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RecruitingLast updated: 23 April 2026

PUMA: Evaluating different dose levels of targeted radiation therapy when given after surgery for people with early breast cancerAccelerated 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

Trial purpose

Medical clipboardCancer treatment

Tumor type

Breast Cancers Breast

Age

People50+

Trial acronym

PUMA

Clinical summary

Summary

Who is it for?
You may be eligible for this trial if you are aged over 50 who has been diagnosed with early-stage breast cancer and will be undergoing radiation therapy following surgery for your cancer.

Study details
All participants in this study will receive a type of breast cancer treatment called Accelerated Partial Breast Irradiation (APBI) using a method called Volumic Modulated Arc Therapy (VMAT).

Only the part of the breast where the cancer has been surgically removed will receive radiation therapy (partial bresast irradiation or PBI), rather than the whole breast (whole breast irradiation). This approach can reduce the toxic effects of radiation therapy.

The treatment starts within 12 weeks after breast-convserving surgery and involves a planning session with a CT scan to help plan the treatment, which takes about an hour. After this, participants will take part in five daily 15-minute treatment sessions over one week.

Participants in this study will be randomly allocated (by chance) to receive one of two doses of treatment (26Gy or 30 Gy).

All participants will then be followed up for 3 years to assess quality of life and if there are any recurrences of cancer.

It is hope that this study will help determine if participant quality of life is th same with a higher dose compared to a slightly lower dose. This will help then decide the best dose for future patients with early breast cancer. 

Conditions

This trial is treating people with early-stage breast cancer.

Eligibility

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.

Inclusion

  • Your cancer has not spread to other parts of the body (localised).

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ANZCTR, ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Integrated Community Oncology Network

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

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