Clinical Trials /

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

NCT03948568

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 4

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: OTT 18-02
  • NCT ID: NCT03948568

Conditions

  • Early-stage Breast Cancer

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Concurrent Endocrine Therapy and RadiotherapyActive ComparatorConcurrent 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.
    Sequential Endocrine Therapy after RadiotherapyActive ComparatorSequential 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.

      Eligibility Criteria

              Inclusion Criteria:
      
                -  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
      
              Exclusion Criteria:
      
                -  Previous endocrine therapy for invasive breast cancer
      
                -  Previous radiotherapy for breast cancer in the same breast
            
      Maximum Eligible Age:N/A
      Minimum Eligible Age:18 Years
      Eligible Gender:All
      Healthy Volunteers:No

      Primary Outcome Measures

      Measure:Endocrine toxicity
      Time Frame:12 months (+/- 2 weeks) post final fraction of radiotherapy
      Safety Issue:
      Description: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.

      Secondary Outcome Measures

      Measure:Radiotherapy toxicity
      Time Frame:12 months (+/- 2 weeks) post final fraction of radiotherapy
      Safety Issue:
      Description:To evaluate the acute and early-moderate late toxicities of radiotherapy in terms of skin toxicity, pneumonitis, and breast pain. This will be recorded using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, with breast cosmesis recorded as per the European Organisation for Research and Treatment of Cancer (EORTC) cosmetic rating system for breast cancer. These standardized criteria have been used in a recent Canadian breast radiation randomized trial, RAPID, and the investigators will use a similar template to record any radiation toxicities at different points of time.
      Measure:Rates of starting endocrine therapy and compliance
      Time Frame:12 months (+/- 2 weeks) post final fraction of radiotherapy
      Safety Issue:
      Description:Rates of starting endocrine therapy, compliance rates, discontinuation rates, along with the reasons for discontinuation.
      Measure:Direct Estimation of Health Utility Values
      Time Frame:12 months (+/- 2 weeks) post final fraction of radiotherapy
      Safety Issue:
      Description:To measure the patient quality of life using the validated FACT-B questionnaire. The Functional Assessment of Cancer Therapy for Breast Cancer (FACT-B) is a questionnaire that measures multidimensional quality of life in patients with breast cancer. The FACT-B 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 (10 questions). A total of 37 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 20/37 have 'very much' representing the worst answer and the remaining 17/37 have 'very much' representing the best answer.
      Measure:Incremental cost-effectiveness ratios
      Time Frame:12 months (+/- 2 weeks) post final fraction of radiotherapy
      Safety Issue:
      Description:Incremental cost-effectiveness ratios (cost per one quality-adjusted life year (QALY) gained and cost per one endocrine toxicity case averted) will be measured using the EQ-5D-5L questionnaire. The EuroQol 5 Dimension 5 Level (EQ-5D-5L) questionnaire consists of two sections; the descriptive system and the visual analogue scale. The descriptive system comprises 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and has 5 levels associated with it (no problems, slight problems, moderate problems, severe problems and extreme problems). The scale range of 1-5 is used for the 5 dimensions where 1 is the best outcome and 5 is the worst outcome. The Visual Analogue scale records the respondent's self-rated health on a vertical, visual scale with endpoints labelled "the best health you can imagine" at the top and "the worst health you can imagine" at the bottom. This ranges 0-100 with 0 being the worst outcome and 100 being the best outcome.
      Measure:Exploratory analyses on evaluating radiotherapy toxicity
      Time Frame:12 months (+/- 2 weeks) post final fraction of radiotherapy
      Safety Issue:
      Description:Exploratory analyses will be performed evaluating toxicity in patients receiving different types of radiotherapy (i.e. local versus regional radiotherapy). This will be evaluated using data collected on breast volume, seroma size, dose heterogeneity and the time of stimulation and planning.

      Details

      Phase:Phase 4
      Primary Purpose:Interventional
      Overall Status:Recruiting
      Lead Sponsor:Ottawa Hospital Research Institute

      Trial Keywords

      • Radiation Therapy
      • Endocrine Therapy

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