Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06016738
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2023-08-17
Brief Title:
OP-1250 Palazestrant vs Standard of Care for the Treatment of ERHER2- Advanced Breast Cancer
Sponsor:
Olema Pharmaceuticals Inc
Organization:
Olema Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 3 Randomized Open-Label Study of OP-1250 Monotherapy vs Standard of Care for the Treatment of ER HER2- Advanced or Metastatic Breast Cancer Following Endocrine and CDK 46 Inhibitor Therapy OPERA-01
Status:
RECRUITING
Status Verified Date:
2024-10
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:
OPERA-01
Brief Summary:
This phase 3 clinical trial compares the safety and efficacy of palazestrant OP-1250 to the standard-of-care options of fulvestrant or an aromatase inhibitor in women and men with breast cancer whose disease has advanced on one endocrine therapy in combination with a CDK46 inhibitor
Detailed Description:
This is an international multicenter randomized open-label active-controlled phase 3 clinical trial The purpose of this trial is to compare the safety and efficacy of palazestrant OP-1250 as a single agent to the standard of care endocrine therapy either fulvestrant or an aromatase inhibitor anastrozole letrozole or exemestane
This trial is seeking adult participants with ER HER2- advanced or metastatic breast cancer whose disease has relapsed or progressed on 1 or 2 prior lines of standard-of-care endocrine therapy for metastatic breast cancer Prior lines of therapy must include one line of endocrine therapy in combination with a CDK 46 inhibitor In the dose-selection part of the trial approximately 120 participants will be randomized to one of the two doses of palazestrant or to the standard-of-care endocrine therapy Thereafter approximately 390 participants will be randomized to palazestrant at the selected dose or to the standard-of-care endocrine therapy
This trial is seeking adult participants with ER HER2- advanced or metastatic breast cancer whose disease has relapsed or progressed on 1 or 2 prior lines of standard-of-care endocrine therapy for metastatic breast cancer Prior lines of therapy must include one line of endocrine therapy in combination with a CDK 46 inhibitor In the dose-selection part of the trial approximately 120 participants will be randomized to one of the two doses of palazestrant or to the standard-of-care endocrine therapy Thereafter approximately 390 participants will be randomized to palazestrant at the selected dose or to the standard-of-care endocrine therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OPERA-01 | OTHER | Olema Pharmaceuticals Inc | None |