Ignite Creation Date:
2024-05-06 @ 1:51 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04142060
Status:
TERMINATED
Last Update Posted:
2022-10-28
First Post:
2019-10-25
Brief Title:
Targeting the PAM50 Her2-Enriched Phenotype With Enzalutamide in Hormone Receptor-PositiveHer2-Negative Metastatic BC
Sponsor:
SOLTI Breast Cancer Research Group
Organization:
SOLTI Breast Cancer Research Group
Study Overview
Official Title:
Targeting the PAM50 Her2-Enriched Phenotype With Enzalutamide in Hormone Receptor-PositiveHer2-Negative Metastatic Breast Cancer
Status:
TERMINATED
Status Verified Date:
2022-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of effectiveness
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ARIANNA
Brief Summary:
The main hypothesis of the study is that enzalutamide induces a significant proliferative arrest in HRHER2-negative breast cancer falling into the PAM50 HER2-E subtype Currently enzalutamide clinical development is ongoing in different prostate cancer indications but the breast cancer development program has been discontinued As the role of the AR in HR-positive breast cancer and the predictive value of previously identified biomarker are still unclear further research is needed to effectively utilize enzalutamide in this disease
Detailed Description:
A strong rationale accumulated over the years suggests that within HRHER2-negative breast cancer tumors falling into the PAM50 HER2-enriched subtype have androgen receptor AR-dependency To test this hypothesis directly in patients tumors we propose an exploratory open-label non-randomized two-cohort multicenter prospective phase II study which evaluates the effect of enzalutamide on proliferation after 2 weeks 14-21 days of treatment in patients with endocrine-resistant locally advanced or metastatic HRHER2-negative breast cancer After 2 weeks 14-21 days of treatment patients will continue enzalutamide Exemestane will be allowed to be added to enzalutamide per investigator discretion and will be administered until progression or unacceptable toxicity
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?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2019-002806-28 | EUDRACT_NUMBER | None | None |