Breast CancerPhase 3COMPRONCT05856773
Conventionally Fractionated vs. Hypofractionated Comprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning Proton Therapy
A Phase 3 study testing Proton Therapy in people with Breast Cancer, run by Proton Collaborative Group at 9 sites in United States.
Trial summary
The purpose of this research study is to learn more about the effects of using proton radiation therapy delivered over a shorter course of treatment (3 weeks) compared with a longer, standard course of treatment (5 weeks) for women with breast cancer who require radiotherapy to the breast/chest wall and regional lymph… Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Proton Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 9 sitesUnited States
- Study dates
- 21 Mar 2024to Feb 2041
- Phase
- Phase 3
- 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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with Stage I-III breast cancer who have undergone breast conserving surgery or mastectomy and have been recommended to receive postoperative radiation therapy to the breast or chest wall and regional draining lymph nodes (axilla levels I-III, SCV, IMN)
- Histologically documented breast cancer (invasive mammary, ductal, medullary, tubular, metaplastic, mucinous, lobular, or ductal carcinoma in situ) for which treatment with radiation therapy to the breast/chest wall and comprehensive regional lymph nodes including the internal mammary chain is recommended
- No clinical evidence or suspicion of distant metastatic disease
- History and physical exam within 90 days prior to study registration
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- Negative pregnancy test for women of child-bearing potential
Show all 9Show fewer
- Able to begin radiation treatment within 12 weeks of last surgery or last day of chemotherapy
- Presence of breast implants, breast expanders, tissue flap, or other breast reconstruction are allowed
- Bilateral breast cancer is allowed if at least one side will be treated with comprehensive nodal irradiation per protocol treatment and will be recorded as the laterality receiving comprehensive nodal irradiation. If both sides will be treated comprehensively, it will be documented as such
Who cannot join
- Presence of skin ulceration and / or ipsilateral satellite nodules and/or edema (including peau d'orange) (T4b or T4c disease) or diagnosis of inflammatory breast cancer (T4d disease)
- Residual gross disease detected by imaging or clinical exam with the exception of <2cm internal mammary lymph node or supraclavicular lymph node amenable to sequential boost
- Prior history of radiation therapy overlapping with current target volume (including intraoperative brachytherapy, interstitial catheter brachytherapy, balloon brachytherapy, external beam radiation therapy)
- Prior history of explant surgery or implant removal due to infection or wound healing issues without subsequent implant or flap reconstruction
- Presence of double/dual port tissue expander
- Clinical or radiographic evidence of distant metastatic disease
Show all 13Show fewer
- Pregnant or breast-feeding females
- Non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
- History of connective tissue disorder (i.e., systemic lupus erythematosus, scleroderma), dermatomyositis, xeroderma pigmentosum
- Known BRCA 1 or BRCA 2 mutation
- Presence of an active skin rash
- Prior history of breast cancer
- Prior invasive non-study malignancy unless disease free for ≥ 3 years. Non-melanoma skin cancer, well-differentiated thyroid cancers, in situ carcinomas of the oral cavity, cervix, and other organs, and tumors that are not thought to impact the life expectancy of the patient are permissible.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
Emory Proton Therapy Center
Atlanta, Georgia, 30308
Leann Schilling, MPH, CCRP, 404-686-0286, leann.schilling@emory.edu
Sunil Dutta, MD
- Recruiting
Maryland Proton Treatment Center
Baltimore, Maryland, 21201
Caitlin Eggleston, 410-328-7586, caitlineggleston@umm.edu
Elizabeth Nichols, MD
- Recruiting
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Sangeetha Moturi, 571-472-0343, sangeetha.moturi@inova.org
Ashish Chawla, MD
- Recruiting
University of Florida Proton Therapy Institute
Jacksonville, Florida, 32206
Robin Cacchio, 904-588-1460, rcacchio@floridaproton.org
Julie Bradley, MD
- Recruiting
Dwoskin Proton Therapy Center
Miami, Florida, 33125
Zuzel Rodriguez, 305-243-0124, z.rodriguez1@med.miami.edu
Cristiane Takita, MD
- Recruiting
Miami Cancer Institute
Miami, Florida, 33176
Alex Kudryashev, 786-596-2000, alexku@baptisthealth.net
Joseph Panoff, MD
- Recruiting
New York Proton Center
New York, New York, 10035
Ryan Holder, 646-968-9055 ext. 387, rholder@nyproton.com
Isabelle Choi, MD
- Recruiting
California Protons Cancer Therapy Center
San Diego, California, 92121
Alexandra Crawford, MPH, 858-549-7431, alexandra.crawford@californiaprotons.com
Iain MacEwan, MD
- Recruiting
Mayo Clinic
Scottsdale, Arizona, 85259
June Leonard, 855-776-0015 (toll free), leonard.june@mayo.edu
Carlos Vargas, MD
About this study
Official title: Phase III Randomized Trial of Conventionally Fractionated vs. Hypofractionated COMprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning PROton Therapy (COMPRO)
The purpose of this research study is to learn more about the effects of using proton radiation therapy delivered over a shorter course of treatment (3 weeks) compared with a longer, standard course of treatment (5 weeks) for women with breast cancer who require radiotherapy to the breast/chest wall and regional lymph nodes.
