Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-27 @ 7:06 AM
Study NCT ID:
NCT04142060
Status:
TERMINATED
Last Update Posted:
2022-10-28
First Post:
2019-10-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeting the PAM50 Her2-Enriched Phenotype With Enzalutamide in Hormone Receptor-Positive/Her2-Negative Metastatic BC
Sponsor:
SOLTI Breast Cancer Research Group
Organization:
Study Overview
Official Title:
Targeting the PAM50 Her2-Enriched Phenotype With Enzalutamide in Hormone Receptor-Positive/Her2-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 HR+/HER2-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 HR+/HER2-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 HR+/HER2-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:
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 |
|---|---|---|---|---|
| 2019-002806-28 | EUDRACT_NUMBER | None | View |