50 Participants Needed

Surgery vs Pre-Surgery Radiotherapy for Breast Cancer

(NORDIS Trial)

SP
Overseen BySinyoung Park
Stay on Your Current MedsYou can continue your current medications while participating
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 5 JurisdictionsThis treatment is already approved in other countries

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?

Breast-conserving surgery with radiotherapy is considered a safe option for most women with early breast cancer, with studies showing good long-term outcomes and patient satisfaction.12345

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 | Stanford Health Care

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

My breast scan shows a non-mass lesion 4 cm or smaller.
I can take care of myself and perform daily activities.
I may have abnormal cells or lobular carcinoma in either breast.
See 8 more

Exclusion Criteria

Pregnant or breastfeeding
I have no remaining signs of the lesion after my biopsy.
My breast cancer is larger than 4 cm on imaging tests.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Radiotherapy

Participants receive partial breast irradiation once a day for 5 days before surgery

1 week
5 visits (in-person)

Surgical Excision

Participants undergo surgical excision of ductal carcinoma

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Lumpectomy
  • Partial breast irradiation
Trial Overview The study compares immediate surgical removal (lumpectomy) versus radiation therapy followed by delayed surgery for treating DCIS. The goal is to assess which method is more effective based on pathological findings from the excised tissue.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Neoadjuvant partial breast irradiationExperimental Treatment2 Interventions
Partial breast irradiation will be delivered once a day for 5 days before surgery. The planned daily dose is 6 Gy.
Group II: Surgical ExcisionActive Control1 Intervention
Surgical excision of ductal carcinoma

Lumpectomy is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Lumpectomy for:
  • Early-stage breast cancer
  • Low-risk breast cancer
🇺🇸
Approved in United States as Lumpectomy for:
  • Early-stage breast cancer
  • Low-risk breast cancer
  • Ductal carcinoma in situ (DCIS)
🇨🇦
Approved in Canada as Lumpectomy for:
  • Early-stage breast cancer
  • Low-risk breast cancer
🇯🇵
Approved in Japan as Lumpectomy for:
  • Early-stage breast cancer
  • Low-risk breast cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

Published Research Related to This Trial

In a study of 1843 women with Stage I or II breast cancer, lumpectomy followed by breast irradiation resulted in a significantly lower rate of local tumor recurrence (90% remained free of ipsilateral breast tumor) compared to those who did not receive irradiation (61%).
After eight years of follow-up, the overall survival rates and distant-disease-free survival rates were similar between women who underwent lumpectomy (with or without irradiation) and those who had total mastectomy, indicating that lumpectomy is a viable treatment option for early-stage breast cancer.
Eight-year results of a randomized clinical trial comparing total mastectomy and lumpectomy with or without irradiation in the treatment of breast cancer.Fisher, B., Redmond, C., Poisson, R., et al.[2022]
In a study of 190 women with breast cancer, segmental resection was found to be oncologically safe, showing no significant difference in positive resection margins compared to standard lumpectomy, indicating both techniques are effective for breast conservation.
Segmental resection can effectively treat larger tumors (average size 26.6 mm) while maintaining comparable cosmetic satisfaction to standard lumpectomy, which typically treats smaller tumors (average size 17.0 mm).
Comparative study of surgical margins and cosmetic outcome in lumpectomy versus segmental resection in breast cancer.Eggemann, H., Ignatov, A., Krocker, J., et al.[2014]
Accelerated partial breast irradiation (APBI) offers a shorter treatment option compared to traditional whole breast irradiation (WBI), potentially increasing access to breast-conserving therapy for women with early-stage breast cancer.
While APBI techniques show similar local control rates to WBI in selected patients, the follow-up data on their long-term efficacy is limited, necessitating careful patient selection based on evidence-based criteria.
Accelerated partial breast irradiation: potential roles following breast-conserving surgery.Biagioli, MC., Harris, EE.[2017]

Citations

Eight-year results of a randomized clinical trial comparing total mastectomy and lumpectomy with or without irradiation in the treatment of breast cancer. [2022]
Comparative study of surgical margins and cosmetic outcome in lumpectomy versus segmental resection in breast cancer. [2014]
Accelerated partial breast irradiation: potential roles following breast-conserving surgery. [2017]
Preoperative Radio(Chemo)Therapy in Breast Cancer: Time to Switch the Perspective? [2023]
Frontiers in radiotherapy for early-stage invasive breast cancer. [2021]
Reduction mammaplasty and mastopexy in previously irradiated breasts. [2016]
Is Mastectomy Oncologically Safer than Breast-Conserving Treatment in Early Breast Cancer? [2022]
Breast conserving surgery after neoadjuvant therapy for large primary breast cancer. [2021]
Oncological and cosmetic outcomes of oncoplastic breast conserving surgery. [2007]
Breast conservation: long-term results from Westmead Hospital. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Breast-Conserving Therapy is Associated with Improved Survival Without an Increased Risk of Locoregional Recurrence Compared with Mastectomy in Both Clinically Node-Positive and Node-Negative Breast Cancer Patients. [2023]
[Established and new surgical procedures in the therapy of breast cancer]. [2006]
The dilemma of stage III breast cancer: a study of preoperative radiotherapy. [2019]
14.United Statespubmed.ncbi.nlm.nih.gov
Conservation surgery and irradiation for the treatment of favorable breast cancer. [2019]
Benchmarking clinical practice quality: an audit of ipsilateral breast tumor recurrence in patients managed for T1/T2 breast carcinoma. [2018]
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