Read the detailed description
This study is being done to see if comprehensive regional nodal radiation therapy to the breast or chest wall and regional lymph node area using proton therapy delivered with a hypofractionated approach (less treatment days) will result in rates of treatment related skin and soft tissue side effects that are non-inferior compared to conventionally fractionated proton radiotherapy regimens.
- Conditions
- Breast Cancer
- Being tested
- Proton Therapy
- Keywords
- Proton Radiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton TherapyRadiation
Pencil Beam Scanning (PBS)
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Standard Fractionation | Active comparator | 50-50.4 Gy (RBE) in 25-28 daily fractions of 1.8-2.0 Gy (RBE) plus a Tumor Bed Boost (for intact breast) of 10 Gy (RBE) in 4-5 daily fractions of 2-2.5 Gy (RBE)
Additional boost of 10-20 Gy (RBE) in 2-2.5 Gy (RBE) fractions to clinically involved lymph nodes or chest wall/scar allowed at the treating physician's discretion Receives: Radiation: Proton Therapy |
| Arm B - Hypofractionation | Other | 40.05 Gy (RBE) in 15 daily fractions of 2.67 Gy (RBE) plus a Tumor Bed Boost (for intact breast) of 10 Gy (RBE) in 4-5 daily fractions of 2-2.5 Gy (RBE)
Additional boost of 10-20 Gy (RBE) in 2-2.5 Gy (RBE) fractions to clinically involved lymph nodes or chest wall/scar allowed at the treating physician's discretion Receives: Radiation: Proton Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if the rate of grade ≥3 treatment-related skin and soft tissue toxicities with comprehensive nodal irradiation for breast cancer using hypofractionated PBS proton therapy is non-inferior to conventionally-fractionated proton radiotherapy
This study will investigate if adjuvant comprehensive regional nodal radiotherapy to the breast or chest wall and regional lymph nodes including the axilla (levels I-III), supraclavicular (SCV), and internal mammary (IMN) lymph nodes using pencil beam scanning proton therapy delivered with a hypofractionated regimen results in rates of acute and late grade 3 or worse treatment-related skin and soft tissue toxicities that are non-inferior compared with rates in pencil beam scanning proton therapy using conventionally fractionated regimens.
Measured: 2 years after radiation therapy
Secondary outcomes (9)
To determine the rate of any grade ≥3 treatment-related adverse events
Measured: 2, 5, and 10 years after radiation therapy
To determine local recurrence rates
Measured: 2, 5, and 10 years after radiation therapy
To determine regional recurrence rates
Measured: 2, 5, and 10 years after radiation therapy
To determine distant recurrence rates
Measured: 2, 5, and 10 years after radiation therapy
To determine breast cancer-specific survival
Measured: 2, 5, and 10 years after radiation therapy
To determine overall survival
Measured: 2, 5, and 10 years after radiation therapy
To assess patient-reported quality of life
FACT-B questionnaire
Measured: 2, 5, and 10 years after radiation therapy
To assess patient-reported quality of life
BREAST-Q questionnaire
Measured: 2, 5, and 10 years after radiation therapy
To assess physician-reported cosmetic outcomes
Physician reported cosmesis form
Measured: 2, 5, and 10 years after radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study start21 Mar 2024
- Primary completionFeb 2038 (estimated)
- Study completionFeb 2041 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 276 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proton Collaborative Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Isabelle Choi, MD, Study chair, Proton Collaborative Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05856773
- Sponsor's protocol ID
- BRE009-23
- Acronym
- COMPRO
- Status last verified
- Sep 2026
- First submitted
- 1 Apr 2023
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Randomized Trial of Conventionally Fractionated vs. Hypofractionated COMprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning PROton Therapy (COMPRO)
- ClinicalTrials.gov ID
- NCT05856773
- Acronym / sponsor ID
- COMPRO / BRE009-23
- Conditions
- Breast Cancer
- Keywords
- Proton Radiation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 276 participants (estimated)
- Lead sponsor
- Proton Collaborative GroupResearch network
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- Feb 2038 (estimated)
- Study completion
- Feb 2041 (estimated)
- First posted
- 12 May 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.
The purpose of this research study is to learn more about the effects of using proton radiation therapy delivered over a shorter course of treatment (3 weeks) compared with a longer, standard course of treatment (5 weeks) for women with breast cancer who require radiotherapy to the breast/chest wall and regional lymph nodes.
