Surgery vs Pre-Surgery Radiotherapy for Breast Cancer
(NORDIS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial compares two treatments for a type of breast cancer called DCIS. One group will have surgery, while the other will have radiation followed by surgery. The goal is to see if radiation before surgery improves treatment outcomes.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it does mention that endocrine therapy (hormone treatment) is not allowed from the time of study randomization to the completion of surgery, unless it's for a cancer in the opposite breast.
Is breast-conserving surgery with radiotherapy generally safe for humans?
How does the treatment of lumpectomy with pre-surgery radiotherapy differ from other breast cancer treatments?
Lumpectomy, also known as breast-conserving surgery, is unique because it removes only the cancerous part of the breast, preserving most of the breast tissue, and is often combined with radiotherapy to prevent cancer recurrence. This approach contrasts with mastectomy, which involves removing the entire breast, and offers similar survival rates while maintaining the breast's appearance.678910
What data supports the effectiveness of the treatment involving surgery and pre-surgery radiotherapy for breast cancer?
Research shows that lumpectomy followed by breast irradiation is effective for early-stage breast cancer, with high survival rates and reduced local recurrence. Additionally, preoperative radiotherapy is being explored to enhance treatment effectiveness and allow for more conservative surgeries.1112131415
Who Is on the Research Team?
Irene Wapnir, MD
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for individuals with non-palpable, image-detected ductal carcinoma in situ (DCIS) of the breast measuring up to 4 cm. Participants must have a biopsy marker placed and an ECOG performance status of 0-2. Prior contralateral breast cancer is okay, but not ipsilateral cancer or multicentric/multifocal DCIS, Paget's disease, invasive carcinoma on biopsy, mass lesions/palpable tumors over 4 cm, or positive lymph nodes.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Neoadjuvant Radiotherapy
Participants receive partial breast irradiation once a day for 5 days before surgery
Surgical Excision
Participants undergo surgical excision of ductal carcinoma
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Lumpectomy
- Partial breast irradiation
Lumpectomy is already approved in European Union, United States, Canada, Japan for the following indications:
- Early-stage breast cancer
- Low-risk breast cancer
- Early-stage breast cancer
- Low-risk breast cancer
- Ductal carcinoma in situ (DCIS)
- Early-stage breast cancer
- Low-risk breast cancer
- Early-stage breast cancer
- Low-risk breast cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor