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Upfront TAD/SNB for Breast Cancer

Phase 2
Recruiting
Led By Alice Chung, MD
Research Sponsored by Alice Chung
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Women age ≥ 45
Clinical T1-2N0 ER+ invasive breast cancer
Must not have
More than 2 suspicious nodes on preoperative imaging
Palpable nodes on physical exam
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

This trial aims to understand how often breast cancer comes back and how long patients live after treatment. They will study patients with a specific type of breast cancer who have lymph node involvement. The patients will undergo

Who is the study for?
This trial is for women aged 45 or older with a specific type of breast cancer (ER+/Her2- invasive) that's early stage (T1-2N0) and has spread to the axillary lymph nodes as confirmed by ultrasound-guided biopsy. Participants must be able to give informed consent and follow study requirements.
What is being tested?
The study is testing if treating patients with upfront lumpectomy or mastectomy followed by Targeted Axillary Dissection (TAD) and Sentinel Node Biopsy (SNB), then adjuvant therapy, affects recurrence rates and survival in this particular breast cancer population.
What are the potential side effects?
Potential side effects may include complications from surgery such as pain, infection, or lymphedema; radiation therapy could cause skin irritation, fatigue, or more rarely long-term tissue damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a woman aged 45 or older.
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My breast cancer is early stage, has not spread to lymph nodes, and is estrogen receptor positive.
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My underarm lymph nodes have cancer, confirmed by a biopsy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My scans show more than 2 suspicious lymph nodes.
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I can feel lumps in my lymph nodes.
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My breast cancer is either HER2 positive or estrogen receptor negative.
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My cancer has spread beyond the lymph node by more than 3 mm.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 rate
Secondary outcome measures
Breast cancer specific survival (BCSS) rate
Disease-free survival (DFS)
Local recurrence rate
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single ArmExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Adjuvant Radiation Therapy
2014
Completed Phase 2
~60

Find a Location

Who is running the clinical trial?

Alice ChungLead Sponsor
Alice Chung, MDPrincipal InvestigatorCedars-Sinai Medical Center
2 Previous Clinical Trials
248 Total Patients Enrolled
~30 spots leftby Apr 2031
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