Ignite Creation Date:
2024-05-06 @ 1:33 PM
Last Modification Date:
2024-10-26 @ 1:16 PM
Study NCT ID:
NCT04055493
Status:
RECRUITING
Last Update Posted:
2023-05-15
First Post:
2019-07-22
Brief Title:
Adj Marker-adjusted Personalized Therapy Comparing ETRibociclib vs Chemotherapy in Intermediate Risk HRHER2- EBC
Sponsor:
West German Study Group
Organization:
West German Study Group
Study Overview
Official Title:
Adjuvant Dynamic Marker - Adjusted Personalized Therapy Comparing Endocrine Therapy Plus Ribociclib Versus Chemotherapy in Intermediate Risk HRHER2- Early Breast Cancer
Status:
RECRUITING
Status Verified Date:
2023-05
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:
ADAPTcycle
Brief Summary:
The study investigates whether the patient group with intermediate-risk early breast cancer benefits from treatment with ribociclib in combination with endocrine therapy compared to standard-of-care chemotherapy followed by adjuvant endocrine therapy
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 very positive national and international feedback to the ADAPT concept as a whole
The aim of this ADAPTcycle phase-III-trial is to investigate whether the intermediate-risk patient group identified during the screening phase derives additional benefit from treatment with ribociclib in combination with ET compared to chemotherapy followed by adjuvant ET
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 very positive national and international feedback to the ADAPT concept as a whole
The aim of this ADAPTcycle phase-III-trial is to investigate whether the intermediate-risk patient group identified during the screening phase derives additional benefit from treatment with ribociclib in combination with ET compared to chemotherapy followed by adjuvant ET
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