Clinical Trial: NCT03425838
Endocrine Therapy Plus CDK4/6 in First or Second Line for Hormone (SONIA) Receptor Positive Advanced Breast Cancer
Status:
ACTIVE NOT RECRUITINGPhase:
Phase 3| Lead Sponsor: | Borstkanker Onderzoek Groep |
| Information Provided By: | Borstkanker Onderzoek Groep |
| Last Update Posted: | 2026-05-20 |
Study Overview
Brief Summary
Given the uncertain benefit in efficacy of adding CDK 4/6 to first rather than second line endocrine treatment, the aim of this project is to evaluate whether the sequence of an aromatase inhibitor plus CDK 4/6 in first line followed by fulvestrant in second line is superior to the sequence of an aromatase inhibitor in first line followed by fulvestrant plus CDK4/6 in second line.
Official Title
Conditions
Intervention / Treatment
- Drug: CDK 4/6 inhibitor
- Drug: Non-Steroidal Aromatase Inhibitor
- Drug: Fulvestrant
Other Study ID Numbers
- BOOG 2017-03
- 2017-002334-23
- 2017
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Estimated)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Borstkanker Onderzoek Groep |
| Information Provided By: | Borstkanker Onderzoek Groep |
| Last Update Posted: | 2026-05-20 |
Study Overview
Brief Summary
Given the uncertain benefit in efficacy of adding CDK 4/6 to first rather than second line endocrine treatment, the aim of this project is to evaluate whether the sequence of an aromatase inhibitor plus CDK 4/6 in first line followed by fulvestrant in second line is superior to the sequence of an aromatase inhibitor in first line followed by fulvestrant plus CDK4/6 in second line.
Official Title
Conditions
Intervention / Treatment
- Drug: CDK 4/6 inhibitor
- Drug: Non-Steroidal Aromatase Inhibitor
- Drug: Fulvestrant
Other Study ID Numbers
- BOOG 2017-03
- 2017-002334-23
- 2017