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

NCT03948568 | Completed Phase 4

• 1 other identifier: OTT 18-02
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Early-stage Breast Cancer

Keywords

Radiation Therapy; Endocrine Therapy

Outcome Measures

Primary Outcomes (1)

• Endocrine toxicity

  To measure endocrine toxicity. The Functional Assessment of Cancer Therapy - Endocrine Sub-scale (FACT-ES) is a questionnaire specific to patients with endocrine symptoms and measures the side effects and putative benefits of hormonal treatments given (endocrine therapy) in breast cancer. The FACT-ES questionnaire is comprised of 5 sections; physical well-being (7 questions), social/family well-being (7 questions), emotional well-being (6 questions), functional well-being (7 questions) and additional concerns (19 questions). A total of 46 questions are asked that all contain an answer on a scale range of 0-4, with 0 representing the answer 'not at all' and 4 representing the answer 'very much'. Of the 46 questions asked 31/46 have 'very much' representing the worst answer and the remaining 15/46 have 'very much' representing the best answer.

  12 months (+/- 2 weeks) post final fraction of radiotherapy

Secondary Outcomes (5)

• Radiotherapy toxicity

  12 months (+/- 2 weeks) post final fraction of radiotherapy

• Rates of starting endocrine therapy and compliance

  12 months (+/- 2 weeks) post final fraction of radiotherapy

• Direct Estimation of Health Utility Values

  12 months (+/- 2 weeks) post final fraction of radiotherapy

• Incremental cost-effectiveness ratios

  12 months (+/- 2 weeks) post final fraction of radiotherapy

• Exploratory analyses on evaluating radiotherapy toxicity

  12 months (+/- 2 weeks) post final fraction of radiotherapy

Study Arms (2)

Concurrent Endocrine Therapy and Radiotherapy

ACTIVE COMPARATOR

Concurrent endocrine therapy and radiotherapy. Concurrent endocrine therapy will be defined as, the commencement of endocrine therapy around 2 weeks before (a minimum of 1 week before to a maximum of 4 weeks) commencement of radiotherapy and continued throughout radiotherapy.

Combination Product: Endocrine Therapy and Radiotherapy

Sequential Endocrine Therapy after Radiotherapy

ACTIVE COMPARATOR

Sequential endocrine therapy after radiotherapy. Using the pragmatic definition sequential endocrine therapy should commence around 2 weeks (minimum 1 week, maximum 4 weeks) after the last fraction of radiotherapy.

Combination Product: Endocrine Therapy and Radiotherapy

Interventions

Endocrine Therapy and Radiotherapy COMBINATION_PRODUCT

Endocrine therapy and radiotherapy administered either concurrently or sequentially

Also known as: Radiotherapy, Tamoxifen, Letrozole, Anastrozole, Exemestane

Concurrent Endocrine Therapy and Radiotherapy; Sequential Endocrine Therapy after Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly diagnosed early stage, hormone receptor positive breast cancer
• Planned to receive both endocrine therapy and post-operative radiotherapy
• Able to provide verbal consent

You may not qualify if:

• Previous endocrine therapy for invasive breast cancer
• Previous radiotherapy for breast cancer in the same breast

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8M2, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy; Tamoxifen; Letrozole; Anastrozole; exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jean Marc Bourque, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

• Sharon McGee, MD

  Ottawa Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: May 14, 2019
• Study Start: September 17, 2019
• Primary Completion: June 9, 2021
• Study Completion: April 9, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-09

Locations

CA (1)