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N/A

No Sentinel Node Biopsy for Breast Cancer

N/A
Waitlist Available
Led By Alice Chung, MD
Research Sponsored by Cedars-Sinai Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients enrolled prior to surgery: Diagnosis of clinical T1-2N0, ER+, HER2-negative, invasive breast cancer as determined by treating physician. DCIS or LCIS may be present with invasive cancer.
Female age 65 and older
Must not have
Patients planning to have mastectomy or had a mastectomy of the ipsilateral breast
Prior history of ipsilateral (invasive or DCIS) breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up a regional recurrence during six years of follow-up after lumpectomy.
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether it is safe to forgo sentinel node biopsy (SNB) in older women with small, early-stage breast cancer.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on omitting sentinel node biopsy during lumpectomy, potential side effects may include fewer surgical complications and less postoperative pain compared to traditional procedures that include lymph node removal.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have early-stage, ER+ & HER2- invasive breast cancer, diagnosed before surgery.
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I am a woman aged 65 or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am planning to have or have had a mastectomy on one side.
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I have had breast cancer or DCIS in the same breast before.
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I have been diagnosed with a non-invasive breast cancer.
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I have been diagnosed with inflammatory breast cancer.
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My breast cancer is in stage T3 or T4.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~a regional recurrence during six years of follow-up after lumpectomy.
This trial's timeline: 3 weeks for screening, Varies for treatment, and a regional recurrence during six years of follow-up after lumpectomy. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Regional recurrence

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Cedars-Sinai Medical CenterLead Sponsor
509 Previous Clinical Trials
162,558 Total Patients Enrolled
16 Trials studying Breast Cancer
1,888 Patients Enrolled for Breast Cancer
Alice Chung, MDPrincipal Investigator - Cedars-Sinal Medical Center
Cedars-Sinai Medical Center, Providence Saint John's Health Center
2 Previous Clinical Trials
93 Total Patients Enrolled
1 Trials studying Breast Cancer
45 Patients Enrolled for Breast Cancer

Media Library

Lumpectomy (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT02564848 — N/A
Breast Cancer Clinical Trial 2023: Lumpectomy Highlights & Side Effects. Trial Name: NCT02564848 — N/A
~66 spots leftby Mar 2029
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