No Sentinel Node Biopsy for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byAlice Chung, MD

Age: 65+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Cedars-Sinai Medical Center

No Placebo Group

Approved in 5 Jurisdictions

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.

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.

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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.

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Treatment Details

Interventions

Lumpectomy (N/A)

Trial OverviewThe 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

1Treatment groups

Experimental Treatment

Group I: Lumpectomy without sentinel node biopsyExperimental Treatment1 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 Canada, Japan for the following indications: