NCT06476119

OPTImaL:Optimisation of Treatment for Patients With Low Stage Triple-negative Breast Cancer With High Stromal Tumor-infiltrating Lymphocytes

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 490 (estimated)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to investigate whether subjects with breast cancer that have certain favorable features, after performing the surgery and radiation, the chemotherapy can be safely omitted in the treatment. In addition, the investigation looks at whether the omission of chemotherapy ensures a better quality of life. Participants decide, in consultation with their treating physician, whether they choose to be treated with adjuvant chemotherapy or not.

Conditions

• Breast Cancer Stage I
• Triple Negative Breast Cancer (TNBC)

Interventions

Type	Name	Description
DRUG	Adjuvant chemotherapy	adjuvant chemotherapy according to local/ national guidelines
OTHER	No adjuvant chemotherapy	no adjuvant chemotherapy

Timeline

• Start date: 2025-04-15
• Primary completion: 2032-09-15
• Completion: 2034-09-15
• First posted: 2024-06-26
• Last updated: 2025-04-23

Locations

28 sites across 1 country: Netherlands