatin day 1 every 3 weeks and 5-Fluorouracil for three cycles And patients with high levels of BRCA1 will receive docetaxel day 1 every three weeks per three cycles Definitive surgery will be performed within 4 weeks after the last cycle
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None