Surgery for Early-Stage Breast Cancer

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

158 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Wide Excision, Wide Local Excision, WLE for early-stage breast cancer?

Research suggests that wide local excision (WLE) is a popular conservative approach for small breast tumors, and it does not negatively impact body image or quality of life compared to other surgical methods. Additionally, WLE is associated with good cosmetic outcomes, which is important for patients' psychological well-being. ^{1 2 3 4 5}

Is wide local excision (WLE) surgery safe for early-stage breast cancer?

Wide local excision (WLE) surgery is generally considered safe for early-stage breast cancer. Studies have shown that cancers can be safely removed using this method, and it has a low rate of needing additional surgery. Additionally, the choice of surgical approach does not significantly impact patients' body image satisfaction. ^{1 4 5 6 7}

How does the treatment Wide Excision differ from other treatments for early-stage breast cancer?

Wide Excision (WLE) is a breast-conserving surgery that removes the cancerous tissue with a margin of healthy tissue around it, aiming to preserve as much of the breast as possible. Unlike mastectomy, which removes the entire breast, WLE focuses on maintaining breast appearance, although the optimal margin size for excision is still debated among surgeons. ^{1 2 4 7 8}

What is the purpose of this trial?

The purpose of this study is to determine if wide excision (surgical removal) alone is adequate treatment for small, grade 1 or 2 ductal carcinoma in situ (DCIS) of the breast.

Research Team

Julia Wong, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Size does matter: High volume breast surgeons accept smaller excision margins for wide local excision--a national survey of the surgical management of wide local excision margins in UK breast cancer patients. [2016]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Mastectomy rates remain high in Singapore and are not associated with poorer survival after adjusting for age. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Frequency of residual melanoma in wide local excision (WLE) specimens after complete excisional biopsy. [2015]

4. Australia pubmed.ncbi.nlm.nih.gov

Achieving margin clearance following oncoplastic breast surgery in comparison with simple wide local excision: a three-dimensional specimen assessment. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Body image score following anterior and lateral approaches to wide local excision for early breast cancer. [2007]

6. India pubmed.ncbi.nlm.nih.gov

An Audit on Oncological Safety with Magseed Localised Breast Conserving Surgery. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Comparative efficacy of different reconstruction methods after wide local excision of the nail unit: A retrospective study. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Variation in the practice of wide local excision for melanoma in Ireland and the United Kingdom: a questionnaire survey. [2023]