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

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.

Conditions

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute, Los Angeles, California, United States, 90048

Pasadena

CS Cancer at Huntington Cancer Center, Pasadena, California, United States, 91105

Tarzana

CS Cancer at Valley Oncology Medical Group, Tarzana, California, United States, 91356

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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

Ages Eligible for Study

45 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Alice Chung,

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

Study Record Dates

2031-04