No Sentinel Node Biopsy for Breast Cancer

Overseen By Amy Oppenheim

Age: 65+

Sex: Female

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Disqualifiers: Inflammatory breast cancer, Neoadjuvant chemotherapy, Mastectomy, Prior ipsilateral cancer, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

200 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will examine the outcomes of lumpectomy, surgery to remove a tumor, without sentinel node biopsy (SNB) for women at least 65 years of age with clinically node-negative breast cancer. Clinically node-negative means that during a physical exam your doctor cannot feel or see that any lymph nodes near the breast area are swollen and there is also no imaging evidence, such as from a mammogram, of nodal involvement.

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

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Lumpectomy, Breast-conserving surgery, Partial mastectomy, Segmental mastectomy for breast cancer?

Research shows that breast-conserving surgery, like lumpectomy and partial mastectomy, is effective for early-stage breast cancer and can have psychological benefits compared to more extensive surgeries. Studies indicate that when combined with radiotherapy, these treatments reduce the chance of cancer returning without increasing the risk of heart-related deaths. ^{1 2 3 4 5}

Is it safe to skip sentinel node biopsy in breast cancer surgery?

Research suggests that skipping sentinel lymph node biopsy (SLNB) in older women with early-stage breast cancer undergoing lumpectomy is considered safe, with low rates of cancer returning in nearby areas. However, the safety of omitting SLNB in women undergoing mastectomy is still uncertain and may depend on the extent of the breast disease and use of radiation therapy. ^{6 7 8 9 10}

How does the treatment Lumpectomy differ from other treatments for breast cancer?

Lumpectomy, also known as breast-conserving surgery, is unique because it involves removing only the cancerous part of the breast rather than the entire breast, allowing for preservation of breast appearance. This approach is often combined with sentinel lymph node biopsy, which is a less invasive method to check if cancer has spread to the lymph nodes, avoiding more extensive surgery if the nodes are cancer-free. ^{1 11 12 13 14}

Research Team

Alice Chung, MD

Principal Investigator

Cedars-Sinal Medical Center

Eligibility Criteria

This trial is for women aged 65 or older with estrogen-positive, HER2-negative breast cancer that hasn't spread to lymph nodes. They should be planning a lumpectomy or have had one recently without sentinel node biopsy. Women with advanced cancer stages, those who've had mastectomy, inflammatory breast cancer, or prior treatments like chemotherapy for the current cancer are not eligible.

Inclusion Criteria

I have early-stage, ER+ & HER2- invasive breast cancer, diagnosed before surgery.

My breast cancer was early stage, ER positive, HER2 negative, and possibly had DCIS or LCIS.

I plan to have or had a lumpectomy recently without a sentinel node biopsy.

Exclusion Criteria

I have had chemotherapy before surgery for my current breast cancer.

I am planning to have or have had a mastectomy on one side.

I have had breast cancer or DCIS in the same breast before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo standard of care lumpectomy without sentinel node biopsy

1 day

Radiation and Hormonal Therapy

Participants receive standard of care radiation on the affected breast and hormonal therapy

6-8 weeks

Follow-up

Participants are monitored for regional recurrence with physical exams every six months for the first two years and then yearly for the last three years

6 years

Physical exams every 6 months for 2 years, then yearly for 3 years

Treatment Details

Interventions

• Lumpectomy

Trial Overview The study is testing the safety and effectiveness of performing a lumpectomy (surgery to remove a breast tumor) without checking the nearby lymph nodes (sentinel node biopsy) in older women with certain types of early-stage breast cancer.

Participant Groups

Group I: Lumpectomy without sentinel node biopsy Experimental Treatment 1 Intervention

Subjects will undergo standard of care lumpectomy. A biopsy of the sentinel node will not be performed. After surgery, subjects will receive standard of care radiation on the affected breast and hormonal therapy.

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

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Findings from Research

Partial mastectomy, which includes procedures like lumpectomy and wide excision, is effective for tumors smaller than 4 cm, and ensuring clear resection margins can significantly reduce the risk of local recurrence.

This surgical approach offers psychological benefits for patients, but it requires careful execution to prevent unacceptable changes in breast shape, and axillary dissection should be performed through a separate incision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Techniques of breast-conserving therapy in breast carcinoma]. Mosny, D.[2008]

References

1. England pubmed.ncbi.nlm.nih.gov

Current surgical management of breast cancer. [2022]

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

[Techniques of breast-conserving therapy in breast carcinoma]. [2008]

3. Canada pubmed.ncbi.nlm.nih.gov

Surgical management of early stage invasive breast cancer: a practice guideline. [2022]

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

Sentinel lymph node biopsy versus axillary lymphadenectomy in patients treated with lumpectomy: an analysis of short-term outcomes. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Evolution in practice patterns of axillary management following mastectomy in patients with 1-2 positive sentinel nodes. [2019]

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

Can We Successfully De-Escalate Axillary Surgery in Women Aged ≥ 70 Years with Ductal Carcinoma in Situ or Early-Stage Breast Cancer Undergoing Mastectomy? [2023]

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

Associations Between Sentinel Lymph Node Biopsy and Complications for Patients with Ductal Carcinoma In Situ. [2021]

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

Characteristics and outcomes of sentinel node-positive breast cancer patients after total mastectomy without axillary-specific treatment. [2014]

9. England pubmed.ncbi.nlm.nih.gov

Sentinel-lymph-node biopsy (SLNB) for melanoma is not complication-free. [2007]

10. England pubmed.ncbi.nlm.nih.gov

Clinically node negative breast cancer patients undergoing breast conserving therapy, sentinel lymph node procedure versus follow-up: a Dutch randomized controlled multicentre trial (BOOG 2013-08). [2018]

11. Italy pubmed.ncbi.nlm.nih.gov

[The sentinel lymph node biopsy. Evolution and convalidation of the technique]. [2008]

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

Breast cancer: advances in surgical management. [2019]

13. Japan pubmed.ncbi.nlm.nih.gov

[Study of the Identification Rate of Sentinel Lymph Node Biopsy after Partial Breast Resection]. [2016]

14. Japan pubmed.ncbi.nlm.nih.gov

[Sentinel node biopsy in breast cancer]. [2014]