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| Name | Class |
|---|---|
| Icon Cancer Foundation | OTHER |
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For women undergoing radiotherapy following surgery for early-stage breast cancer, breast-related quality of life (BrQoL) is an important consideration. Treating only the part of the breast by radiation where the cancer has been surgically removed (partial breast irradiation or "PBI") rather than the whole breast (whole breast irradiation) can reduce the toxic effects of radiotherapy. This trial aims to evaluate whether there is a difference in patient-reported BrQoL between two total doses of radiation given in five treatments using PBI. If BrQOL for the higher dose of PBI is no worse than the lower dose, using the higher dose would be advised as best practice, given that it is more likely to be more effective in reducing the chance of cancer coming back in the breast than the lower dose.
Single-blind, phase III, multisite, randomised non-inferiority trial. PBI will be planned and treated as per the protocol using VMAT. The prescribed dose will be 30 Gy in 5 daily fractions (Arm A) or 26 Gy in 5 daily fractions (Arm B). Participants will be blinded to their treatment allocation.
Follow-up will be at the following time points:
Assessments to be conducted at each time point are:
Recruitment is planned for three years with a three-year follow-up period for all patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A: Hypofractionated PBI delivering a total dose of 30 Gy in five consecutive daily fractions. | Active Comparator | PBI will be delivered using a VMAT planning and delivery technique. Prior to treatment patients are required to attend a treatment planning session that will assist with planning the treatment. The planning procedure will take up to approximately 60 minutes and involve a computed-tomography (CT) scan with the patient positioned in the treatment position. Treatment is expected to take around 15 minutes per treatment. The intervention will be prescribed by a radiation oncologist and administered by radiation therapists. During treatment, imaging will be completed to ensure treatment is administered accurately. All patients will complete breast cancer related quality of life questionnaires. |
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| Arm B: Hypofractionated PBI delivering a total dose of 26 Gy in five consecutive daily fractions. | Active Comparator | The comparator for this study is another dose that is used as standard of care for APBI in Australia and globally. Planning and treatment procedures will be same as that for Arm A. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerated partial breast irradiation | Radiation | Accelerated partial breast irradiation (APBI) will be delivered using Volumetric Modulated Arc Therapy (VMAT). Treatment will be started within 12 weeks of breast conserving surgery and within four weeks of randomisation. Treatment will occur in five (5) once-daily sessions and should be completed within seven (7) days of starting radiotherapy. Two total doses of APBI will be compared: 30 Gy and 26 Gy. The aim is to determine whether quality of life is no worse when a higher dose of APBI is used compared to a slightly lower dose of APBI. The results of this study will help to guide doctors choose the best dose of APBI for patients with early breast cancer in the future. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported breast-related cosmetic outcome, | Proportion of patients with a moderate or worse adverse cosmetic outcome, defined as a score of greater than or equal to 2.5 on the aesthetic sub-scale of the Breast Cancer Treatment Outcome Scale-12 (BCTOS-12). | 36 months post randomisation |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported breast-related cosmetic outcome | BCTOS-12 aesthetic sub-scale scores | Baseline, 8 weeks post-treatment, 6, 12, 18, 24 and 36-months post randomisation. |
| Patient-reported breast-related functional outcome |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| John Boyages, MB BS(Hons), FRANZCR, PhD, AM | Contact | +612 9480 4200 | John.Boyages@icon.team | |
| Nitika Neha, MSc (Biotchnology) | Contact | +61 7 3737 4500 | research.iit@icon.team |
| Name | Affiliation | Role |
|---|---|---|
| John Boyages, MB BS(Hons), FRANZCR, PhD, AM | Integrated Community Oncology Network | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icon Cancer Centre Wahroonga | Wahroonga | New South Wales | 2076 | Australia |
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|
BCTOS-12 functional sub-scale scores
| Baseline, 8 weeks post-treatment, 6, 12, 18, 24 and 36-months post randomisation. |
| Patient-reported quality of life | BREAST-Q (V2.0) questionnaire scores for the following Breast Conserving Therapy (Post-operative) modules: - Physical well-being: chest - Satisfaction with breasts - Adverse effects of radiation - Fatigue - Impact on work | Baseline, 8 weeks post-treatment, 6, 12, 18, 24 and 36-months post randomisation. |
| Ipsilateral breast tumour recurrence (IBTR) | Cumulative incidence of local (true) recurrences of breast cancer within the index quadrant or newly diagnosed breast cancer within any other quadrant of the ipsilateral breast measured using results from standard of care imaging (mammogram, ultrasound, MRI). | Up to 36 months post-randomisation |
| Regional Recurrence | Cumulative incidence of any recurrence in the ipsilateral axillary, supraclavicular or internal mammary chain with or without recurrence in the breast or elsewhere measured using results from standard of care imaging (mammogram, ultrasound, MRI). | Up to 36 months post-randomisation |
| Locoregional disease recurrence | Cumulative incidence of IBTR plus any recurrence in the ipsilateral axillary, supraclavicular or internal mammary chain | Up to 36 months post-randomisation |
| Distant disease recurrence | Cumulative incidence of metastases to distant organs or bone sites measured using results from standard of care imaging (mammogram, ultrasound, MRI). | Upto 36 months post-randomisation |
| Patterns of care for treatment of disease recurrence (IBTR, locoregional, or metastatic) | Documented in patients' medical records | Upto 36 months post-randomisation |
| Patient satisfaction with treatment | Assessed qualitatively via an open-ended question: "Please write about your experience with breast cancer treatment, specifically focusing on your treatment with accelerated partial breast irradiation (APBI). Think about how you felt physically and emotionally and what the greatest challenges were during this time." | At 8-weeks and 12 months post-treatment. |
| Icon Cancer Centre Windsor Gardens | Windsor Gardens | South Australia | 5087 | Australia |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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