Breast CancerNCT05912231
Ultrahypofractionation and Normal Tissue Toxicity
A study testing Accelerated Proton Beam Radiation Therapy (PBT) and Accelerated Photon Radiation Therapy (XRT) in people with Breast Cancer and Breast Cancer Female, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This research is being done to see if proton beam radiation therapy (PBT) results in fewer changes to a participant's heart measured with MRI-imaging than conventional or "photon" radiation therapy (XRT) for participants with non-metastatic left sided breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Female, Breast Cancer Stage II
- What is being tested?
- Accelerated Proton Beam Radiation Therapy (PBT) and Accelerated Photon Radiation Therapy (XRT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2023to 31 Dec 2026
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥18 years of age
- Non-metastatic Breast Cancer patients who are scheduled to receive conventional left-sided or bilateral breast/chest wall RT inclusive of treatment to the internal mammary lymph nodes (IMNs)
- Prior chemotherapy is permitted
- Ability to understand and the willingness to sign a written informed consent document
- No contraindication to MRI
- Patients with right-sided breast cancer or patients with left-sided patients not requiring treatment to the IMNs, but where cardiac anatomy is determined to be unfavorable by the study PI, will be considered eligible.
Who cannot join
- Person who is pregnant or breastfeeding.
- Patients receiving any other investigational agent will not be excluded from study eligibility, unless the patient is already enrolled in an interventional study evaluating cardiac toxicity. No cytotoxic therapy or radiotherapy may be used during radiation therapy.
- Contra-indication to gadolinium contrast (e.g., chronic kidney disease)
- Contra-indication to radiotherapy (e.g., scleroderma, p53 mutation)
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215
About this study
Official title: Proton Versus Photon Ultrahypofractionated Radiation Therapy and Its Impact on Normal Tissue
This research is being done to see if proton beam radiation therapy (PBT) results in fewer changes to a participant's heart measured with MRI-imaging than conventional or "photon" radiation therapy (XRT) for participants with non-metastatic left sided breast cancer.
The names of the two study groups in this research study are:
- Proton Radiation Therapy (PBT)
- Conventional or "Photon" Radiation Therapy (XRT)
Read the detailed description
This is a randomized phase II trial comparing participants with stage II-III breast cancer treated with accelerated Proton Beam Radiation Therapy (PBT) versus accelerated conventional photon radiation therapy (XRT) inclusive of the regional lymph nodes.
Participants will be randomized into one of two study groups: proton beam radiation therapy versus photon radiation therapy. Randomization means that participants are put into a group by chance.
Study procedures includes screening for eligibility, study treatment visits, Cardiac Magnetic Resonance Imaging (MRI), blood tests, and questionnaires.
The National Cancer Institute, American Society of Clinical Oncology, and Claflin Grant are supporting this research by providing funding for the research study.
- Conditions
- Breast Cancer, Breast Cancer Female, Breast Cancer Stage II, Breast Cancer Stage III, Myocardial Fibrosis
- Being tested
- Accelerated Proton Beam Radiation Therapy (PBT), Accelerated Photon Radiation Therapy (XRT)
- Keywords
- Radiation Therapy, Photon Radiation Therapy, XRT, Proton Beam Radiation Therapy, PBT, Breast Cancer, Breast Cancer Female, Breast Cancer Stage II, Breast Cancer Stage III, Myocardial Fibrosis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated Proton Beam Radiation Therapy (PBT)Radiation
per protocol
Accelerated Photon Radiation Therapy (XRT)Radiation
per protocol
| Study group | Role | What they receive |
|---|---|---|
| Accelerated Proton Beam Radiation Therapy (PBT) Group | Experimental | Participants will be randomized 1:1 to XRT group and stratified by receipt of chemotherapy and cardiac risk factors and will complete:
* Cardiac MRI and blood tests within 1 month prior to start of radiation therapy.
* Radiation therapy 1x daily for 5 days over 1 week.
* End of radiation therapy visit with blood tests.
* 6 month follow up visit with cardiac MRI, blood tests, questionnaires, and photographic imaging.
* 12 month follow up visit with questionnaires and photographic imaging. Receives: Radiation: Accelerated Proton Beam Radiation Therapy (PBT) |
| Accelerated Photon Radiation Therapy (XRT) Group | Experimental | Participants will be randomized 1:1 to XRT group and stratified by receipt of chemotherapy and cardiac risk factors and will complete:
* Cardiac MRI and blood tests within 1 month prior to start of radiation therapy.
