Ignite Creation Date:
2024-05-06 @ 7:18 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02511639
Status:
COMPLETED
Last Update Posted:
2020-12-03
First Post:
2015-07-16
Brief Title:
Maintenance Aromatase Inhibitors AIs Everolimus vs AIs in Hormone Receptor Positive Metastatic Breast Cancer Patients
Sponsor:
Istituto Oncologico Veneto IRCCS
Organization:
Istituto Oncologico Veneto IRCCS
Study Overview
Official Title:
MAINtenance Afinitor A Randomized Trial Comparing Maintenance Aromatase Inhibitors AIs Everolimus Afinitor vs AIs in Hormone Receptor Positive HR Metastatic Breast Cancer Patients With Disease Control After First Line Chemotherapy
Status:
COMPLETED
Status Verified Date:
2020-12
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:
MAIN-A
Brief Summary:
The purpose of this study is to compare maintenance Aromatase Inhibitors AIs everolimus with Aromatase Inhibitors alone after 1st line chemotherapy in patients with HR metastatic breast cancer
Detailed Description:
The purpose of this study is
to compare the progression free survival PFS of AIseverolimus to AIs administered as maintenance therapy in HR advanced breast cancer patients with disease control Complete Response CR Partial Response PR or Stable Disease SDafter 1st line chemotherapy
To evaluate the overall survival
To assess the safety profile
To evaluate the response rate
to compare the progression free survival PFS of AIseverolimus to AIs administered as maintenance therapy in HR advanced breast cancer patients with disease control Complete Response CR Partial Response PR or Stable Disease SDafter 1st line chemotherapy
To evaluate the overall survival
To assess the safety profile
To evaluate the response rate
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 |
|---|---|---|---|
| 2013-004153-24 | EUDRACT_NUMBER | None | None |