Status:
NOT_YET_RECRUITING
Accelerated Partial Breast Irradiation Using External Beam Volumetric Modulated Arc Therapy (VMAT): a Randomised Non-inferiority Trial of 30 Gy Versus 26 Gy in Five Fractions Investigating Patient-reported Outcomes
Lead Sponsor:
Integrated Community Oncology Network
Collaborating Sponsors:
Icon Cancer Foundation (ICF)
Conditions:
Breast Cancer
Eligibility:
FEMALE
50+ years
Phase:
NA
Brief Summary
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 radiati...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2032
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT06909032
Start Date
April 1 2025
End Date
December 1 2032
Last Update
April 3 2025
Active Locations (2)
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1
Icon Cancer Centre Wahroonga
Wahroonga, New South Wales, Australia, 2076
2
Icon Cancer Centre Windsor Gardens
Windsor Gardens, South Australia, Australia, 5087