Upfront treatment for breast cancer with nodal metastases
Official title: IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Clinical T1-2N0 ER+ Her2- Breast Cancer With Ultrasound Detected Nodal Metastases
Run by Cedars-Sinai Medical Center · NCT06092892 · Data updated 2026-11-12
This study is testing if starting treatment with surgery and targeted therapy can help women with early-stage breast cancer that has spread to their lymph nodes live longer and have fewer recurrences.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 45 Years and up |
| Sex | Women only |
| Enrollment | 45 (estimated) |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 3 sites (Los Angeles, California and 2 other locations) |
| Status | Recruiting |
| Started | April 7, 2024 |
| Main results expected | April 2031 |
| Study ends | April 2031 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT06092892 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 45 and older with clinical T1-2N0 ER+ invasive breast cancer and biopsy-proven axillary nodal disease.
✕Probably not a fit
Patients with palpable nodes, Her2+ or ER- invasive breast cancer, or significant extranodal extension may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the recurrence rates and survival outcomes in women with clinical T1-2N0 ER+/Her2- invasive breast cancer who have biopsy-proven nodal disease. Participants will undergo upfront lumpectomy or mastectomy combined with targeted axillary dissection (TAD) followed by adjuvant therapy. The study is a prospective, single-arm phase II trial, where patient, tumor, and treatment data will be meticulously documented to assess the effectiveness of the intervention.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and reduced recurrence in patients with breast cancer and nodal metastases.
How similar studies have gone: Other studies have shown promising results with similar approaches in treating breast cancer with nodal involvement, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
Where it's running
-
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, United States Recruiting -
CS Cancer at Huntington Cancer Center
Pasadena, California, United States Recruiting -
CS Cancer at Valley Oncology Medical Group
Tarzana, California, United States Recruiting
Study contacts
- Principal investigator: Alice Chung, MD — Cedars-Sinai Medical Center
- Study coordinator: Clinical Trial Navigator
- Email: GroupCancerTrialInformation@cshs.org
- Phone: 310-423-5842
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.