Clinical trial · Observational
Breast Cancer Lung Late Effects
Early Markers of Subclinical Pulmonary Vascular Radiation Toxicity in Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radiation Injury | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Computed Tomography (CT) Scan | Procedure | — | UNRESOLVED |
| Proton beam radiation therapy. | Radiation | — | UNRESOLVED |
| Pulmonary Function Test (PFT) | Procedure | — | UNRESOLVED |
| X-ray based radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Proton beam radiation therapy
- description
- The participants in this group will be receiving proton therapy of the affected breast and chest wall as part of their standard of care. In addition, a Computed Tomography (CT) Scan of the chest wall will be performed, and pulmonary function test (PFT).
- interventionNames
- Radiation: Proton beam radiation therapy.
- Procedure: Computed Tomography (CT) Scan
- Procedure: Pulmonary Function Test (PFT)
- label
- X-ray based radiation therapy
- description
- The participants in this group will be receiving X-ray radiation therapy of the affected breast and chest wall as part of their standard of care. In addition, a Computed Tomography (CT) Scan of the chest wall will be performed, and pulmonary function test (PFT).
- interventionNames
- Radiation: X-ray based radiation therapy
- Procedure: Computed Tomography (CT) Scan
- Procedure: Pulmonary Function Test (PFT)
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion 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. Exclusion 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.
References
Publications (0)
Data not yet available