Breast CancerPUMANCT06909032
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
A study testing Accelerated partial breast irradiation in people with Breast Cancer, run by Integrated Community Oncology Network at 2 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Accelerated partial breast irradiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 2 sitesAustralia
- Study dates
- Apr 2025to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- Clear surgical margins
- Sentinel nodes negative (at least one node taken if invasive and no isolated tumour cells)
- No evidence of distant metastasis
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites
Icon Cancer Centre Wahroonga
Wahroonga, New South Wales, 2076
John Boyages, MBBS(Hons), FRANZCR, PhD, +612 9480 4200, john.boyages@icon.team
Icon Cancer Centre Windsor Gardens
Windsor Gardens, South Australia, 5087
Scott Curruthers, MBBS, FRANZCR, +61 8 8164 3600, Scott.Carruthers@icon.team
About this study
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.
Read the 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 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.
- Conditions
- Breast Cancer
- Being tested
- Accelerated partial breast irradiation
- Keywords
- Partial breast irradiation (PBI), Patient reported outcomes, Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated partial breast irradiationRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Radiation: Accelerated partial breast irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 36 months post randomisation
Secondary outcomes (9)
Patient-reported breast-related cosmetic outcome
BCTOS-12 aesthetic sub-scale scores
Measured: Baseline, 8 weeks post-treatment, 6, 12, 18, 24 and 36-months post randomisation.
Patient-reported breast-related functional outcome
BCTOS-12 functional sub-scale scores
Measured: Baseline, 8 weeks post-treatment, 6, 12, 18, 24 and 36-months post randomisation.
Patient-reported quality of life
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
Measured: Baseline, 8 weeks post-treatment, 6, 12, 18, 24 and 36-months post randomisation.
Ipsilateral breast tumour recurrence (IBTR)
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).
Measured: Up to 36 months post-randomisation
Regional Recurrence
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).
Measured: Up to 36 months post-randomisation
Locoregional disease recurrence
Cumulative incidence of IBTR plus any recurrence in the ipsilateral axillary, supraclavicular or internal mammary chain
Measured: Up to 36 months post-randomisation
Distant disease recurrence
Cumulative incidence of metastases to distant organs or bone sites measured using results from standard of care imaging (mammogram, ultrasound, MRI).
Measured: Upto 36 months post-randomisation
Patterns of care for treatment of disease recurrence (IBTR, locoregional, or metastatic)
Documented in patients' medical records
Measured: Upto 36 months post-randomisation
Patient satisfaction with treatment
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."
Measured: At 8-weeks and 12 months post-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Integrated Community Oncology Network
- Sponsor type
- University, hospital or other
- Collaborators
- Icon Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- John Boyages, MB BS(Hons), FRANZCR, PhD, AM, Study chair, Integrated Community Oncology Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909032
- Sponsor's protocol ID
- 23.05
- Acronym
- PUMA
- Status last verified
- Mar 2025
- First submitted
- 27 Mar 2025
- Last updated
- 3 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06909032
- Acronym / sponsor ID
- PUMA / 23.05
- Conditions
- Breast Cancer
- Keywords
- Partial breast irradiation (PBI), Patient reported outcomes, Breast cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Integrated Community Oncology NetworkUniversity, hospital or other
- Collaborators
- Icon Cancer Foundation
- Study start
- Apr 2025 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Hypofractionated PBI delivering a total dose of 30 Gy in five consecutive daily fractions. | Active comparator | Radiation: Accelerated partial breast irradiationPBI 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. |
| Arm B: Hypofractionated PBI delivering a total dose of 26 Gy in five consecutive daily fractions. | Active comparator | Radiation: Accelerated partial breast irradiationThe 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (18 listed)
- Ink on surgical margins or positive histological margins
- Lymphatic vessel invasion (LVI)
- Bilateral breast cancer
- Invasive lobular carcinoma
- Pleomorphic LCIS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated partial breast irradiationAccelerated 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. | Radiation | 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. |
Primary outcome
Patient-reported breast-related cosmetic outcome,
Time frame: 36 months post randomisation
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).
9 secondary outcomes
Patient-reported breast-related cosmetic outcome
Time frame: Baseline, 8 weeks post-treatment, 6, 12, 18, 24 and 36-months post randomisation.
Patient-reported breast-related functional outcome
Time frame: Baseline, 8 weeks post-treatment, 6, 12, 18, 24 and 36-months post randomisation.
Patient-reported quality of life
Time frame: Baseline, 8 weeks post-treatment, 6, 12, 18, 24 and 36-months post randomisation.
Ipsilateral breast tumour recurrence (IBTR)
Time frame: Up to 36 months post-randomisation
Regional Recurrence
Time frame: Up to 36 months post-randomisation
Locoregional disease recurrence
Time frame: Up to 36 months post-randomisation
Distant disease recurrence
Time frame: Upto 36 months post-randomisation
Patterns of care for treatment of disease recurrence (IBTR, locoregional, or metastatic)
Time frame: Upto 36 months post-randomisation
Patient satisfaction with treatment
Time frame: At 8-weeks and 12 months post-treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
John Boyages, MB BS(Hons), FRANZCR, PhD, AM study chair
Integrated Community Oncology Network
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated partial breast irradiation in people with Breast Cancer, run by Integrated Community Oncology Network at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John Boyages, MB BS(Hons), FRANZCR, PhD, AM (+612 9480 4200, John.Boyages@icon.team), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported breast-related cosmetic outcome, (time frame: 36 months post randomisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.