Breast-Conserving Surgery for Ductal Carcinoma In Situ

(ELISA Trial)

Recruiting at 27 trial locations

Overseen By Daryl Hannah Soloman

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ontario Clinical Oncology Group (OCOG)

Disqualifiers: Multifocal DCIS, Invasive cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Surgery and analysis period

526 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether women with low-risk ductal carcinoma in situ (DCIS), a type of non-invasive breast cancer, can safely skip radiation therapy after breast-conserving surgery, which removes cancer while preserving as much normal breast tissue as possible. Researchers aim to determine if certain medical factors and the Oncotype DX DCIS score can identify candidates who can avoid radiation. Suitable participants are women over 45 who have undergone breast-conserving surgery with a small tumor (2.5 cm or less) and clear surgical margins. The goal is to determine if some women can safely avoid radiation and its side effects. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant findings.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that breast-conserving surgery is likely to be safe for humans?

Research has shown that breast-conserving surgery (BCS), or lumpectomy, safely treats breast cancer. Studies have found that BCS can lead to better survival rates than mastectomy, which involves removing the entire breast. This surgery not only ensures safety but also preserves the breast's appearance, which many people value.

Many studies indicate that BCS does not increase the risk of cancer recurrence compared to mastectomy. Additionally, following BCS with radiation does not reduce long-term survival chances. Simply put, the surgery is both well-tolerated and effective.

Overall, BCS is considered a reliable and safe option for those with low-risk ductal carcinoma in situ (DCIS), a type of early breast cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Breast-conserving surgery alone is unique because it offers a less invasive option for treating low-risk ductal carcinoma in situ (DCIS) compared to the standard approach, which typically includes surgery followed by radiation therapy. This treatment focuses solely on removing the cancerous tissue while preserving as much of the breast as possible, potentially minimizing side effects and improving quality of life. Researchers are excited about this approach because it could simplify treatment without compromising effectiveness for patients with low-risk DCIS, reducing the need for additional therapies.

What evidence suggests that breast-conserving surgery might be an effective treatment for low risk DCIS?

Studies have shown that breast-conserving surgery (BCS) provides overall survival rates comparable to mastectomy for patients with early-stage breast cancer. Research indicates that while survival rates are similar for both procedures, BCS often results in a better quality of life and less noticeable body changes. Additionally, a review of multiple studies found that BCS significantly reduces the risk of cancer recurrence. This makes BCS a strong option for treating low-risk ductal carcinoma in situ (DCIS), especially when doctors use the Oncotype DX DCIS score to guide treatment decisions. Overall, BCS offers a promising approach to effectively managing certain types of breast cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Tim Whelan, M.D

Principal Investigator

Juravinski Cancer Centre

Eileen Rakovitch, M.D.

Principal Investigator

Sunnybrook Research Institute, Sunnybrook Health Science

Are You a Good Fit for This Trial?

Inclusion Criteria

Tumour size ≤ 2.5cm.

Female patient > 45 years of age with DCIS without microinvasion.

Treated by BCS with clear resection margins ≥ 2 mm or no residual disease on re-excision.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Enrollment and Registration

Eligible patients provide informed consent and are registered through the OCOG web-based system

1-2 weeks

Treatment

Participants undergo breast-conserving surgery and have their tumour specimen analyzed for DCIS score

Surgery and analysis period

Follow-up

Participants are monitored annually with bilateral mammograms and breast exams for up to 10 years

10 years

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Breast-Conserving Surgery

Who Is Running the Clinical Trial?

Ontario Clinical Oncology Group (OCOG)

Lead Sponsor

Trials

65

Recruited

42,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8393026/

Improved Survival after Breast-Conserving Therapy ... In our study, BCT was shown to have improved disease-specific outcomes compared to mastectomy alone, emphasizing the important role of adjuvant treatments, ...

2. nature.com nature.com/articles/s41598-025-93491-7

Oncological outcomes of breast-conserving surgery versus ... Similar overall survival (OS) rates have been found with BCS and mastectomy, whereas better quality of life and less mutilation have been shown ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa020989

Twenty-Year Follow-up of a Randomized Study Comparing ... After a median follow-up of 20 years, the rate of death from all causes was 41.7 percent in the group that underwent breast-conserving surgery and 41.2 percent ...

4. academic.oup.com academic.oup.com/intqhc/article/36/2/mzae043/7675300

A meta-analysis of randomized controlled trials comparing ... Our meta-analysis of 34 169 patients from 11 studies showed that BCS significantly reduced the overall recurrence rate at a median follow-up of 29 months.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10524818/

Comparative Effectiveness Analysis of Lumpectomy and ... In data analysis, our main finding is that lumpectomy and mastectomy have comparable long-term overall survival for early-stage elderly female breast cancer ...

6. nature.com nature.com/articles/s41598-025-16215-x

Survival comparison of breast conserving therapy and ... Cohort studies have suggested that breast-conserving therapy (BCT) offers better survival outcomes compared to mastectomy in patients with ...

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2833981

Long-Term Oncologic Outcome of Breast-Conserving ... Many previous studies have demonstrated that BCT is not inferior to mastectomy and yields superior cosmetic outcomes.

8. cancer.org cancer.org/cancer/types/breast-cancer/treatment/surgery-for-breast-cancer/breast-conserving-surgery-lumpectomy.html

Breast-conserving Surgery (Lumpectomy) Choosing BCS plus radiation over mastectomy does not affect a woman's chances of long-term survival. If you think you want breast reconstruction ...

9. academic-med-surg.scholasticahq.com academic-med-surg.scholasticahq.com/article/141854-total-lumpectomy-vs-nipple-sparing-lumpectomy-long-term-outcomes-and-quality-of-life-considerations-in-breast-cancer-surgery-a-narrative-review

Total Lumpectomy vs Nipple-Sparing Lumpectomy Available data show that NSL provides oncologic safety comparable to traditional lumpectomy, with no significant differences in survival or ...