A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
The primary objective of this study is to determine in women with node negative BC ≤3cm in size, if PBI compared to WBI, both given once-a-day over 1 week following BCS, is non-inferior for LR and reduces adverse cosmesis. The primary outcomes are LR and patient-assessed cosmesis at 3 years post randomization.
Study details:
This is a randomized, two-arm, single blinded trial comparing two radiation treatment modalities, PBI and WBI. Following BCS or on the completion of additional adjuvant chemotherapy, eligible and consenting patients with newly diagnosed and histologically confirmed invasive carcinoma of the breast (without evidence of metastatic disease); with microscopically clear resection margins of 1mm (or no residual disease on re-excision) and negative axillary node involvement will be randomized in a 1:1 fashion to receive either PBI (experimental group) or WBI (control group). Study participants will receive 26Gy in 5 fractions in both treatment arms, treated once per day, for a period of 5-7 days.
Study participants will not be made aware of treatment allocation to prevent any potential bias in their assessment of cosmesis. Stratification factors include tumour size, estrogen receptor (ER) status, and clinical centre.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease (see AJCC TNM Cancer Staging, Appendix II).
- Treated by BCS with microscopically clear resection margins >= 1mm for invasive and non-invasive disease or no residual disease on re-excision.
- Negative axillary node involvement as determined by either sentinel lymph node biopsy or axillary node dissection or clinical assessment with a negative axillary ultrasound and/or biopsy, for women with unifocal tumours <= 2cm, histologic grade 1 or 2, ER or PR+ and HER2-ve that are being planned for endocrine therapy
Exclusion criteria
- Age less than 50 years.
- Known to be BRCA 1 and/or BRCA 2 positive.
- Tumour size >3cm in greatest diameter on pathological examination.
- Evidence of extensive intraductal component (EIC) (defined as an invasive tumour with a ductal carcinoma in situ (DCIS) component comprising at least 25% and extending beyond the invasive component to surrounding normal breast tissue) with the following exception: smaller tumours with EIC where the combined size (of the invasive and DCIS components) are <= 3cm remain eligible
- Evidence of a DCIS component > 3cm
- Lobular carcinoma only.
- More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible).
- Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible).
- History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma.
- Known pregnancy or currently lactating.
- Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma).
- Inability to plan the patient for the experimental technique.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: FEMALE
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT05417516
Intervention or treatment
RADIATION: Whole Breast Irradiation (WBI)
RADIATION: Partial Breast Irradiation (PBI)
Conditions
- Breast Neoplasm Female
- Radiotherapy
- Cosmetic Outcome
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Research sites nearby
Closest Location:
GenesisCare Hurstville
Select from list below to view details:
GenesisCare Hurstville
Hurstville, New South Wales, Australia
GenesisCare Mater Hospital
North Sydney, New South Wales, Australia
GenesisCare Bundaberg
Bundaberg, Queensland, Australia
GenesisCare Southport
Southport, Queensland, Australia
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Who is running the clinical trial?
Ontario Clinical Oncology Group (OCOG)
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/Arm | Intervention/Treatment |
|---|---|
ACTIVE_COMPARATOR: Whole Breast Irradiation (WBI)
| Radiation: Whole Breast Irradiation (WBI) |
EXPERIMENTAL: Partial Breast Irradiation (PBI)
| Radiation: Partial Breast Irradiation (PBI) |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Local Recurrence | Time from randomization to any evidence of tumour recurrence (invasive and non-invasive) in the treated breast. | Annually for 5 years post-randomization |
| Patient Assessment Cosmesis at 3 years | Cosmesis will be assessed by the patient using the Breast Cosmesis Questionnaire which incorporates the Modified EORTC Breast Cosmetic Rating System and the UK Patient Reported Outcomes Questions following BCS. | 3 and 5 years post-randomization |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Distant Disease Free Survival (DDSF) | Time from randomization to evidence of metastasis involving distant sites (e.g. bone, liver, lung, or brain). | Annually for 5 years post-randomization. |
| Disease Free Survival (DFS) | Time from randomization to local recurrence, regional or distant recurrence, contralateral breast cancer, other second cancer, or death. | Annually for 5 years post-randomization. |
| Overall Survival | Time from randomization to death of any cause. | 3 years post-randomizaton. |
| Radiation Toxicity | Acute (2 weeks and up to 3 months after completing RT) and late toxicity (beyond the 3 months after completing RT) will be assessed by clinical centre personnel using the NCI CTCAE version 5.0. | 2 weeks and 3 months post-radiation treatment, then annually for 5 years post-randomization. |
| Nurse/Clinical Research Associate assessed cosmesis at 3 and 5 years. | A nurse/Clinical Research Associate (CRA) assessment of cosmesis using the EORTC Breast Cosmetic Rating System. Nurses and CRAs will be training in assessing cosmesis using training slides and guide previously developed for other trials. | 3 and 5 years post-randomization. |
| Patient Assessed Cosmesis at 5 years. | Cosmesis will be assessed by the patient using the Breast Cosmesis Questionnaire which incorporates the Modified EORTC Breast Cosmetic Rating System13,27,42 and the UK Patient Reported Outcomes Questions following BCS. | 5 years post-randomization. |
| Patient Reported Quality of Life | Patients will complete the EORTC Breast Cancer Quality of life questionnaire | 2 weeks post-radiation treatment, then at 3 and 5 years post-randomization. |
References
Clinical Trials Gov: A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)Other trials to consider
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