Ignite Creation Date:
2025-12-24 @ 3:42 PM
Ignite Modification Date:
2025-12-29 @ 7:54 AM
Study NCT ID:
NCT04540692
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2020-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Sequencing of Anthracyclines and Taxanes for Locally Advanced HER2-negative Breast Cancer
Sponsor:
Latin American Cooperative Oncology Group
Organization:
Study Overview
Official Title:
NEOSAMBA Clinical Trial - Stage I
Status:
RECRUITING
Status Verified Date:
2024-06
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:
NEOSAMBA
Brief Summary:
Phase III randomized clinical trial evaluating the sequencing of anthracyclines and taxanes in neoadjuvant therapy for locally advanced HER2-negative breast cancer.
Detailed Description:
Multicenter, phase III, open-label, randomized clinical trial, which will include 494 patients randomized to two neoadjuvant chemotherapy arms. The treatment protocol will be the same in both groups, only the regimens sequences will be evaluated: starting with anthracycline versus taxane, with or without carboplatin for patients with triple negative subtype. The chemotherapy regimen will follow the institution's routine, which includes the use of CA in the anthracyclical phase and, in the taxane phase, the use of docetaxel every 21 days or weekly paclitaxel. The rest of the treatment (surgery, radiotherapy, hormone therapy) will not be part of the study and will be carried out according to institutional guidelines.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| LACOG 0419 | OTHER | LACOG | View |