Ignite Creation Date:
2024-05-06 @ 3:13 PM
Last Modification Date:
2024-10-26 @ 1:45 PM
Study NCT ID:
NCT04565054
Status:
RECRUITING
Last Update Posted:
2024-03-01
First Post:
2020-07-07
Brief Title:
Adjuvant Therapy With Abemaciclib SOC ET vs SOC ET in Clinical or Genomic High Risk HRHER2- EBC
Sponsor:
West German Study Group
Organization:
West German Study Group
Study Overview
Official Title:
Adj Dynamic Marker - Adjusted Personalized Therapy Comparing Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy in Clinical or Genomic High Risk HRHER2- EBC
Status:
RECRUITING
Status Verified Date:
2024-02
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:
ADAPTlate
Brief Summary:
Patients with breast cancer who have completed first line therapy eg radiotherapy chemotherapy surgery and who have to be identified with having a high risk of recurrence of cancer will be eligible for the study This patient group is currently offered a standard of care chemotherapy plus endocrine therapy ET The study investigates whether the patient group with high-risk early breast cancer benefits from treatment with the medication abemaciclib in combination with ET compared to ET alone
Detailed Description:
The WSG ADAPT trial program is one of the first new generation trials addressing the issue of individualization of neo-adjuvant decision-making in early breast cancer EBC in a subtype-specific manner The first WSG ADAPT umbrella trial NCT01779206 aimed to establish early predictive molecular surrogate markers for response after a short 3-week induction treatment
The goals of the WSG ADAPT trial program - early response assessment and subtype-specific therapy tailoring to those patients who are most likely to benefit - have contributed to the positive national and international feedback regarding the ADAPT-concept as a whole
The aim of this ADAPTlate phase-III-trial is to gain further knowledge of the group of patients at intermediate to high risk for disease recurrence who have completed definite locoregional therapy with or without neoadjuvant or adjuvant chemotherapy With ADAPTlate it is planned to investigate if the intermediate to high-risk patient group identified during the screening phase derives additional benefit from treatment with abemaciclib in combination with ET compared to ET alone
The goals of the WSG ADAPT trial program - early response assessment and subtype-specific therapy tailoring to those patients who are most likely to benefit - have contributed to the positive national and international feedback regarding the ADAPT-concept as a whole
The aim of this ADAPTlate phase-III-trial is to gain further knowledge of the group of patients at intermediate to high risk for disease recurrence who have completed definite locoregional therapy with or without neoadjuvant or adjuvant chemotherapy With ADAPTlate it is planned to investigate if the intermediate to high-risk patient group identified during the screening phase derives additional benefit from treatment with abemaciclib in combination with ET compared to ET alone
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 |
|---|---|---|---|
| 2019-001488-60 | EUDRACT_NUMBER | None | None |