Detailed description
This study is being done to see if comprehensive regional nodal radiation therapy to the breast or chest wall and regional lymph node area using proton therapy delivered with a hypofractionated approach (less treatment days) will result in rates of treatment related skin and soft tissue side effects that are non-inferior compared to conventionally fractionated proton radiotherapy regimens.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A - Standard Fractionation | Active comparator | Radiation: Proton Therapy50-50.4 Gy (RBE) in 25-28 daily fractions of 1.8-2.0 Gy (RBE) plus a Tumor Bed Boost (for intact breast) of 10 Gy (RBE) in 4-5 daily fractions of 2-2.5 Gy (RBE) Additional boost of 10-20 Gy (RBE) in 2-2.5 Gy (RBE) fractions to clinically involved lymph nodes or chest wall/scar allowed at the treating physician's discretion |
| Arm B - Hypofractionation | Other | Radiation: Proton Therapy40.05 Gy (RBE) in 15 daily fractions of 2.67 Gy (RBE) plus a Tumor Bed Boost (for intact breast) of 10 Gy (RBE) in 4-5 daily fractions of 2-2.5 Gy (RBE) Additional boost of 10-20 Gy (RBE) in 2-2.5 Gy (RBE) fractions to clinically involved lymph nodes or chest wall/scar allowed at the treating physician's discretion |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with Stage I-III breast cancer who have undergone breast conserving surgery or mastectomy and have been recommended to receive postoperative radiation therapy to the breast or chest wall and regional draining lymph nodes (axilla levels I-III, SCV, IMN)
- Histologically documented breast cancer (invasive mammary, ductal, medullary, tubular, metaplastic, mucinous, lobular, or ductal carcinoma in situ) for which treatment with radiation therapy to the breast/chest wall and comprehensive regional lymph nodes including the internal mammary chain is recommended
- No clinical evidence or suspicion of distant metastatic disease
- History and physical exam within 90 days prior to study registration
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
Key exclusion criteria (13 listed)
- Presence of skin ulceration and / or ipsilateral satellite nodules and/or edema (including peau d'orange) (T4b or T4c disease) or diagnosis of inflammatory breast cancer (T4d disease)
- Residual gross disease detected by imaging or clinical exam with the exception of <2cm internal mammary lymph node or supraclavicular lymph node amenable to sequential boost
- Prior history of radiation therapy overlapping with current target volume (including intraoperative brachytherapy, interstitial catheter brachytherapy, balloon brachytherapy, external beam radiation therapy)
- Prior history of explant surgery or implant removal due to infection or wound healing issues without subsequent implant or flap reconstruction
- Presence of double/dual port tissue expander
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 |
|---|---|---|
| Proton TherapyPencil Beam Scanning (PBS) | Radiation | Arm A - Standard Fractionation, Arm B - Hypofractionation |
Primary outcome
To determine if the rate of grade ≥3 treatment-related skin and soft tissue toxicities with comprehensive nodal irradiation for breast cancer using hypofractionated PBS proton therapy is non-inferior to conventionally-fractionated proton radiotherapy
Time frame: 2 years after radiation therapy
This study will investigate if adjuvant comprehensive regional nodal radiotherapy to the breast or chest wall and regional lymph nodes including the axilla (levels I-III), supraclavicular (SCV), and internal mammary (IMN) lymph nodes using pencil beam scanning proton therapy delivered with a hypofractionated regimen results in rates of acute and late grade 3 or worse treatment-related skin and soft tissue toxicities that are non-inferior compared with rates in pencil beam scanning proton therapy using conventionally fractionated regimens.
9 secondary outcomes
To determine the rate of any grade ≥3 treatment-related adverse events
Time frame: 2, 5, and 10 years after radiation therapy
To determine local recurrence rates
Time frame: 2, 5, and 10 years after radiation therapy
To determine regional recurrence rates
Time frame: 2, 5, and 10 years after radiation therapy
To determine distant recurrence rates
Time frame: 2, 5, and 10 years after radiation therapy
To determine breast cancer-specific survival
Time frame: 2, 5, and 10 years after radiation therapy
To determine overall survival
Time frame: 2, 5, and 10 years after radiation therapy
To assess patient-reported quality of life
Time frame: 2, 5, and 10 years after radiation therapy
To assess patient-reported quality of life
Time frame: 2, 5, and 10 years after radiation therapy
To assess physician-reported cosmetic outcomes
Time frame: 2, 5, and 10 years after radiation therapy
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 29 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
California Protons Cancer Therapy Center
San Diego, United States
University of Florida Proton Therapy Institute
Jacksonville, United States
Isabelle Choi, MD study chair
Proton Collaborative Group
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Proton Therapy in people with Breast Cancer, run by Proton Collaborative Group at 9 sites 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 9 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 29 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 9 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine if the rate of grade ≥3 treatment-related skin and soft tissue toxicities with comprehensive nodal irradiation for breast cancer using hypofractionated PBS proton therapy is non-inferior to conventionally-fractionated proton radiotherapy (time frame: 2 years after radiation therapy). 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 29 Sep 2026.