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

Launched by ONTARIO CLINICAL ONCOLOGY GROUP (OCOG) · Jun 9, 2022

Keywords

ClinConnect Summary

The RAPID2 trial is studying a treatment option for women with early-stage breast cancer. Specifically, it is comparing two types of radiation therapy: Partial Breast Irradiation (PBI), which targets only the area around the tumor, and Whole Breast Irradiation (WBI), which treats the entire breast. Both treatments are given once a day for one week after surgery to remove the tumor. The goal is to see if PBI is just as effective at preventing cancer from coming back and whether it results in better cosmetic outcomes, meaning how the breast looks after treatment, compared to WBI.

To participate in this trial, women must be 50 years or older and have early-stage breast cancer that is no larger than 3 centimeters and does not have cancer in the lymph nodes. They should have had surgery to remove the tumor with clear margins, meaning no cancer cells are seen at the edges of the removed tissue. Participants can expect to receive either type of radiation therapy for one week and will be followed for three years to assess the effectiveness and cosmetic results of their treatment. It's a valuable opportunity for eligible women to contribute to research that could help improve breast cancer treatments in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• For inclusion in this study, patients must fulfill all of the following criteria:
• • 1. 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).
• • 2. Treated by BCS with microscopically clear resection margins \>= 1mm for invasive and non-invasive disease or no residual disease on re-excision.
• • 3. 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:
• Patients who satisfy any of the following exclusion criteria are NOT eligible for this study:
• • 1. Age less than 50 years.
• • 2. Known to be BRCA 1 and/or BRCA 2 positive.
• • 3. Tumour size \>3cm in greatest diameter on pathological examination.
• • 4. 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
• • 5. Evidence of a DCIS component \> 3cm
• • 6. Lobular carcinoma only.
• • 7. More than one primary tumour in different quadrants of the same breast (patients with multifocal breast cancer are eligible).
• • 8. Synchronous or previous contralateral breast cancer (patients with contralateral DCIS or LCIS are eligible).
• • 9. History of non-breast malignancy within the last 5 years other than treated non-melanoma skin cancer or treated in-situ carcinoma.
• • 10. Known pregnancy or currently lactating.
• • 11. Inability to localize tumour bed on CT planning (no evidence of surgical clips or seroma).
• • 12. Inability to plan the patient for the experimental technique.