Breast Cancer Stage IINCT03270072
The Differential Impact of Proton Beam Irradiation Versus Conventional Radiation on Organs-at-risk in Stage II-III Breast Cancer Patients
An observational study of Breast Cancer Stage II and Breast Cancer Stage III, run by Massachusetts General Hospital at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Breast Cancer Stage II, Breast Cancer Stage III
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2017to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients enrolled at Massachusetts General Hospital on the 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).
Who may be able to join
- 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
Who cannot join
- There are no exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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
- Conditions
- Breast Cancer Stage II, Breast Cancer Stage III
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Photon Therapy | The patients being treated on the Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial (NCT02603341) at Massachusetts General Hospital that were randomized to receive photon therapy. | |
| Proton Therapy | The patients being treated on the Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial (NCT02603341) at Massachusetts General Hospital that were randomized to receive proton therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Global Longitudinal Strain (GLS)
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.
Measured: Baseline, 6 Months
Secondary outcomes (6)
Change in Left Ventricular Ejection Fraction (LVEF) Using Echocardiography
Comparison of the change in LVEF between conventional radiation and proton beam radiation groups. Reduced cardiac function is defined as an ejection fraction <50%.
Measured: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
Radiation-induced Lung Parenchymal Changes Using CT Imaging
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.
Measured: Baseline, 3,6,12, months post treatment
Incidence of Thyroid Dysfunction
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.
Measured: Baseline, end of treatment (approximately 10 weeks), then 12, 24, 36, and 60 months post treatment
Incidence of Ipsilateral Arm Lymphedema
Incidence of ipsilateral arm lymphedema will be estimated in each radiation group by the cumulative incidence function and compared using Gray's test.
Measured: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
Severity of Ipsilateral Arm Lymphedema
Serial arm measurements may be analyzed using mixed effects model to compare the severity of ipsilateral arm lymphedema over time between the radiation groups.
Measured: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
Ipsilateral Breast/Chest Wall Cosmesis
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.
Measured: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start26 Oct 2017
- Primary completion31 Dec 2024
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer Stage IIStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rachel Beth Jimenez, Massachusetts General Hospital
- Investigators
- Rachel Jimenez, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270072
- Sponsor's protocol ID
- 17-031
- Status last verified
- Aug 2026
- First submitted
- 13 Jun 2017
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Differential Impact of Proton Beam Irradiation Versus Conventional Radiation on Organs-at-risk in Stage II-III Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03270072
- Acronym / sponsor ID
- 17-031
- Conditions
- Breast Cancer Stage II, Breast Cancer Stage III
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 26 Oct 2017 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photon Therapy | – | –The patients being treated on the Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial (NCT02603341) at Massachusetts General Hospital that were randomized to receive photon therapy. |
| Proton Therapy | – | –The patients being treated on the Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial (NCT02603341) at Massachusetts General Hospital that were randomized to receive proton therapy |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled at Massachusetts General Hospital on the 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).
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- There are no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Global Longitudinal Strain (GLS)
Time frame: 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.
6 secondary outcomes
Change in Left Ventricular Ejection Fraction (LVEF) Using Echocardiography
Time frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
Radiation-induced Lung Parenchymal Changes Using CT Imaging
Time frame: Baseline, 3,6,12, months post treatment
Incidence of Thyroid Dysfunction
Time frame: Baseline, end of treatment (approximately 10 weeks), then 12, 24, 36, and 60 months post treatment
Incidence of Ipsilateral Arm Lymphedema
Time frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
Severity of Ipsilateral Arm Lymphedema
Time frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
Ipsilateral Breast/Chest Wall Cosmesis
Time frame: Baseline, end of treatment (approximately 10 weeks), then 6, 12, 24, 36, and 60 months post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Jimenez, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Stage II and Breast Cancer Stage III, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Global Longitudinal Strain (GLS) (time frame: Baseline, 6 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.