BOOG 2017-03: Endocrine Therapy Plus CDK 4/6 Inhibition in First- or Second-line for Hormone Receptor Positive Advanced Breast Cancer - the SONIA Study

NCT03425838 Phase 3 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Borstkanker Onderzoek Groep
Phase	Phase 3
Status	ACTIVE_NOT_RECRUITING
Enrolment	1050
Start date	2017-11-09
Completion	2025-12

Conditions

• Breast Neoplasm Female

Interventions

• CDK 4/6 inhibitor
• Non-Steroidal Aromatase Inhibitor
• Fulvestrant

Primary outcomes

• PFS2 — Until objective disease progression, symptomatic deterioration, or unacceptable toxicity on second line treatment, death, strategy violation, or withdrawal of consent, whichever occurs first, assessed up to 60 months
  Progression-free survival after two lines of treatment (PFS2)

Countries

Netherlands