What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as chemotherapy, radiotherapy, and endocrine therapy, have various side effects. Chemotherapy can lead to alopecia, headaches, scalp pain, and feelings of cold. Radiotherapy may cause acute toxic effects like skin irritation and fatigue. Endocrine therapies, such as tamoxifen and aromatase inhibitors, can result in bone density loss, fractures, and cardiovascular risks. These treatments aim to manage and reduce the risk of breast cancer recurrence but come with a range of potential adverse effects that should be discussed with a healthcare provider.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that involve biomarker detection and targeted therapies. Notable approvals include hormone receptor modulators like tamoxifen, aromatase inhibitors such as letrozole and anastrozole, and HER2-targeted therapies like trastuzumab. Additionally, CDK4/6 inhibitors like palbociclib have been approved for hormone receptor-positive, HER2-negative breast cancer. These treatments focus on specific biomarkers to tailor therapy, similar to the approach being studied with Nipple Aspirate Fluid for early detection of breast cancer.

What other types of research exist?

Promising novel alternatives to Nipple Aspirate Fluid for detecting breast cancer biomarkers include: 1) High-resolution 3-Tesla MRI, which offers improved accuracy in detecting breast lesions. 2) Plasma-derived protein-metabolite multiplexed panels, which have shown potential in early-stage cancer detection. 3) Multi-analyte blood tests that combine various biomarkers for higher detection rates. These methods provide non-invasive, accurate, and early detection options for breast cancer patients.

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Nipple Aspirate Fluid Detection for Breast Cancer

N/A

Waitlist Available

Led By William Carson, MD

Research Sponsored by Ohio State University Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial studies collecting nipple fluid to detect breast cancer in women. The fluid is tested for cancer-related proteins using a new technology, which may find cancer earlier than current methods like mammograms.

Who is the study for?

This trial is for women over a year removed from pregnancy or lactation, with current breast cancer diagnosis or healthy subjects without any cancer. Healthy participants must have had a recent non-suspicious breast exam/mammogram. Exclusions include men, those pregnant/lactating within the last year, and anyone with cancers other than breast.

What is being tested?

The study is examining nipple aspirate fluid to see if it's more effective at early detection of breast cancer compared to traditional screening methods like mammograms and clinical exams.

What are the potential side effects?

Since this trial involves collecting fluid samples and not testing a drug or therapy, there are minimal side effects expected beyond potential discomfort or bruising from the aspiration procedure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biomarkers expression levels

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (nipple aspiration fluid)Experimental Treatment2 Interventions

Participants and healthy volunteers undergo collection of nipple aspirate fluid from both breasts.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Biospecimen Collection

2004

Completed Phase 3

~2030

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments work through various mechanisms to target and eliminate cancer cells. Surgery physically removes the tumor, while radiation uses high-energy waves to destroy cancerous tissue. Chemotherapy involves drugs that kill rapidly dividing cells, including cancer cells. Hormone therapy blocks hormones like estrogen that fuel certain breast cancers, and targeted therapy uses drugs to specifically target cancer cell molecules, such as HER2 proteins. Understanding these mechanisms is crucial for patients as it helps in selecting the most effective treatment plan and managing side effects. Early detection methods like nipple aspirate fluid can identify biomarkers, potentially allowing for earlier and more personalized treatment interventions.

Gene-expression signatures to inform neoadjuvant treatment decision in HR+/HER2- breast cancer: Available evidence and clinical implications.Identification and meta-analysis of a small gene expression signature for the diagnosis of estrogen receptor status in invasive ductal breast cancer.