Ignite Creation Date:
2024-05-06 @ 7:19 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02513394
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-24
First Post:
2015-07-29
Brief Title:
PALbociclib CoLlaborative Adjuvant Study
Sponsor:
Alliance Foundation Trials LLC
Organization:
Alliance Foundation Trials LLC
Study Overview
Official Title:
PALbociclib CoLlaborative Adjuvant Study A Randomized Phase III Trial of Palbociclib With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone for Hormone Receptor Positive HR Human Epidermal Growth Factor Receptor 2 HER2-Negative Early Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-04
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:
PALLAS
Brief Summary:
This is a prospective two arm international multicenter randomized open-label Phase III study evaluating the addition of 2 years of palbociclib to standard adjuvant endocrine therapy for patients with HR HER2- early breast cancer EBC
The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HRHER2- early breast cancer Assessment of a variety of correlative analysis including evaluation of the effect of palbociclib in genomically defined tumor subgroups is planned
The purpose of the PALLAS study is to determine whether the addition of palbociclib to adjuvant endocrine therapy will improve outcomes over endocrine therapy alone for HRHER2- early breast cancer Assessment of a variety of correlative analysis including evaluation of the effect of palbociclib in genomically defined tumor subgroups is planned
Detailed Description:
None
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 |
|---|---|---|---|
| ABCSG 42 | OTHER | None | None |
| BIG 14-03 | OTHER | None | None |
| 2014-005181-30 | EUDRACT_NUMBER | Breast International Group | None |