NCT03948568

Evaluating Optimal Timing of Endocrine Therapy and Radiation Therapy in Early-stage Breast Cancer (REaCT-RETT)

A Pragmatic Randomised, Multicentre Trial Evaluating Optimal Timing of Endocrine Therapy and Radiation Therapy in Early-stage Breast Cancer (REaCT-RETT)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 262 (actual)
• Sponsor: Ottawa Hospital Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

REaCT-RETT will demonstrate the non-inferiority of concurrent compared to sequential endocrine therapy in patients receiving post-operative radiotherapy for early stage breast cancer.

Detailed description

Clinical equipoise exists around the optimal time to start adjuvant endocrine therapy in patients who will receive post-operative radiotherapy for breast cancer. Patients receive either concurrent or sequential endocrine and radiation therapy, where concurrent therapy consists of endocrine therapy started before, with or during radiotherapy, while sequential treatment is defined as endocrine therapy starting after the completion of radiotherapy. A recent survey of Canadian oncologists showed that the main reason for prescribing sequential endocrine therapy was a concern that concurrent endocrine therapy and radiotherapy would worsen the toxicity of endocrine treatment. This is despite the absence of any clinical trial evidence to support this. Indeed, a recent systematic review by our group was unable to confirm or refute whether increased toxicities, related to the timing of endocrine therapy and radiotherapy actually exist in clinical practice. The investigators are therefore proposing a pragmatic randomised trial to assess whether or not concurrent endocrine therapy and radiotherapy worsens endocrine treatment-related symptoms in an era of modern endocrine and radiation therapy.

Conditions

• Early-stage Breast Cancer

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Endocrine Therapy and Radiotherapy	Endocrine therapy and radiotherapy administered either concurrently or sequentially

Timeline

• Start date: 2019-09-17
• Primary completion: 2021-06-09
• Completion: 2022-04-09
• First posted: 2019-05-14
• Last updated: 2022-09-30

Locations

1 site across 1 country: Canada