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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast Surgery (BCS or mastectomy) with TAD/SNB | Procedure | Breast surgery (BCS or mastectomy) with TAD/SNB & Adjuvant Radiation therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Regional recurrence rate | Regional recurrence rate is defined as the percentage of patients who experience a regional recurrence during follow-up period. | 5 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Local recurrence rate | Local recurrence rate is defined as the percentage of subjects who experience a local recurrence during follow-up period. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Navigator | Contact | 3104232133 | GroupCancerTrialInformation@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Alice Chung, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute | Recruiting | Los Angeles | California | 90048 | United States |
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Open label, single arm
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| Adjuvant Radiation Therapy | Radiation | Breast surgery (BCS or mastectomy) with TAD/SNB & Adjuvant Radiation therapy |
|
| 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 | 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. | 5 Years |
| CS Cancer at Huntington Cancer Center | Recruiting | Pasadena | California | 91105 | United States |
|
| CS Cancer at Valley Oncology Medical Group | Recruiting | Tarzana | California | 91356 | United States |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D015412 | Mastectomy, Segmental |
| D008408 | Mastectomy |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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