What side effects are associated with this type of intervention?

Common treatments for Ductal Carcinoma, such as neoadjuvant radiotherapy, tamoxifen, and aromatase inhibitors, have various side effects. Neoadjuvant radiotherapy can cause acute skin irritation, fatigue, and gastrointestinal issues, with long-term risks including changes in breast texture and lymphedema. Tamoxifen may lead to hot flashes, increased risk of venous thromboembolism, and endometrial cancer. Aromatase inhibitors are associated with bone density loss, fractures, and cardiovascular risks.

What prior FDA approvals exist?

The FDA has approved several treatments for Ductal Carcinoma, including surgical excision, chemotherapy, and radiotherapy. Neoadjuvant radiotherapy, which involves high-energy radiation to shrink tumors before surgery, is a common approach. While specific FDA approvals for neoadjuvant radiotherapy in Ductal Carcinoma are not detailed in the provided context, this method is widely used in clinical practice to improve surgical outcomes. Drugs like anthracyclines and taxanes are often used in combination with radiotherapy to enhance treatment efficacy.

What other types of research exist?

Promising novel alternatives to neoadjuvant radiotherapy for ductal carcinoma patients include targeted therapies (e.g., HER2 inhibitors for HER2-positive cancers), immunotherapies (e.g., checkpoint inhibitors), and advancements in chemotherapy regimens. These approaches can be used alone or in combination with surgery to enhance treatment efficacy and minimize side effects.

← Back to Search

Surgery vs Pre-Surgery Radiotherapy for Breast Cancer (NORDIS Trial)

N/A

Recruiting

Led By Irene Wapnir, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Mammographic or MRI non-mass lesion (calcifications, non-mass enhancement on MRI) measuring 4 cm or less in greatest dimension

ECOG performance status 0, 1, or 2

Must not have

No residual radiographic lesion after diagnostic percutaneous core needle biopsy

Radiographic extent of DCIS >4.0 cm

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects include skin changes like redness and irritation from radiation therapy; pain, swelling, infection risk at the surgery site; fatigue from both treatments; and possible scarring or changes in breast shape.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My breast scan shows a non-mass lesion 4 cm or smaller.

Select...

I can take care of myself and perform daily activities.

Select...

I had cancer in the opposite breast before.

Select...

My breast cancer was found by imaging, not by feeling it, and confirmed with a needle biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have no remaining signs of the lesion after my biopsy.

Select...

My breast cancer is larger than 4 cm on imaging tests.

Select...

I have had breast cancer before in the same breast.

Select...

My breast cancer is in more than one location.

Select...

I have Paget's disease of the breast.

Select...

I have an active connective tissue disease.

Select...

I have cancer in both breasts at the same time.

Select...

My cancer has spread to the lymph nodes under my arm.

Select...

I was not eligible for partial breast irradiation initially.

Select...

I have a lump in my breast that can be felt or seen on scans.

Select...

I have had radiation therapy on the same side of my chest or breast before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Rate of ductal carcinoma in situ (DCIS) pathologic complete response

Secondary study objectives

Correlation of ductal carcinoma in situ (DCIS) subtypes with rate of DCIS pathologic complete response to neoadjuvant partial breast irradiation (PBI)

Correlation of post-radiation imaging characteristics with pathologic findings

Nuclear atypia comparison of radiation-induced treatment effect pathologically pre- versus post-therapy

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lumpectomy

2017

Completed Phase 2

~740

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Neoadjuvant radiotherapy for Ductal Carcinoma involves the use of high-energy radiation to kill cancer cells or shrink tumors before surgery. This approach aims to reduce the tumor size, making surgical removal easier and potentially sparing more healthy tissue. By targeting the tumor preoperatively, it may also reduce the risk of local recurrence, improving surgical outcomes and potentially enhancing long-term survival rates for patients.

Whole-breast irradiation with or without a boost for patients treated with breast-conserving surgery for early breast cancer: 20-year follow-up of a randomised phase 3 trial.