Breast CancerPhase 2NCT06092892
IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases
A Phase 2 study testing Breast Surgery (BCS or mastectomy) with TAD/SNB and Adjuvant Radiation Therapy in people with Breast Cancer and Axillary Nodal Disease, run by Alice Chung at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Breast Cancer, Axillary Nodal Disease, Female Breast Cancer
- What is being tested?
- Breast Surgery (BCS or mastectomy) with TAD/SNB and Adjuvant Radiation Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 3 sitesUnited States
- Study dates
- 7 Apr 2024to Apr 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women age ≥ 45
- Clinical T1-2N0 ER+ invasive breast cancer
- US detected biopsy proven axillary nodal disease
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Who cannot join
- Palpable nodes on physical exam
- Her2+ or ER- invasive breast cancer
- Extranodal extension > 3 mm on nodal biopsy
- More than 2 suspicious nodes on preoperative imaging
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048
Clinical Trial Recruitment Navigator, 310-423-5842, GroupCancerTrialInformation@cshs.org
Scott Karlan, MD
- Recruiting
CS Cancer at Huntington Cancer Center
Pasadena, California, 91105
424-314-0177
Jeannie Shen, MD
- Recruiting
CS Cancer at Valley Oncology Medical Group
Tarzana, California, 91356
Vanessa Vasco, Vanessa.Vasco@cshs.org
Lauren DeStefano, MD
About this study
Official title: IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Clinical T1-2N0 ER+ Her2- Breast Cancer With Ultrasound Detected Nodal Metastases
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.
- Conditions
- Breast Cancer, Axillary Nodal Disease, Female Breast Cancer, Axilla; Breast, Mastectomy; Lymphedema, Tumor, Breast
- Being tested
- Breast Surgery (BCS or mastectomy) with TAD/SNB, Adjuvant Radiation Therapy
- Keywords
- T1-2N0 ER+ invasive, biopsy, upfront lumpectomy
- Medical subject headings
- Breast Neoplasms, Lymphedema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast Surgery (BCS or mastectomy) with TAD/SNBProcedure or surgery
Breast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy
Adjuvant Radiation TherapyRadiation
Breast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Not described Receives: Procedure: Breast Surgery (BCS or mastectomy) with TAD/SNB; Radiation: Adjuvant Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional recurrence rate
Regional recurrence rate is defined as the percentage of patients who experience a regional recurrence during follow-up period.
Measured: 5 Years
Secondary outcomes (4)
Local recurrence rate
Local recurrence rate is defined as the percentage of subjects who experience a local recurrence during follow-up period.
Measured: 5 Years
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.
Measured: 5 Years
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
Measured: 5 Years
Overall survival (OS)
Overall survival (OS) is defined as the length of time from targeted axillary dissection (TAD) that the subjects are still alive.
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start7 Apr 2024
- Primary completionApr 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single arm
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alice Chung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alice Chung, Cedars-Sinai Medical Center
- Investigators
- Alice Chung, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06092892
- Sponsor's protocol ID
- IIT2023-09-Chung-UpfrontTAD
- Status last verified
- Aug 2026
- First submitted
- 16 Oct 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Clinical T1-2N0 ER+ Her2- Breast Cancer With Ultrasound Detected Nodal Metastases
- ClinicalTrials.gov ID
- NCT06092892
- Acronym / sponsor ID
- IIT2023-09-Chung-UpfrontTAD
- Conditions
- Breast Cancer, Axillary Nodal Disease, Female Breast Cancer, Axilla; Breast, Mastectomy; Lymphedema, Tumor, Breast
- Keywords
- T1-2N0 ER+ invasive, biopsy, upfront lumpectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Alice ChungUniversity, hospital or other
- Study start
- 7 Apr 2024 (actual)
- Primary completion
- Apr 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open label, single arm
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Procedure: Breast Surgery (BCS or mastectomy) with TAD/SNB, Radiation: Adjuvant Radiation Therapy |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women age ≥ 45
- Clinical T1-2N0 ER+ invasive breast cancer
- US detected biopsy proven axillary nodal disease
- Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Key exclusion criteria (4 listed)
- Palpable nodes on physical exam
- Her2+ or ER- invasive breast cancer
- Extranodal extension > 3 mm on nodal biopsy
- More than 2 suspicious nodes on preoperative imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast Surgery (BCS or mastectomy) with TAD/SNBBreast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy | Procedure or surgery | Single Arm |
| Adjuvant Radiation TherapyBreast surgery (BCS or mastectomy) with TAD/SNB \& Adjuvant Radiation therapy | Radiation | Single Arm |
Primary outcome
Regional recurrence rate
Time frame: 5 Years
Regional recurrence rate is defined as the percentage of patients who experience a regional recurrence during follow-up period.
4 secondary outcomes
Local recurrence rate
Time frame: 5 Years
Disease-free survival (DFS)
Time frame: 5 Years
Breast cancer specific survival (BCSS) rate
Time frame: 5 Years
Overall survival (OS)
Time frame: 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alice Chung, MD principal investigator
Cedars-Sinai Medical Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Breast Surgery (BCS or mastectomy) with TAD/SNB and Adjuvant Radiation Therapy in people with Breast Cancer and Axillary Nodal Disease, run by Alice Chung at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trial Navigator (310-423-5842, GroupCancerTrialInformation@cshs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Regional recurrence rate (time frame: 5 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.