Selecteren van de optimale plaats van CDK4/6-remmer bij de behandeling van uitgezaaide hormoongevoelige (HR+) borstkanker: de SONIA studie

Completed

• Conditions: Mammary carcinoma; breast cancer; mammacarcinoom; borstkanker

• Registration Number: NL-OMON23699
• Lead Sponsor: BOOG study center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 1050

Inclusion Criteria

1. Adult women (≥ 18 years of age) with proven diagnosis of adenocarcinoma of the breast with loco-regional recurrent or metastatic disease not amenable to resection or radiation therapy with curative intent and for whom chemotherapy is not clinically indicated.

Exclusion Criteria

1. Patients with advanced, symptomatic, visceral spread, who are at risk of life-threatening complications in the short term.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Progression-free survival after two lines of treatment

Secondary Outcome Measures

Name	Time	Method
- Overall survival<br /><br>- Objective response<br /><br>- Quality of life<br /><br>- Cost-effectiveness<br>- Adverse events