Axilla; Breast, Axillary Nodal Disease, Breast Cancer, Female Breast Cancer, Mastectomy; Lymphedema, Tumor, Breast
Conditions
Keywords
T1-2N0 ER+ invasive, biopsy, upfront lumpectomy
Brief 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.
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
Sponsors
Alice Chung
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open label, single arm
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Regional recurrence rate | 5 Years | Regional recurrence rate is defined as the percentage of patients who experience a regional recurrence during follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence rate | 5 Years | Local recurrence rate is defined as the percentage of subjects who experience a local recurrence during follow-up period. |
| Disease-free survival (DFS) | 5 Years | 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. |
| Breast cancer specific survival (BCSS) rate | 5 Years | Breast cancer specific survival (BCSS) rate is defined as the percentage of subjects who have not died from breast cancer during follow-up period |
| Overall survival (OS) | 5 Years | Overall survival (OS) is defined as the length of time from targeted axillary dissection (TAD) that the subjects are still alive. |
Countries
United States
Contacts
CONTACTClinical Trial Navigator
PRINCIPAL_INVESTIGATORAlice Chung, MD
Cedars-Sinai Medical Center
Outcome results
None listed