Trial Title:
IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases
NCT ID:
NCT06092892
Condition:
Breast Cancer
Axillary Nodal Disease
Female Breast Cancer
Axilla; Breast
Mastectomy; Lymphedema
Tumor, Breast
Conditions: Official terms:
Breast Neoplasms
Lymphedema
Conditions: Keywords:
T1-2N0 ER+ invasive
biopsy
upfront lumpectomy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Open label, single arm
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Breast Surgery (BCS or mastectomy) with TAD/SNB
Description:
Breast surgery (BCS or mastectomy) with TAD/SNB & Adjuvant Radiation therapy
Arm group label:
Single Arm
Intervention type:
Radiation
Intervention name:
Adjuvant Radiation Therapy
Description:
Breast surgery (BCS or mastectomy) with TAD/SNB & Adjuvant Radiation therapy
Arm group label:
Single Arm
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.
Criteria for eligibility:
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
Gender:
Female
Minimum age:
45 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Address:
City:
Los Angeles
Zip:
90048
Country:
United States
Status:
Recruiting
Contact:
Last name:
Amy Oppenheim
Phone:
310-423-3713
Email:
Amy.Oppenheim@cshs.org
Investigator:
Last name:
Scott Karlan, MD
Email:
Sub-Investigator
Investigator:
Last name:
Armando Giuliano, MD
Email:
Sub-Investigator
Investigator:
Last name:
Catherine Dang, MD
Email:
Sub-Investigator
Investigator:
Last name:
Farin Amersi, MD
Email:
Sub-Investigator
Investigator:
Last name:
Alice Chung, MD
Email:
Principal Investigator
Investigator:
Last name:
Marissa Boyle, MD
Email:
Sub-Investigator
Investigator:
Last name:
Kjirsten Carlson, MD
Email:
Sub-Investigator
Investigator:
Last name:
Stephen Shiao, MD PhD
Email:
Sub-Investigator
Investigator:
Last name:
Julie Jang, MD
Email:
Sub-Investigator
Investigator:
Last name:
Michele Burnison, MD
Email:
Sub-Investigator
Investigator:
Last name:
Amin Mirhadi, MD
Email:
Sub-Investigator
Facility:
Name:
CS Cancer at Huntington Cancer Center
Address:
City:
Pasadena
Zip:
91105
Country:
United States
Status:
Recruiting
Contact:
Phone:
424-314-0177
Investigator:
Last name:
Jeannie Shen, MD
Email:
Sub-Investigator
Investigator:
Last name:
Amy Polverini, MD
Email:
Sub-Investigator
Investigator:
Last name:
Alicia Terando, MD
Email:
Sub-Investigator
Facility:
Name:
CS Cancer at Valley Oncology Medical Group
Address:
City:
Tarzana
Zip:
91356
Country:
United States
Status:
Recruiting
Contact:
Last name:
Vanessa Vasco
Email:
Vanessa.Vasco@cshs.org
Investigator:
Last name:
Lauren DeStefano, MD
Email:
Sub-Investigator
Start date:
April 7, 2024
Completion date:
April 2031
Lead sponsor:
Agency:
Alice Chung
Agency class:
Other
Source:
Cedars-Sinai Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06092892
