Upfront treatment for breast cancer with nodal metastases
IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Clinical T1-2N0 ER+ Her2- Breast Cancer With Ultrasound Detected Nodal Metastases
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 |
| Enrollment | 45 (estimated) |
| Ages | 45 Years and up |
| Sex | Female |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 3 sites (Los Angeles, California and 2 other locations) |
| Trial ID | NCT06092892 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with palpable nodes, Her2+ or ER- invasive breast cancer, or significant extranodal extension may not benefit from this study.
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 performed: Other studies have shown promising results with similar approaches in treating breast cancer with nodal involvement, indicating potential for success.
Eligibility criteria
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 this trial is running
Los Angeles, California and 2 other locations
- 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: 3104232133
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.