Surgery for Early-Stage Breast Cancer

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Chemotherapy, Tamoxifen

Disqualifiers: Invasive carcinoma, Nipple discharge, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 7

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether surgery alone can effectively treat a type of early-stage breast cancer called ductal carcinoma in situ (DCIS). Researchers aim to determine if removing the cancerous area through a procedure known as Wide Excision (also called Wide Local Excision or WLE) without follow-up radiation therapy suffices for small, lower-grade cases. Women diagnosed with small, grade 1 or 2 DCIS, and who have had a mammogram showing the affected area, might be suitable candidates for this study. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 exclude patients who are on adjuvant chemotherapy or Tamoxifen.

Is there any evidence suggesting that wide excision is likely to be safe for humans?

Research has shown that wide excision, a surgery to remove cancer from the breast, is generally safe for patients with early-stage breast cancer. Studies have found that patients usually handle this surgery well. The procedure involves removing the cancer along with a small amount of nearby healthy tissue to ensure no cancer cells remain.

One study examined the safety and outcomes of wide excision for breast cancer patients and found that patients often recover well from the surgery. While complications can occur, as with any surgery, they are usually manageable.

This treatment has also been used for other types of breast cancer, suggesting it might be safe for ductal carcinoma in situ (DCIS) as well. Prospective trial participants should discuss any concerns or questions with the research team, who can provide more detailed information about what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for breast cancer?

Researchers are excited about this approach to treating early-stage breast cancer because it explores the potential of omitting radiotherapy (RT) after a wide excision of ductal carcinoma in situ (DCIS). Typically, treatment for DCIS includes surgery followed by RT to reduce recurrence risk. However, by focusing solely on wide excision, this method could decrease the treatment burden and side effects associated with radiotherapy. This could lead to a more streamlined, less invasive treatment option for patients, while still effectively managing the disease.

What evidence suggests that wide excision alone is effective for early-stage breast cancer?

Research has shown that surgically removing the tumor, known as wide excision, can lower the risk of breast cancer returning by 50-60% in patients with ductal carcinoma in situ (DCIS). The success rate of this treatment varies depending on the medical center. Some studies suggest that adding treatments like radiotherapy (RT) can further reduce the chance of cancer recurrence after surgery. However, this trial investigates the effectiveness of surgery alone, specifically wide excision without radiotherapy, for small, low-grade DCIS. The treatment's success depends on removing all cancerous tissue during the surgery. ^{4 6 7 8 9}

Who Is on the Research Team?

Julia Wong, MD

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for individuals with small, low-grade ductal carcinoma in situ (DCIS) of the breast, measuring less than or equal to 2.5 cm. Participants must have had a recent high-quality mammogram and undergone surgical removal with clear margins of at least 1 cm. They should not have invasive cancer, previous breast cancers, nipple discharge, or be on certain cancer treatments like chemotherapy.

Inclusion Criteria

My breast cancer is at an early stage (Grade 1 or 2) and may also have LCIS.

My DCIS is 2.5 cm or smaller.

I have had or will have surgery to remove a breast cancer area with clear margins.

Exclusion Criteria

I have had cancer before, but it was not skin cancer or early-stage cervical cancer.

My cancer has spread to the lymph nodes in my armpit.

I have received chemotherapy or Tamoxifen as a follow-up treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo wide excision surgery for DCIS without radiotherapy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment through physical examinations and mammography

5 years

Physical examinations every 6 months, mammograms every 6 months for 5 years, then annually

What Are the Treatments Tested in This Trial?

Interventions

• Wide Excision

Trial Overview The study is testing if just surgically removing the affected tissue—wide excision—is enough treatment for grade 1 or 2 DCIS without additional therapies. The effectiveness will be observed over time after surgery to ensure all suspicious areas are removed.

How Is the Trial Designed?

Group I: Observation (omission of RT) Experimental Treatment 1 Intervention

Wide excision of DCIS; no radiotherapy (RT).

Wide Excision is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as Wide Local Excision for:

• Invasive cutaneous melanoma

Approved in United States as Wide Local Excision for:

• Invasive cutaneous melanoma

Approved in Canada as Wide Local Excision for:

• Invasive cutaneous melanoma

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Brigham and Women's Hospital

Collaborator

Trials

1,694

Recruited

14,790,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

A study involving 128 clinicians revealed significant variation in the technique of wide local excision (WLE) for melanoma, with most learning their methods informally from colleagues rather than standardized guidelines.

The differences in practice, such as how margins are marked and whether 'dog ears' are sent for histology, suggest that inconsistent WLE techniques could potentially affect patient outcomes, highlighting the need for a consensus statement to standardize practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variation in the practice of wide local excision for melanoma in Ireland and the United Kingdom: a questionnaire survey. O'Connor, E., O'Connor, C., O'Connell, G., et al.[2023]

In a study of 807 wide local excisions (WLE) of melanomas initially diagnosed with complete excisional biopsy, residual melanoma was found in 34 cases (4.2%), indicating that residual disease can occur even after what is thought to be complete removal.

The lentigo maligna subtype of melanoma was identified as having a higher risk of residual disease in WLE specimens, suggesting that while WLE is effective for controlling primary tumors, it may not fully prevent local metastatic recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency of residual melanoma in wide local excision (WLE) specimens after complete excisional biopsy. Bolshinsky, V., Lin, MJ., Serpell, J., et al.[2015]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/jco.2004.22.90140.785

A retrospective review of wide excision alone for ductal ... The major benefit is a 50–60% reduction in the risks of recurrence.The recurrence rates vary from centre to centre .Historically, some centres have had low ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11076345/

Cost-Effectiveness of Radar Localisation Versus Wire ... This is the first published study to date that assessed both surgical outcomes and costs between RL and WL in WLE for early-stage breast cancer.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1526820924002052

Re-Evaluating the Omission of Radiation Therapy in Low ... In intention to treat analysis authors reported after wide local excision, local recurrence was reduced in the radiotherapy arm (HR of 0.37, P < .001). For the ...

4. bmj.com bmj.com/content/378/bmj-2022-070346

Margin status and survival outcomes after breast cancer ... Positive or close margins were associated with increased distant recurrence, local recurrence, and lower overall survival compared with negative ...

5. asj.amegroups.org asj.amegroups.org/article/view/55219/html

Ductal carcinoma in situ: a comprehensive review on current ... RT reduced the absolute 10-year risk of any ipsilateral breast event (recurrent DCIS or invasive cancer) by 15.2% that was effective regardless of age at ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC1964555/

A Review of Current Practices in Breast Conservation ... The aim of this study was to assess whether surgeons in the UK were practising wide excision consistent with current guidelines and current evidence.

7. ascopubs.org ascopubs.org/doi/10.1200/jco.2014.32.26_suppl.91

Ideal breast volume resection during wide local excision Of the 50 patients 44/50 (88%) had a palpable tumour. 52% had T2 tumours, 68% had associated DCIS and 32% were node positive. Mean specimen ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2468294224000054

Surgical margin and local recurrence of ductal carcinoma ... This study aims to evaluate the association between surgical margin status and local recurrence of DCIS.

9. journals.lww.com journals.lww.com/international-journal-of-surgery/fulltext/2010/08070/wide_local_excision_and_sentinel_node_biopsy_for.226.aspx

Wide Local Excision and Sentinel Node Biopsy for Breast... To assess the feasibility of performing wide local excision (WLE) of small invasive breast cancers combined with dual technique sentinel lymph node biopsy (SLNB) ...