None listed
Conditions
Brief summary
Who is it for? You may be eligible for this trial is you are a female over the age of 50 who has been diagnosed with early-stage breast cancer and will be undergoing radiotherapy following surgery for early-stage breast cancer. Study details All participants in this study will receive a type of breast cancer treatment called Accelerated Partial Breast Irradiation (APBI) using a method called Volumetric Modulated Arc Therapy (VMAT). Only the part of the breast where the cancer has been surgically removed will receive radiotherapy (partial breast irradiation or “PBI”) rather than the whole breast (whole breast irradiation). This approach can reduce the toxic effects of radiotherapy. The treatment starts within 12 weeks after breast-conserving surgery and involves a planning session with a CT scan to help plan the treatment, which takes about an hour. After this, participants will take part in five daily 15-minute treatment sessions over one week. Participants in this study will be randomly allocated to receive one of two doses of treatment (26 Gy or 30 Gy). All participants will then be followed up for 3 years to assess quality of life and if there are any recurrences of cancer. It is hoped that this study will help determine if participant quality of life is the same with a higher dose compared to a slightly lower dose. This will then help decide the best dose for future patients with early breast cancer.
Interventions
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. Session attendance is recorded automatically in the patient electronic medical record through the treatment record and verify system. A summary of these
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. Session attendance is recorded automatically in the patient electronic medical record through the treatment record and verify system. A summary of these data will be captured in the trial database in a case report form. Arm A Total dose of 30 Gy will be delivered in five consecutive daily fractions. 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.
Sponsors
Integrated Clinical Oncology Network PTY Ltd (ICON)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Aged greater than or equal to 50 years old - Histologically confirmed Infiltrating ductal carcinoma (IDC) or pure DCIS, less than or equal to 20mm maximum size. - Lobular carcinoma in situ (LCIS) is permitted. - Histologic grade I or II - Estrogen receptor (ER) +/- progesterone receptor (PR) positive in greater than or equal to 10% of cells and HER2 receptor-negative. - Tumour bed identifiable on imaging via surgical clips - Clear surgical margins - Sentinel nodes negative (at least one node taken if invasive and no isolated tumour cells) - No evidence of distant metastasis
Exclusion criteria
- Ink on surgical margins or positive histological margins - Lymphatic vessel invasion (LVI) - Bilateral breast cancer - Invasive lobular carcinoma - Pleomorphic LCIS - Multifocal or multicentric invasive cancer - Invasive carcinoma with associated DCIS greater than or equal to 30mm. - Patients receiving neoadjuvant chemotherapy, anti-HER2 agents or endocrine therapy - Patients receiving adjuvant chemotherapy or anti-HER2 agents. - Previous Hodgkin’s lymphoma requiring mantle radiation - Prior radiation therapy to the ipsilateral breast - Triple-negative breast cancer - Documented mutation of BRCA1, BRCA2 or TP53, or at high genetic risk of breast cancer - Known inflammatory conditions associated with higher complications after RT, such as active scleroderma, systemic lupus erythematosus (requiring steroids or immune suppressive therapy) - Oncoplastic surgery where the primary tumour site is difficult to delineate - No previous cancer (except BCC or SCC of the skin) unless in remission beyond five years of diagnosis - People who are pregnant or planning to become pregnant - People who are unable or unwilling to comply with protocol requirements.
Outcome results
None listed