Breast Cancer Stage II, Breast Cancer Stage III
Conditions
Brief summary
The objective of the study is to serve as a correlative study for patients enrolled on the RadCOMP trial (NCT02603341), a randomized phase III study of stage II and III breast cancer patients treated with either conventional photon radiation or proton beam radiation
Interventions
None listed
Sponsors
Massachusetts General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eligible for and scheduled to receive radiation therapy on Radiation Therapy Oncology Group (RTOG) Trial 3510 (Pragmatic Phase III Randomized Trial of Proton vs Photon Therapy for Patients with Non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial). (NCT02603341) * Ability to understand and the willingness to sign a study-specific written informed consent document
Exclusion criteria
* There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Global Longitudinal Strain (GLS) | Baseline, 6 Months | Comparison of the change in GLS between conventional radiation and proton beam radiation groups. Participants who decrease their GLS by at least 2% 6-8 months following radiation therapy will be considered to demonstrate a significant decrement in GLS. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Left Ventricular Ejection Fraction (LVEF) Using Echocardiography | Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment | Comparison of the change in LVEF between conventional radiation and proton beam radiation groups. Reduced cardiac function is defined as an ejection fraction \<50%. |
| Radiation-induced Lung Parenchymal Changes Using CT Imaging | Baseline, 3,6,12, months post treatment | Radiation-induced lung parenchymal changes will be assess with non-contrast enhanced computerized tomography (CT) scans and incidence will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. Among patients who do not have any changes detected, death and disease progression will be considered as competing risks. |
| Incidence of Thyroid Dysfunction | Baseline, end of treatment (approximately 10 weeks), then 12, 24, 36, and 60 months post treatment | Incidence of thyroid insufficiency will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. In the absence of thyroid dysfunction, death and disease progression will be considered as competing risks. |
| Incidence of Ipsilateral Arm Lymphedema | Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment | Incidence of ipsilateral arm lymphedema will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. |
| Severity of Ipsilateral Arm Lymphedema | Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment | Serial arm measurements may be analyzed using mixed effects model to compare the severity of ipsilateral arm lymphedema over time between the radiation groups. |
| Ipsilateral Breast/Chest Wall Cosmesis | Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment | Breast cosmesis will be assessed with characteristics graded on a four-point scale. Assessments will be performed by a trained nurse/nurse practitioner using the European Organization for Research and Treatment of Cancer (EORTC) Cosmetic Rating System for Breast Cancer. Incidence of adverse cosmesis (2=fair or 3=poor score) will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test. Among patients without adverse breast cosmesis, death and disease progression will be considered as competing risks. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRachel Jimenez, MD
Massachusetts General Hospital
Outcome results
None listed