RecruitingPhase 2NCT06833502

Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer

Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer Following Neoadjuvant Chemotherapy and Surgery


Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Enrollment

120 participants

Start Date

Feb 24, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the study is to determine the frequency of systemic metastasis in node positive breast cancer following chemotherapy and surgery. Participants will be asked to spend about 6 months in this study. Participants will undergo a computed tomography (CT) screening of the thorax, abdomen, and pelvis at baseline prior to adjuvant radiation therapy and another CT screening of the thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase II study is evaluating whether routine full-body imaging (systemic screening) after surgery should be performed in breast cancer patients who still have cancer in their lymph nodes after receiving pre-surgery chemotherapy (neoadjuvant chemotherapy). The goal is to find out whether this screening helps detect distant spread of cancer early enough to change treatment decisions. **You may be eligible if...** - You are at least 18 years old - You have been diagnosed with breast cancer with known hormone receptor (ER/PR) and HER2 status - You have cancer-positive lymph nodes remaining after completing at least 8 weeks of neoadjuvant chemotherapy and surgery - HER2-positive and triple-negative patients need at least one positive node; HR+/HER2-negative patients need two or more positive nodes after surgery **You may NOT be eligible if...** - You did not complete the required minimum chemotherapy before surgery - You have no lymph node involvement after surgery - Your cancer type does not meet the specific criteria for this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERCT Scan

Participants will undergo a screening CT thorax, abdomen, pelvis at baseline prior to adjuvant radiation therapy and additional screening CT thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.


Locations(1)

Moffitt Cancer Center

Tampa, Florida, United States

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NCT06833502


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