* Radiation therapy 1x daily for 5 days over 1 week.
* End of radiation therapy visit with blood tests.
* 6 month follow up visit with cardiac MRI, blood tests, questionnaires, and photographic imaging.
* 12 month follow up visit with questionnaires and photographic imaging. Receives: Radiation: Accelerated Photon Radiation Therapy (XRT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Myocardial Fibrosis from Baseline in Proton Beam Radiation Therapy (PBT)
The primary outcome is to determine whether participants who receive accelerated PBT show no increase in myocardial fibrosis on Cardiac MRI (CMR) compared to an estimated 4% increase in extracellular matrix volume fraction (ECV) in participants who receive accelerated XRT. CMR will be performed using a 3T system (Skyra, Siemens). The T1 phase on MRI will be used to measure ECV.
Measured: Up to 7 months (pre-treatment period to 6 month follow up)
Secondary outcomes (4)
Change in Global Longitudinal Strain (GLS) on CMR from Baseline
GLS will be measured using feature tracking from the Steady-state free precession (SSFP) MRI cine images (Medis Suite, Leiden).
Measured: Up to 7 months (pre-treatment period to 6 month follow up)
Stability of Cardiac Biomarkers from Baseline
Cardiac Biomarkers will be measured using enzyme-linked immunoassay (ELISA).
Measured: Up to 7 months (pre-treatment period to 6 month follow up)
Body Image Evaluation
Assessed by photographic imaging of the breast, chest wall and reconstructed breast, the Breast Q: Mastectomy Module (Postoperative) 2.0, the Breast Q: Reconstruction Module (Postoperative) 2.0, and the Breast-Q: Breast Conserving Therapy Module (Postoperative) 2.0 questionnaires which are rigorous patient-report outcome measures. Modules grade Quality of Life (QOL) and Satisfaction Domains related to post-operative care and experiences. All BREAST-Q scales are transformed into scores that range from 0-100. T. A higher score means greater satisfaction or better QOL (depending on the scale).
Measured: Up to 13 months (pre-treatment period to 12 month follow up)
Change in Shoulder Function from Baseline
Assessed by the Thoracic Focused Assessment with Sonography for Trauma, Triage, and Tracking (TFAST), the Penn Shoulder Scale (PSS), and the Disabilities of the Arm, Shoulder and Hand (DASH) Shoulder Function Scale. TFAST is an objective and highly reproducible functional assessment tool of the arm and shoulder. The PSS is a patient-reported outcome tool which provides a shoulder-specific metric and distinguishes between finer levels of functioning. Scores range from 0 to 100 with a score of 100 indicating low pain, high satisfaction, and high function. DASH is a 30-item, validated, patient-reported scale that captures upper extremity functionality and mobility and maintains high construct validity and responsiveness in the breast cancer population. Questions are graded on a Likert scale with scores ranging from "1" Strongly Disagree to "5" Strongly Agree, where a cumulative score of 0 is graded no disability and 100 is most severe disability.
Measured: Up to 13 months (pre-treatment period to 12 month follow up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start15 Aug 2023
- Primary completion31 Dec 2026 (estimated)
- 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 CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Society of Clinical Oncology
- 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
- NCT05912231
- Sponsor's protocol ID
- 23-182
- Other IDs
- P01CA261669
- Status last verified
- Nov 2025
- First submitted
- 12 Jun 2023
- Last updated
- 13 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proton Versus Photon Ultrahypofractionated Radiation Therapy and Its Impact on Normal Tissue
- ClinicalTrials.gov ID
- NCT05912231
- Acronym / sponsor ID
- 23-182
- Conditions
- Breast Cancer, Breast Cancer Female, Breast Cancer Stage II, Breast Cancer Stage III, Myocardial Fibrosis
- Keywords
- Radiation Therapy, Photon Radiation Therapy, XRT, Proton Beam Radiation Therapy, PBT, Breast Cancer, Breast Cancer Female, Breast Cancer Stage II
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Society of Clinical Oncology
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jun 2023 (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.
This research is being done to see if proton beam radiation therapy (PBT) results in fewer changes to a participant's heart measured with MRI-imaging than conventional or "photon" radiation therapy (XRT) for participants with non-metastatic left sided breast cancer.
