Ignite Creation Date:
2024-05-06 @ 1:31 AM
Last Modification Date:
2024-10-26 @ 11:05 AM
Study NCT ID:
NCT01822314
Status:
COMPLETED
Last Update Posted:
2024-03-07
First Post:
2013-03-25
Brief Title:
Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer
Sponsor:
Fondazione Michelangelo
Organization:
Fondazione Michelangelo
Study Overview
Official Title:
Neoadjuvant Chemotherapy With Nab-paclitaxel in Women With HER2-negative High-risk Breast Cancer ETNA Evaluating Treatment With Neoadjuvant Abraxane
Status:
COMPLETED
Status Verified Date:
2024-03
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:
ETNA
Brief Summary:
The purpose of this study is to assess the efficacy of neoadjuvant weekly nab-paclitaxel followed by Adriamycin Cyclophosphamide AC or Epirubicin Cyclophosphamide EC or FluorouracilEpirubicinCyclophosphamide FECcompared with neoadjuvant weekly solvent-based paclitaxel followed by AC or EC or FEC in terms of rate of pathological complete remissions at surgery
Detailed Description:
In this study eligible and consenting patients will be randomized to receive either 4 cycles of weekly abraxane nab-paclitaxel followed by 4 cycles of an anthracycline-containing regimen or 4 cycles of weekly paclitaxel followed by 4 cycles of an anthracycline-containing regimenThe anthracycline regimen AC EC or FEC will be chosen by the investigator at the participating sites
Before randomization patients will be stratified according to Disease stage operable tumor stage T2N0-1 T3N0 and locally advanced T3N1T4 any N2-3 and Tumor subtype luminal B intermediate HER2 negative ER or PGR positive Ki67 from 14 to 20 vs luminal B high HER2 negative ER or PGR positive Ki67 20 vs triple negative tumors HER2 negative ER negative and PgR negative Ki67 any value Tumor subtype will be confirmed at two selected referral laboratories
Neoadjuvant chemotherapy will be followed by definite surgery and irradiation as per international and local guidelines
During neoadjuvant chemotherapy patients will be assessed for safety and efficacy as detailed in the protocol
After definite surgery patients will be followed for approximately 10 years according to local procedures
Before randomization patients will be stratified according to Disease stage operable tumor stage T2N0-1 T3N0 and locally advanced T3N1T4 any N2-3 and Tumor subtype luminal B intermediate HER2 negative ER or PGR positive Ki67 from 14 to 20 vs luminal B high HER2 negative ER or PGR positive Ki67 20 vs triple negative tumors HER2 negative ER negative and PgR negative Ki67 any value Tumor subtype will be confirmed at two selected referral laboratories
Neoadjuvant chemotherapy will be followed by definite surgery and irradiation as per international and local guidelines
During neoadjuvant chemotherapy patients will be assessed for safety and efficacy as detailed in the protocol
After definite surgery patients will be followed for approximately 10 years according to local procedures
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2012-003481-41 | EUDRACT_NUMBER | None | None |