NCT05416164

DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 595 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates whether radiotherapy can safely be omitted in breast cancer patients with T1-2N0 tumors who achieve a pathologic complete response after neoadjuvant systemic therapy and breast-conserving surgery

Detailed description

The proportion of women diagnosed with breast cancer who are treated with neoadjuvant systemic therapy is increasing. Depending on the subtype, 10-75% of these patients will have a pathologic complete response. Currently breast conserving surgery with pathologic complete response is followed by radiotherapy. In this patient group risk of local recurrence is low, but radiotherapy may cause considerable morbidity. The aim of this study is to investigate whether omitting radiotherapy is safe for patients with a node-negative breast tumor \<5cm treated with neoadjuvant systemic therapy and breast conserving surgery who achieve a pathologic complete response

Conditions

• Breast Cancer

Interventions

Type	Name	Description
RADIATION	Omission of radiotherapy	Omission of radiotherapy

Timeline

• Start date: 2022-10-07
• Primary completion: 2032-05-01
• Completion: 2037-05-01
• First posted: 2022-06-13
• Last updated: 2025-03-26

Locations

1 site across 1 country: Netherlands