A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)

NCT05417516 | Recruiting Phase 3 DMC

• 1 other identifier: OCOG-2022-RAPID2
• Study Type: interventional
• Target: 910
• Locations: 2 countries
• Sites: 28

Brief Summary

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.

Conditions

Breast Neoplasm Female; Radiotherapy; Cosmetic Outcome

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Distant Disease Free Survival (DDSF)

  Annually for 5 years post-randomization.

• Disease Free Survival (DFS)

  Annually for 5 years post-randomization.

• Overall Survival

  3 years post-randomizaton.

• Radiation Toxicity

  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.

  3 and 5 years post-randomization.

Study Arms (2)

Whole Breast Irradiation (WBI)

ACTIVE COMPARATOR

26 Gy in 5 fractions to the whole breast

Radiation: Whole Breast Irradiation (WBI)

Partial Breast Irradiation (PBI)

EXPERIMENTAL

26 Gy in 5 fractions to the tumour bed with a margin of normal tissue

Radiation: Partial Breast Irradiation (PBI)

Interventions

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).

Whole Breast Irradiation (WBI)

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).

Partial Breast Irradiation (PBI)

Eligibility Criteria

• Age: 50 Years - 120 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ontario Clinical Oncology Group (OCOG): lead

Study Sites (28)

GenesisCare Darlinghurst

Darlinghurst, New South Wales, 2010, Australia

NOT YET RECRUITING

GenesisCare Hurstville

Hurstville, New South Wales, 2220, Australia

RECRUITING

GenesisCare Mater Hospital

North Sydney, New South Wales, 2060, Australia

RECRUITING

GenesisCare Bundaberg

Bundaberg, Queensland, 4670, Australia

RECRUITING

GenesisCare Southport

Southport, Queensland, 4215, Australia

RECRUITING

GenesisCare Tugun

Tugun, Queensland, 4224, Australia

RECRUITING

GenesisCare Hervey Bay

Urraween, Queensland, 4655, Australia

RECRUITING

GenesisCare St Andrew's

Adelaide, South Australia, 5000, Australia

RECRUITING

GenesisCare Wembley

Wembley, Washington, 6014, Australia

RECRUITING

GenesisCare Fiona Stanley Hospital

Murdoch, Western Austrailia, 6150, Australia

RECRUITING

GenesisCare Hollywood

Nedlands, Western Australia, 6009, Australia

RECRUITING

Arthur J. E. Child Comprehensive Cancer Centre-Clinical Research Unit

Calgary, Alberta, Canada

RECRUITING

BCCA-Vancouver Island Cancer Centre

Victoria, British Columbia, Canada

NOT YET RECRUITING

QEII HSC - Nova Scotia Cancer Centre

Halifax, Nova Scotia, Canada

RECRUITING

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

RECRUITING

Juravinski Cancer Centre

Hamilton, Ontario, Canada

RECRUITING

London Regional Cancer Centre

London, Ontario, Canada

RECRUITING

Stronach (Southlake) Regional Health Centre

Newmarket, Ontario, Canada

RECRUITING

Algoma District Cancer Program

Sault Ste. Marie, Ontario, Canada

RECRUITING

Princess Margaret Hospital

Toronto, Ontario, Canada

RECRUITING

Toronto-Sunnybrook Health Sciences Centre - Odette Cancer Centre

Toronto, Ontario, Canada

RECRUITING

Windsor Regional Cancer Centre

Windsor, Ontario, N8W2X3, Canada

RECRUITING

CSSS Champlain - Charles LeMoyne

Greenfield Park, Quebec, Canada

RECRUITING

CHUM - Centre Hospitalier de L'Université de Montréal

Montreal, Quebec, H2L 4M1, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

RECRUITING

CHUQ-Pavillon Hotel-Dieu de Quebec

Québec, Quebec, Canada

RECRUITING

Centre Intégré Universitaire de Santé et de Services Sociaux de la Mauricie-Centre-du-Québec (CIUSSS MCQ)

Trois-Rivières, Quebec, G8Z 3R9, Canada

RECRUITING

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

RECRUITING

Study Officials

• Timothy Whelan, M.D.

  Juravinski Cancer Centre and McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelley Chambers, MA

CONTACT

905-527-2299; schamber@mcmaster.ca

Erin McGean

CONTACT

905-527-2299; mcgeane@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Study participants will be made unaware of treatment allocation to prevent any potential bias in their assessment of cosmesis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 14, 2022
• Study Start: November 20, 2023
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2031
• Last Updated: April 13, 2026

Record last verified: 2026-03

Locations

CA (17); AU (11)