ClinicalTrials.gg
RecruitingNCT06092892Updated Aug 10, 2026

IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases

A Phase 2 interventional study of Breast Surgery (BCS or mastectomy) with TAD/SNB and Adjuvant Radiation Therapy in Breast Cancer, Axillary Nodal Disease and Female Breast Cancer, sponsored by Alice Chung. Recruiting at 3 sites in United States. Open to female participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Alice Chung · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2024; still recruiting 2 years 7 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
45 Years and older
Sex
Female
01

Study summary

The purpose of the study is to determine the recurrence rates and survival of patients with clinical T1-2N0 ER+/Her2- invasive breast cancer who have biopsy proven image detected nodal disease treated with upfront lumpectomy or mastectomy with TAD followed by adjuvant therapy. This is a prospective, single arm phase II clinical trial. Patients will be screened and enrolled per eligibility criteria. Patient, tumor, and treatment data will be documented.

02

Conditions studied

  • Breast Cancer
  • Axillary Nodal Disease
  • Female Breast Cancer
  • Axilla; Breast
  • Mastectomy; Lymphedema
  • Tumor, Breast

Keywords

  • T1-2N0 ER+ invasive
  • biopsy
  • upfront lumpectomy
03

In context

Breast Neoplasms

14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.

This study's planned enrollment of 45 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

This is the only study on the registry with Alice Chung as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Women age ≥ 45
  • Clinical T1-2N0 ER+ invasive breast cancer
  • US detected proven axillary nodal disease
  • Written obtained from subject and ability for subject to comply with the requirements of the study.

Exclusion criteria

Exclusion Criteria:

  • Palpable nodes on physical exam
  • Her2+ or ER- invasive breast cancer
  • Extranodal extension > 3 mm on nodal
  • More than 2 suspicious nodes on preoperative imaging
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Single Arm

    Procedure: Breast Surgery (BCS or mastectomy) with TAD/SNB · Radiation: Adjuvant Radiation Therapy

Interventions

  • ProcedureBreast Surgery (BCS or mastectomy) with TAD/SNB

    Breast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy

  • RadiationAdjuvant Radiation Therapy

    Breast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy

06

What researchers measure

Primary outcomes

  1. Regional recurrence rate

    Regional recurrence rate is defined as the percentage of patients who experience a regional recurrence during follow-up period.

    Time frame: 5 Years

Secondary outcomes

  1. Local recurrence rate

    Local recurrence rate is defined as the percentage of subjects who experience a local recurrence during follow-up period.

    Time frame: 5 Years

  2. Disease-free survival (DFS)

    Disease-free survival (DFS) is defined as the length of time after targeted axillary dissection (TAD) that the subject survives without any signs or symptoms of breast cancer.

    Time frame: 5 Years

  3. Breast cancer specific survival (BCSS) rate

    Breast cancer specific survival (BCSS) rate is defined as the percentage of subjects who have not died from breast cancer during follow-up period

    Time frame: 5 Years

  4. Overall survival (OS)

    Overall survival (OS) is defined as the length of time from targeted axillary dissection (TAD) that the subjects are still alive.

    Time frame: 5 Years

07

Study locations

3 of 3 sites recruiting
  • Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
    Los Angeles, California 90048, United States
    Recruiting
    • Clinical Trial Recruitment Navigator · ContactGroupCancerTrialInformation@cshs.org · 310-423-5842
    • Scott Karlan, MD · Sub investigator
    • Armando Giuliano, MD · Sub investigator
    • Catherine Dang, MD · Sub investigator
    • Farin Amersi, MD · Sub investigator
    • Alice Chung, MD · Principal investigator
    • Marissa Boyle, MD · Sub investigator
    • Kjirsten Carlson, MD · Sub investigator
    • Stephen Shiao, MD PhD · Sub investigator
    • Julie Jang, MD · Sub investigator
    • Michele Burnison, MD · Sub investigator
    • Amin Mirhadi, MD · Sub investigator
  • CS Cancer at Huntington Cancer Center
    Pasadena, California 91105, United States
    Recruiting
    • · Contact424-314-0177
    • Jeannie Shen, MD · Sub investigator
    • Amy Polverini, MD · Sub investigator
    • Alicia Terando, MD · Sub investigator
  • CS Cancer at Valley Oncology Medical Group
    Tarzana, California 91356, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2024 (actual). Primary completion is estimated for Apr 2031, 84 months after the start.

Of 1,070 non-industry phase 2 interventional studies under Breast Neoplasms, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 87. This study's planned 84 months is above that.

Counting every sponsor, half of 1,302 studies reached it within 51 months; a quarter within 30 and three quarters within 82.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2023
First posted
Oct 23, 2023
StartActual
Apr 7, 2024
Primary completionEst.
Apr 2031
CompletionEst.
Apr 2031
Last update
Aug 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06092892
Lead sponsor
Alice Chung
Responsible party
Alice Chung (Sponsor-Investigator, Cedars-Sinai Medical Center) — Sponsor-investigator
First posted
Oct 23, 2023
Start date
Apr 7, 2024
Primary completion
Apr 2031 (estimated)
Completion
Apr 2031 (estimated)
Last update
Aug 10, 2026

Study contacts

Clinical Trial Navigator
Contact
GroupCancerTrialInformation@cshs.org
310-423-5842
Alice Chung, MD
principal investigator · Cedars-Sinai Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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