The names of the two study groups in this research study are:
- Proton Radiation Therapy (PBT)
- Conventional or "Photon" Radiation Therapy (XRT)
Detailed description
This is a randomized phase II trial comparing participants with stage II-III breast cancer treated with accelerated Proton Beam Radiation Therapy (PBT) versus accelerated conventional photon radiation therapy (XRT) inclusive of the regional lymph nodes.
Participants will be randomized into one of two study groups: proton beam radiation therapy versus photon radiation therapy. Randomization means that participants are put into a group by chance.
Study procedures includes screening for eligibility, study treatment visits, Cardiac Magnetic Resonance Imaging (MRI), blood tests, and questionnaires.
The National Cancer Institute, American Society of Clinical Oncology, and Claflin Grant are supporting this research by providing funding for the research study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerated Proton Beam Radiation Therapy (PBT) Group | Experimental | Radiation: Accelerated Proton Beam Radiation Therapy (PBT)Participants will be randomized 1:1 to XRT group and stratified by receipt of chemotherapy and cardiac risk factors and will complete: * Cardiac MRI and blood tests within 1 month prior to start of radiation therapy. * Radiation therapy 1x daily for 5 days over 1 week. * End of radiation therapy visit with blood tests. * 6 month follow up visit with cardiac MRI, blood tests, questionnaires, and photographic imaging. * 12 month follow up visit with questionnaires and photographic imaging. |
| Accelerated Photon Radiation Therapy (XRT) Group | Experimental | Radiation: Accelerated Photon Radiation Therapy (XRT)Participants will be randomized 1:1 to XRT group and stratified by receipt of chemotherapy and cardiac risk factors and will complete: * Cardiac MRI and blood tests within 1 month prior to start of radiation therapy. * Radiation therapy 1x daily for 5 days over 1 week. * End of radiation therapy visit with blood tests. * 6 month follow up visit with cardiac MRI, blood tests, questionnaires, and photographic imaging. * 12 month follow up visit with questionnaires and photographic imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥18 years of age
- Non-metastatic Breast Cancer patients who are scheduled to receive conventional left-sided or bilateral breast/chest wall RT inclusive of treatment to the internal mammary lymph nodes (IMNs)
- Prior chemotherapy is permitted
- Ability to understand and the willingness to sign a written informed consent document
- No contraindication to MRI
Key exclusion criteria (4 listed)
- Person who is pregnant or breastfeeding.
- Patients receiving any other investigational agent will not be excluded from study eligibility, unless the patient is already enrolled in an interventional study evaluating cardiac toxicity. No cytotoxic therapy or radiotherapy may be used during radiation therapy.
- Contra-indication to gadolinium contrast (e.g., chronic kidney disease)
- Contra-indication to radiotherapy (e.g., scleroderma, p53 mutation)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated Proton Beam Radiation Therapy (PBT)per protocol | Radiation | Accelerated Proton Beam Radiation Therapy (PBT) Group |
| Accelerated Photon Radiation Therapy (XRT)per protocol | Radiation | Accelerated Photon Radiation Therapy (XRT) Group |
Primary outcome
Change in Myocardial Fibrosis from Baseline in Proton Beam Radiation Therapy (PBT)
Time frame: Up to 7 months (pre-treatment period to 6 month follow up)
The primary outcome is to determine whether participants who receive accelerated PBT show no increase in myocardial fibrosis on Cardiac MRI (CMR) compared to an estimated 4% increase in extracellular matrix volume fraction (ECV) in participants who receive accelerated XRT. CMR will be performed using a 3T system (Skyra, Siemens). The T1 phase on MRI will be used to measure ECV.
4 secondary outcomes
Change in Global Longitudinal Strain (GLS) on CMR from Baseline
Time frame: Up to 7 months (pre-treatment period to 6 month follow up)
Stability of Cardiac Biomarkers from Baseline
Time frame: Up to 7 months (pre-treatment period to 6 month follow up)
Body Image Evaluation
Time frame: Up to 13 months (pre-treatment period to 12 month follow up)
Change in Shoulder Function from Baseline
Time frame: Up to 13 months (pre-treatment period to 12 month follow up)
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 13 Nov 2025.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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?
A study testing Accelerated Proton Beam Radiation Therapy (PBT) and Accelerated Photon Radiation Therapy (XRT) in people with Breast Cancer and Breast Cancer Female, 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 6 inclusion and 4 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 13 Nov 2025. 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 Myocardial Fibrosis from Baseline in Proton Beam Radiation Therapy (PBT) (time frame: Up to 7 months (pre-treatment period to 6 month follow up)). 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 13 Nov 2025.