IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Breast Cancer With Nodal Metastases

Breast Cancer Clinical Trial

Official title:

IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients With Clinical T1-2N0 ER+ Her2- Breast Cancer With Ultrasound Detected Nodal Metastases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06092892
• Other study ID #: IIT2023-09-Chung-UpfrontTAD
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2024
• Est. completion date: April 2031

Study information

• Verified date: April 2024
• Source: Cedars-Sinai Medical Center
• Contact: Clinical Trial Navigator
• Phone: 3104232133
• Email: cancer.trial.info[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: April 2031
• Est. primary completion date: April 2031
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Axilla; Breast
• Breast Cancer
• Breast Neoplasms
• Female Breast Cancer
• Lymphedema
• Mastectomy; Lymphedema

Intervention

Procedure:
• Breast Surgery (BCS or mastectomy) with TAD/SNB
Breast surgery (BCS or mastectomy) with TAD/SNB & Adjuvant Radiation therapy

Radiation:
• Adjuvant Radiation Therapy
Breast surgery (BCS or mastectomy) with TAD/SNB & Adjuvant Radiation therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alice Chung

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Regional recurrence rate	Regional recurrence rate is defined as the percentage of patients who experience a regional recurrence during follow-up period.	5 Years
Secondary	Local recurrence rate	Local recurrence rate is defined as the percentage of subjects who experience a local recurrence during follow-up period.	5 Years
Secondary	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.	5 Years
Secondary	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
Secondary	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