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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06909032




Registration number
NCT06909032
Ethics application status
Date submitted
27/03/2025
Date registered
3/04/2025
Date last updated
3/04/2025

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 0 0
23.05
Universal Trial Number (UTN)
Trial acronym
PUMA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - Accelerated partial breast irradiation

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

Active comparator: Arm B: Hypofractionated PBI delivering a total dose of 26 Gy in five consecutive daily fractions. - 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: Other: Accelerated partial breast irradiation
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.
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Patient-reported breast-related cosmetic outcome,
Assessment method [1] 0 0
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).
Timepoint [1] 0 0
36 months post randomisation
Secondary outcome [1] 0 0
Patient-reported breast-related cosmetic outcome
Assessment method [1] 0 0
BCTOS-12 aesthetic sub-scale scores
Timepoint [1] 0 0
Baseline, 8 weeks post-treatment, 6, 12, 18, 24 and 36-months post randomisation.
Secondary outcome [2] 0 0
Patient-reported breast-related functional outcome
Assessment method [2] 0 0
BCTOS-12 functional sub-scale scores
Timepoint [2] 0 0
Baseline, 8 weeks post-treatment, 6, 12, 18, 24 and 36-months post randomisation.
Secondary outcome [3] 0 0
Patient-reported quality of life
Assessment method [3] 0 0
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
Timepoint [3] 0 0
Baseline, 8 weeks post-treatment, 6, 12, 18, 24 and 36-months post randomisation.
Secondary outcome [4] 0 0
Ipsilateral breast tumour recurrence (IBTR)
Assessment method [4] 0 0
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).
Timepoint [4] 0 0
Up to 36 months post-randomisation
Secondary outcome [5] 0 0
Regional Recurrence
Assessment method [5] 0 0
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).
Timepoint [5] 0 0
Up to 36 months post-randomisation
Secondary outcome [6] 0 0
Locoregional disease recurrence
Assessment method [6] 0 0
Cumulative incidence of IBTR plus any recurrence in the ipsilateral axillary, supraclavicular or internal mammary chain
Timepoint [6] 0 0
Up to 36 months post-randomisation
Secondary outcome [7] 0 0
Distant disease recurrence
Assessment method [7] 0 0
Cumulative incidence of metastases to distant organs or bone sites measured using results from standard of care imaging (mammogram, ultrasound, MRI).
Timepoint [7] 0 0
Upto 36 months post-randomisation
Secondary outcome [8] 0 0
Patterns of care for treatment of disease recurrence (IBTR, locoregional, or metastatic)
Assessment method [8] 0 0
Documented in patients' medical records
Timepoint [8] 0 0
Upto 36 months post-randomisation
Secondary outcome [9] 0 0
Patient satisfaction with treatment
Assessment method [9] 0 0
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."
Timepoint [9] 0 0
At 8-weeks and 12 months post-treatment.

Eligibility
Key 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
Minimum age
50 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2032
Actual
Sample size
Target
168
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
Icon Cancer Centre Wahroonga - Wahroonga
Recruitment hospital [2] 0 0
Icon Cancer Centre Windsor Gardens - Windsor Gardens
Recruitment postcode(s) [1] 0 0
2076 - Wahroonga
Recruitment postcode(s) [2] 0 0
5087 - Windsor Gardens

Funding & Sponsors
Primary sponsor type
Other
Name
Integrated Community Oncology Network
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Icon Cancer Foundation (ICF)
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
John Boyages, MB BS(Hons), FRANZCR, PhD, AM
Address 0 0
Integrated Community Oncology Network
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
John Boyages, MB BS(Hons), FRANZCR, PhD, AM
Address 0 0
Country 0 0
Phone 0 0
+612 9480 4200
Email 0 0
John.Boyages@icon.team
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06909032