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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

NANOT_YET_RECRUITING

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.

Study details:

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.

Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

  1. Aged greater than or equal to 50 years old
  2. Histologically confirmed Infiltrating ductal carcinoma (IDC) or pure DCIS, less than or equal to 20mm maximum size.
  3. Lobular carcinoma in situ (LCIS) is permitted.
  4. Histologic grade I or II
  5. Estrogen receptor (ER) +/- progesterone receptor (PR) positive in greater than or equal to 10% of cells and HER2 receptor-negative.
  6. Tumour bed identifiable on imaging via surgical clips
  7. Clear surgical margins
  8. Sentinel nodes negative (at least one node taken if invasive and no isolated tumour cells)
  9. No evidence of distant metastasis

Exclusion criteria

  1. Ink on surgical margins or positive histological margins
  2. Lymphatic vessel invasion (LVI)
  3. Bilateral breast cancer
  4. Invasive lobular carcinoma
  5. Pleomorphic LCIS
  6. Multifocal or multicentric invasive cancer
  7. Invasive carcinoma with associated DCIS greater than or equal to 30mm.
  8. Patients receiving neoadjuvant chemotherapy, anti-HER2 agents or endocrine therapy
  9. Patients receiving adjuvant chemotherapy or anti-HER2 agents.
  10. Previous Hodgkin's lymphoma requiring mantle radiation
  11. Prior radiation therapy to the ipsilateral breast
  12. Triple-negative breast cancer
  13. Documented mutation of BRCA1, BRCA2 or TP53, or at high genetic risk of breast cancer
  14. Known inflammatory conditions associated with higher complications after RT, such as active scleroderma, systemic lupus erythematosus (requiring steroids or immune suppressive therapy)
  15. Oncoplastic surgery where the primary tumour site is difficult to delineate
  16. No previous cancer (except BCC or SCC of the skin) unless in remission beyond five years of diagnosis
  17. People who are pregnant or planning to become pregnant
  18. People who are unable or unwilling to comply with protocol requirements.

Eligibility

Age eligible for study : NA

Healthy volunteers accepted : No

Gender eligible for study: ALL

Things to know

Study dates

Study start:

Primary completion:

Study completion finish:

study type

Study type

TREATMENT

phase

Phase

    NA

trial

Study ID

NCT06909032

Intervention or treatment

RADIATION: Accelerated partial breast irradiation

Conditions

  • Breast Cancer

  • Condition: Breast Cancer

  • RADIATION: Accelerated partial breast irradiation

  • Wahroonga, New South Wales, Australia and more

  • Sponsor: Integrated Community Oncology Network

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Are you running this trial?

If you're a clinic or sponsor, you can claim this study

Research sites nearby

Closest Location:

Icon Cancer Centre Wahroonga

Select from list below to view details:

  • Icon Cancer Centre Wahroonga

    Wahroonga, New South Wales, Australia

  • Icon Cancer Centre Windsor Gardens

    Windsor Gardens, South Australia, Australia

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Who is running the clinical trial?

ICON

Integrated Community Oncology Network

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/ArmIntervention/Treatment
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.
Radiation: Accelerated partial breast irradiation
    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.
    Radiation: Accelerated partial breast irradiation

      What is the study measuring?

      Primary Outcome

      MeasureDescriptionTime Frame
      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 Outcome

      MeasureDescriptionTime Frame
      Patient-reported breast-related cosmetic outcomeBCTOS-12 aesthetic sub-scale scoresBaseline, 8 weeks post-treatment, 6, 12, 18, 24 and 36-months post randomisation.
      Patient-reported breast-related functional outcomeBCTOS-12 functional sub-scale scoresBaseline, 8 weeks post-treatment, 6, 12, 18, 24 and 36-months post randomisation.
      Patient-reported quality of lifeBREAST-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 workBaseline, 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).Up to 36 months post-randomisation
      Regional RecurrenceCumulative 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).Up to 36 months post-randomisation
      Locoregional disease recurrenceCumulative incidence of IBTR plus any recurrence in the ipsilateral axillary, supraclavicular or internal mammary chainUp to 36 months post-randomisation
      Distant disease recurrenceCumulative incidence of metastases to distant organs or bone sites measured using results from standard of care imaging (mammogram, ultrasound, MRI).Upto 36 months post-randomisation
      Patterns of care for treatment of disease recurrence (IBTR, locoregional, or metastatic)Documented in patients' medical recordsUpto 36 months post-randomisation
      Patient satisfaction with treatmentAssessed 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."At 8-weeks and 12 months post-treatment.
      Are you running this trial?If you're a clinic or sponsor, you can claim this study.
      Claim this trial

      References

      Clinical Trials Gov: 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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