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 (PUMA)

Integrated Community Oncology Network

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Radiation: Accelerated partial breast irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT06909032

23.05

Details and patient eligibility

About

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.

Full 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 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:

• Eight weeks following the end of radiation
• Every six months post-randomisation for two years following randomisation
• Three years post-randomisation (final visit)

Assessments to be conducted at each time point are:

• Clinical assessment
• Completion of Patient-Reported Outcome Measures (PROMs)
• Mammogram and ultrasound (baseline and annually)
• Documentation of IBTR - classified as a true recurrence or Elsewhere
• Documentation of any other type of recurrence (regional, distant, opposite breast)

Recruitment is planned for three years with a three-year follow-up period for all patients.

Enrollment: 168 estimated patients

Sex: Female

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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168 participants in 2 patient groups

Arm A: Hypofractionated PBI delivering a total dose of 30 Gy in five consecutive daily fractions.

Active Comparator group

Description:

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.

Treatment:

Radiation: Accelerated partial breast irradiation

Arm B: Hypofractionated PBI delivering a total dose of 26 Gy in five consecutive daily fractions.

Active Comparator group

Description:

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.

Treatment:

Radiation: Accelerated partial breast irradiation