Breast Neoplasm Female study: Whole Breast Irradiation vs Partial Breast Irradiation
Official title A Randomized Trial of Five Fraction Partial Breast Irradiation (RAPID2)
ClinicalTrials.gov ID: NCT05417516
What this study is testing
- What it's testing
- The study wants to find out if partial‑breast irradiation is not worse than whole‑breast irradiation for preventing cancer return and if it leads to better cosmetic results.
- Who it's for
- Women who have had breast‑conserving surgery for a tumor 3 cm or smaller that has not spread to lymph nodes.
- What's involved
- Participants will receive either partial‑breast or whole‑breast radiation once a day for one week and will complete follow‑up visits and cosmetic questionnaires.
- Time commitment
- Treatment lasts one week, with follow‑up visits over a three‑year period.
- Phase 3: a large, late-stage study
- Time commitment: about 1 week
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 to 120, women only
You may be able to join if
- Female with a new histological diagnosis of invasive carcinoma of the breast with no evidence of metastatic disease (see AJCC TNM Cancer Staging...
- 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...
You likely can't join 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...
- Evidence of a DCIS component \> 3cm
- Lobular carcinoma only.
See the full eligibility 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Darlinghurst, New South Wales, Australia
- Hurstville, New South Wales, Australia
- North Sydney, New South Wales, Australia
- Bundaberg, Queensland, Australia
- Southport, Queensland, Australia
- Tugun, Queensland, Australia
- Urraween, Queensland, Australia
- Adelaide, South Australia, Australia
- Bedford Park, South Australia, Australia
- Wembley, Washington, Australia
- Murdoch, Western Austrailia, Australia
- Nedlands, Western Australia, Australia
- Calgary, Alberta, Canada
- Victoria, British Columbia, Canada
- Halifax, Nova Scotia, Canada
- Barrie, Ontario, Canada
- Hamilton, Ontario, Canada
- London, Ontario, Canada
- Newmarket, Ontario, Canada
- Sault Ste. Marie, Ontario, Canada
+ 8 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 1 week per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling female, 50 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Darlinghurst, New South Wales, Australia; Hurstville, New South Wales, Australia; North Sydney, New South Wales, Australia; Bundaberg, Queensland, Australia; Southport, Queensland, Australia; Tugun, Queensland, Australia and 22 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.