RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-07
Study Completion:2031-04
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06092892

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women age ≥ 45
  2. * Clinical T1-2N0 ER+ invasive breast cancer
  3. * US detected biopsy proven axillary nodal disease
  4. * Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
  1. * Palpable nodes on physical exam
  2. * Her2+ or ER- invasive breast cancer
  3. * Extranodal extension \> 3 mm on nodal biopsy
  4. * More than 2 suspicious nodes on preoperative imaging

Contacts and Locations

Study Contact

Clinical Trial Navigator
CONTACT
3104232133
cancer.trial.info@cshs.org

Principal Investigator

Alice Chung, MD
PRINCIPAL_INVESTIGATOR
Cedars-Sinai Medical Center

Study Locations (Sites)

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California, 90048
United States
CS Cancer at Huntington Cancer Center
Pasadena, California, 91105
United States
CS Cancer at Valley Oncology Medical Group
Tarzana, California, 91356
United States

Collaborators and Investigators

Sponsor: Alice Chung

  • Alice Chung, MD, PRINCIPAL_INVESTIGATOR, Cedars-Sinai Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-07
Study Completion Date2031-04

Study Record Updates

Study Start Date2024-04-07
Study Completion Date2031-04

Terms related to this study

Keywords Provided by Researchers

  • T1-2N0 ER+ invasive
  • biopsy
  • upfront lumpectomy

Additional Relevant MeSH Terms

  • Breast Cancer
  • Axillary Nodal Disease
  • Female Breast Cancer
  • Axilla; Breast
  • Mastectomy; Lymphedema
  • Tumor, Breast