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NCT06092892 | RECRUITING | Breast Cancer


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

Alice Chung

Information provided by (Responsible Party):

Alice Chung

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.

Condition or disease

Breast Cancer

Axillary Nodal Disease

Female Breast Cancer

Axilla; Breast

Mastectomy; Lymphedema

Tumor, Breast

Intervention/treatment

Breast Surgery (BCS or mastectomy) with TAD/SNB

Adjuvant Radiation Therapy

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 45 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : IIT2023-09-Chung-UpfrontTAD: Upfront TAD/SNB in Patients with Clinical T1-2N0 ER+ Her2- Breast Cancer with Ultrasound Detected Nodal Metastases
Actual Study Start Date : 2024-04-07
Estimated Primary Completion Date : 2031-04
Estimated Study Completion Date : 2031-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 45 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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

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

Location Details

NCT06092892


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


RECRUITING

United States, California

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute

Los Angeles, California, United States, 90048

RECRUITING

United States, California

CS Cancer at Huntington Cancer Center

Pasadena, California, United States, 91105

RECRUITING

United States, California

CS Cancer at Valley Oncology Medical Group

Tarzana, California, United States, 91356

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