Ignite Creation Date:
2024-05-06 @ 12:36 PM
Last Modification Date:
2024-10-26 @ 1:01 PM
Study NCT ID:
NCT03809988
Status:
COMPLETED
Last Update Posted:
2023-09-07
First Post:
2019-01-15
Brief Title:
PALbociclib Rechallenge in horMone Receptor-posItiveHER2- Negative Advanced Breast Cancer PALMIRA
Sponsor:
MedSIR
Organization:
MedSIR
Study Overview
Official Title:
InternationalMulticenterRandomizedOpen-label Phase II to Evaluate the Efficacy and Safety of Continuation of Palbociclib2nd Line Endocrine Therapy in HRHER2- ABC Patients Who Had Clinical Benefit During 1st Line Palbociclib
Status:
COMPLETED
Status Verified Date:
2023-09
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:
PALMIRA
Brief Summary:
Hormone Receptor HR-positiveHuman Epidermal Growth Factor Receptor 2 HER2-negative advanced breast cancer ABC
Detailed Description:
Pre- and post-menopausal women age 18 years with HR-positive and HER2-negative with ABC that had previously received first-line endocrine therapy in combination with palbociclib and had achieved clinical benefit during palbociclib-based treatment Patients relapsing on a palbociclib-based regimen in the adjuvant setting are also eligible Patients are not eligible if they are candidates for a local treatment with a curative intention Evidence of either measurable and biopsiable metastatic disease as for Response Evaluation Criteria In Solid Tumors RECIST v11 or non-measurable disease with bone lesion is required Pre-menopausal women must be under treatment with luteinizing hormone-releasing hormone LHRH analogues
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-002781-48 | EUDRACT_NUMBER | None | None |