RightFit
RecruitingPhase 2

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
45 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tracks how often breast cancer comes back and how long patients live after breast surgery with targeted lymph node removal, followed by more treatment. It is for women age 45 or older with breast cancer that uses estrogen to grow (ER-positive) and is HER2-negative, with cancer in underarm lymph nodes found by imaging and confirmed by a tissue sample.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 45 or older.
  • ER-positive invasive breast cancer, meaning it uses estrogen to grow and has spread into nearby breast tissue.
  • Cancer stage T1–2N0: the breast tumor is no larger than 5 cm, and no lymph node spread is found on a physical exam.
  • Cancer in underarm lymph nodes found by ultrasound and confirmed by a biopsy, or tissue sample.
  • Able to give written consent and follow the study requirements.

Who can't join

  • Lymph nodes that can be felt during a physical exam.
  • Breast cancer that is HER2-positive or ER-negative.
  • A lymph node biopsy shows cancer growing more than 3 mm beyond the node.
  • More than 2 lymph nodes look suspicious for cancer on imaging before surgery.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (3)

CA