CompletedNot applicableNCT02725840
Official study title

Breast Cancer Lung Late Effects

Study summary

Through improved early detection and treatment, the number of long term breast cancer survivors continues to increase. There are now 2.8 million breast cancer survivors in the U.S. Florida alone adds over 9,000 women to the survivorship pool each year. Most receive radiation treatment (RT) of the affected breast and chest wall to reduce risk of recurrence. Even with advanced radiation techniques for dose conformality to minimize exposure of the highly sensitive lung, 14% of breast cancer patients treated with radiation develop clinical pulmonary toxicity, with 4% overall experiencing high grade clinical toxicity. Early diagnosis and intervention to mitigate lung radiation toxicity is increasingly important for the long term care of these survivors. The investigators' goal is to better identify breast cancer patients at high risk for experiencing severe pulmonary toxicity requiring medical intervention, provide a means to identify toxicity early on, and tailor treatment and/or early intervention on a per-patient basis.

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Key things to know

Main goalNot specified

This describes the study’s primary purpose.

What is being studiedProton beam radiation therapy. and X-ray based radiation therapy

Plus 2 other study approaches.

Who it may be forRecurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Aug 22, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Observational

Where is it offered?2 U.S. locations

Locations may change over time.

Who runs it?University of Florida

Study sponsor

01
Study overview

What this study is about

Purpose
Not specified
Study type
Observational
Phase
Not applicable
Sponsor
University of Florida
Interventions being studied
Radiation: Proton beam radiation therapy.; Radiation: X-ray based radiation therapy; Procedure: Computed Tomography (CT) Scan; Procedure: Pulmonary Function Test (PFT)
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Women who are at least 18 years of age.
  • Women with Stage II or higher primary breast cancer and who are scheduled to receive conventional X-ray RT (n=30) or proton therapy (n=25) to the breast and chest wall.
Reasons someone may not be able to joinExclusion criteria
  • Patients not willing or able to submit to repeat chest CT scans and blood draws.
  • Pregnant women.
  • Patients who have previously had radiation treatment where any portion of the lung received greater than 5 Gy of radiation exposure.
  • Women with bilateral breast cancer or metastatic disease to sites near the chest where additional radiation exposure to any portion of the lung of greater than 5 Gy is anticipated.
  • Women with allergic reaction to all common CT contrast agents.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Department of Radiation Oncology Davis Cancer PavilionGainesville, Florida
  • University of Florida Health Proton Therapy InstituteJacksonville, Florida

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Aug 22, 2024. Always confirm current availability with the study team.

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