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出境医 / 临床实验 / Evaluating Optimal Timing of Endocrine Therapy and Radiation Therapy in Early-stage Breast Cancer (REaCT-RETT) (REaCT-RETT)
Evaluating Optimal Timing of Endocrine Therapy and Radiation Therapy in Early-stage Breast Cancer (REaCT-RETT) (REaCT-RETT)
Study Description
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Early-stage Breast Cancer | Combination Product: Endocrine Therapy and Radiotherapy | Phase 4 |
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.
Study Design
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 231 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Pragmatic Randomised, Multicentre Trial Evaluating Optimal Timing of Endocrine Therapy and Radiation Therapy in Early-stage Breast Cancer (REaCT-RETT) |
| Actual Study Start Date : | September 17, 2019 |
| Estimated Primary Completion Date : | August 2022 |
| Estimated Study Completion Date : | August 2024 |
Arms and Interventions
| Arm | Intervention/treatment |
|---|---|
|
Active Comparator: Concurrent Endocrine Therapy and Radiotherapy
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.
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Combination Product: Endocrine Therapy and Radiotherapy
Endocrine therapy and radiotherapy administered either concurrently or sequentially
Other Names:
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Active Comparator: Sequential Endocrine Therapy after Radiotherapy
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
Endocrine therapy and radiotherapy administered either concurrently or sequentially
Other Names:
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Outcome Measures
Primary Outcome Measures :
- Endocrine toxicity [ Time Frame: 12 months (+/- 2 weeks) post final fraction of radiotherapy ]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 :
- Radiotherapy toxicity [ Time Frame: 12 months (+/- 2 weeks) post final fraction of radiotherapy ]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.
- Rates of starting endocrine therapy and compliance [ Time Frame: 12 months (+/- 2 weeks) post final fraction of radiotherapy ]Rates of starting endocrine therapy, compliance rates, discontinuation rates, along with the reasons for discontinuation.
- Direct Estimation of Health Utility Values [ Time Frame: 12 months (+/- 2 weeks) post final fraction of radiotherapy ]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.
- Incremental cost-effectiveness ratios [ Time Frame: 12 months (+/- 2 weeks) post final fraction of radiotherapy ]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.
- Exploratory analyses on evaluating radiotherapy toxicity [ Time Frame: 12 months (+/- 2 weeks) post final fraction of radiotherapy ]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.
Eligibility Criteria
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Locations
| Canada, Ontario | |
| Ottawa Hospital Research Institute | |
| Ottawa, Ontario, Canada, K1H 8M2 | |
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
| Principal Investigator: | Jean Marc Bourque, MD | Ottawa Hospital Research Institute | |
| Principal Investigator: | Sharon McGee, MD | Ottawa Hospital Research Institute |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | April 18, 2019 | ||||||
| First Posted Date ICMJE | May 14, 2019 | ||||||
| Last Update Posted Date | January 22, 2021 | ||||||
| Actual Study Start Date ICMJE | September 17, 2019 | ||||||
| Estimated Primary Completion Date | August 2022 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
Endocrine toxicity [ Time Frame: 12 months (+/- 2 weeks) post final fraction of radiotherapy ] 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.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Evaluating Optimal Timing of Endocrine Therapy and Radiation Therapy in Early-stage Breast Cancer (REaCT-RETT) | ||||||
| Official Title ICMJE | A Pragmatic Randomised, Multicentre Trial Evaluating Optimal Timing of Endocrine Therapy and Radiation Therapy in Early-stage Breast Cancer (REaCT-RETT) | ||||||
| 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. | ||||||
| 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. | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 4 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Early-stage Breast Cancer | ||||||
| Intervention ICMJE | Combination Product: Endocrine Therapy and Radiotherapy
Endocrine therapy and radiotherapy administered either concurrently or sequentially
Other Names:
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||
| Estimated Enrollment ICMJE |
231 | ||||||
| Original Estimated Enrollment ICMJE |
218 | ||||||
| Estimated Study Completion Date ICMJE | August 2024 | ||||||
| Estimated Primary Completion Date | August 2022 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | Canada | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03948568 | ||||||
| Other Study ID Numbers ICMJE | OTT 18-02 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE | Not Provided | ||||||
| Responsible Party | Ottawa Hospital Research Institute | ||||||
| Study Sponsor ICMJE | Ottawa Hospital Research Institute | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
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| PRS Account | Ottawa Hospital Research Institute | ||||||
| Verification Date | January 2021 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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