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N/A

No Sentinel Node Biopsy for Breast Cancer

N/A
Recruiting
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.
Patients enrolled after surgery: pT1-2NX, or pT1-2N0, ER+, HER2-negative, invasive breast cancer. DCIS or LCIS may be present with invasive cancer.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of diagnosis until the date of death from any cause assessed up to 5 years.
Awards & highlights

Study 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.Check my eligibility
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.See study design
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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My breast cancer was early stage, ER positive, HER2 negative, and possibly had DCIS or LCIS.
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I plan to have or had a lumpectomy recently without a sentinel node biopsy.
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My lymph nodes felt normal and a biopsy confirmed they are cancer-free.
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I am a woman aged 65 or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of diagnosis until the date of locoregional or distant recurrence assessed up to 5 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of diagnosis until the date of locoregional or distant recurrence assessed up to 5 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Regional recurrence
Secondary outcome measures
Disease-free survival
Overall survival

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
497 Previous Clinical Trials
164,359 Total Patients Enrolled
16 Trials studying Breast Cancer
1,924 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this clinical research endeavor still open?

"According to clinicaltrials.gov, the recruitment for this research is still open. The announcement of the trial was made on January 22nd 2016 and it has been updated most recently on July 15th 2022."

Answered by AI

What is the sample size of this trial's participants?

"Affirmative. Clinicaltrials.gov attests that this research endeavor launched on January 22nd 2016 and was amended lastly on July 15th 2022, is actively recruiting 200 participants from a single medical location."

Answered by AI
~4 spots leftby Jun 2024