Comparing Whole Breast Irradiation with Partial Breast Irradiation for breast neoplasm female
Official title: A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
A Randomized Trial of Five-Fraction Partial Breast Irradiation (RAPID2)
Interventions
Whole Breast Irradiation (WBI)
The dose fractionation and prescription is 26Gy in 5 fractions to the PTV once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).
Partial Breast Irradiation (PBI)
The dose fractionation and prescription is 26Gy in 5 fractions to the PTV prescribed at the isocentre of the treatment fields treated once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).
Canadian Sites (18)
Arthur J. E. Child Comprehensive Cancer Centre-Clinical Research Unit
Calgary, Alberta, Canada
BCCA-Vancouver Island Cancer Centre
Victoria, British Columbia, Canada
QEII HSC - Nova Scotia Cancer Centre
Halifax, Nova Scotia, Canada
Royal Victoria Regional Health Centre
Barrie, Ontario, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
London Regional Cancer Centre
London, Ontario, Canada
Stronach (Southlake) Regional Health Centre
Newmarket, Ontario, Canada
Algoma District Cancer Program
Sault Ste. Marie, Ontario, Canada
Princess Margaret Hospital
Toronto, Ontario, Canada
Toronto-Sunnybrook Health Sciences Centre - Odette Cancer Centre
Toronto, Ontario, Canada
Windsor Regional Cancer Centre
Windsor, Ontario, Canada
CSSS Champlain - Charles LeMoyne
Greenfield Park, Quebec, Canada
CHUM - Centre Hospitalier de L'Université de Montréal
Montreal, Quebec, Canada
McGill University Health Centre
Montreal, Quebec, Canada
CHUQ-Pavillon Hotel-Dieu de Quebec
Québec, Quebec, Canada
CHUS-Hopital Fleurimont
Sherbrooke, Quebec, Canada
Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-Centre-du-Québec (CIUSSS MCQ)
Trois-Rivières, Quebec, Canada
Saskatoon Cancer Centre
Saskatoon, Saskatchewan, Canada
Eligibility Criteria
See who this study is looking for17 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +For inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → in this study, patients must fulfill all of the following 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
- −Patients who satisfy any of the following exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are NOT eligible for this study:
- −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.
- −Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma).
- −Inability to plan the patient for the experimental technique.
- −Known pregnancy or currently lactating.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Whole Breast Irradiation (WBI), Partial Breast Irradiation (PBI).
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
There are 2 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 50 years to 120 years.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 910 people.
The study is currently expected to finish around November 2031.
The main measurement is taken over: Annually for 5 years post-randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Local Recurrence — measured over Annually for 5 years post-randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
Patient Assessment Cosmesis at 3 years — measured over 3 and 5 years post-randomization.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT05417516 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Whole Breast Irradiation (WBI)Radiation
The dose fractionation and prescription is 26Gy in 5 fractions to the PTV once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
About Partial Breast Irradiation (PBI)Radiation
The dose fractionation and prescription is 26Gy in 5 fractions to the PTV prescribed at the isocentre of the treatment fields treated once per day over 5-7 days (due to holiday weekends up to 8 days will be acceptable).
From the trial registry — its own words, unedited.
What a radiation is here: A form of radiotherapy or radiation-based treatment being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 50 years to 120 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 50 years to 120 years.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Annually for 5 years post-randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →.
The study as a whole is currently expected to finish around 2031-11.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 910 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 16 locations, including: Calgary, Alberta, Canada; Victoria, British Columbia, Canada; Halifax, Nova Scotia, Canada; Barrie, Ontario, Canada; Hamilton, Ontario, Canada; London, Ontario, Canada, and 10 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.