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

NCT06909032 | Not Yet Recruiting

• 1 other identifier: 23.05
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Breast Cancer

Keywords

Partial breast irradiation (PBI); Patient reported outcomes; Breast cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (9)

• Patient-reported breast-related cosmetic outcome

  Baseline, 8 weeks post-treatment, 6, 12, 18, 24 and 36-months post randomisation.

• Patient-reported breast-related functional outcome

  Baseline, 8 weeks post-treatment, 6, 12, 18, 24 and 36-months post randomisation.

• Patient-reported quality of life

  Baseline, 8 weeks post-treatment, 6, 12, 18, 24 and 36-months post randomisation.

• Ipsilateral breast tumour recurrence (IBTR)

  Up to 36 months post-randomisation

• Regional Recurrence

  Up to 36 months post-randomisation

Study Arms (2)

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.

Radiation: Accelerated partial breast irradiation

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.

Radiation: Accelerated partial breast irradiation

Interventions

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.

Arm A: Hypofractionated PBI delivering a total dose of 30 Gy in five consecutive daily fractions.; Arm B: Hypofractionated PBI delivering a total dose of 26 Gy in five consecutive daily fractions.

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Integrated Community Oncology Network: lead
• Icon Cancer Foundation (ICF): collaborator

Study Sites (2)

Icon Cancer Centre Wahroonga

Wahroonga, New South Wales, 2076, Australia

Location

Icon Cancer Centre Windsor Gardens

Windsor Gardens, South Australia, 5087, Australia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• John Boyages, MB BS(Hons), FRANZCR, PhD, AM

  Integrated Community Oncology Network

  STUDY CHAIR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2025
• First Posted: April 3, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): December 1, 2032
• Last Updated: April 3, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (2)