Breast CancerPhase 2NCT01766297
Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
A Phase 2 study testing Proton Radiotherapy in people with Breast Cancer and Breast Neoplasm, run by Proton Collaborative Group at 9 sites in United States.
Trial summary
The purpose of this research study is to compare the effects (good and bad) on women and their cancer using proton radiation therapy. This study is being done to see if proton radiation therapy will prove to be beneficial for women with early stage breast cancer. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Neoplasm, Breast Tumor
- What is being tested?
- Proton Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 9 sitesUnited States
- Study dates
- Feb 2013to Jan 2035
- Phase
- Phase 2
- 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 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must sign study-specific, IRB approved informed consent form prior to study entry. Note consent by legally authorized representative is not allowed for this trial.
- Must be female.
- Must be > = 50 years of age.
- Must have a life expectancy of at least 5 years based on age and co-morbidities.
- Must have pathology proven invasive ductal carcinoma (lobular is not allowed) and/or ductal carcinoma in situ (DCIS).
- One of the following criteria must be met: (a) Tumors that are microscopically multifocal must be 3.0 cm or less in total aggregate size and encompassed within a single scar (b) Patient does not have microscopically multifocal tumor.
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- For tumors that are invasive, if in the presence of extensive intraductal component (EIC), the entire pathologic tumor size (including both the intraductal and invasive component) must be 3.0 cm or less.
- Must be Stage 0, I, II (Tis, T1, or T2, N0, M0 per AJCC criteria 7th and/or 8th Ed.). If stage II, the tumor size must be < = 3.0 cm. A patient with invasive histology must have nodal stage pN0 by H\&E stains on sentinel node biopsy or axillary lymph node dissection.
- Must have ER positive disease with ER/PR report available.
- For tumors that are invasive, HER2 must be performed (positive or negative is acceptable).
- Must have a lumpectomy performed, with documented negative surgical margins by 0.2 cm or more. If re-excision results in negative surgical margins 0.2 cm or more, patient is eligible.
- If image guidance with daily cone beam CT with direct physician visual assessment is used for treatment positioning, the presence of markers or clips in the surgical bed is recommended but not required. If cone beam CT imaging will NOT be used for image guidance, then the patient must be prepared to have 2 fiducial markers minimum, 3 preferred, placed prior to treatment (if not previously done).
- If markers or clips were placed at the time of surgery, patient must be able to start treatment within 12 weeks after lumpectomy or re-excision for adequate margins.
- If markers were not placed at the time of surgery and are needed, patient must have markers placed within 6 weeks after surgery.
- If systemic chemotherapy was given, patient must have had clips or markers placed at the time of surgery (if they are needed) and patient must have simulation scans within 6 weeks of the completion of the chemotherapy.
- Must be able to start treatment within 12 weeks of surgery or 8 weeks of finalization of chemotherapy.
Who cannot join
- Previous history of ipsilateral invasive breast cancer or DCIS.
- Any clinical or radiographically suspicious nodes, unless biopsy proven benign.
- Non-epithelial malignancies such as sarcoma or lymphoma.
- Suspicious residual microcalcifications on mammography of either breast, unless negative for malignancy on pathology.
- Multicentric or bilateral disease unless biopsy of the clinical abnormalities are performed and result is negative.
- Lymphovascular space invasion (LVSI) on pathology specimen.
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- Any previously treated breast carcinoma or synchronous breast carcinoma in ipsilateral breast.
- Prior radiation therapy to the ipsilateral breast or thorax.
- Paget's disease of the nipple.
- Histologic examination showing invasive lobular histology.
- Skin involvement.
- Breasts technically unsatisfactory for radiation treatment upon the discretion of the treating physician.
- Significant infection or other co-existing medical condition that would preclude protocol therapy such as pregnancy, HIV/AIDS or collagen vascular diseases specifically systemic lupus erythematosus, scleroderma, or dermatomyositis.
- Known BRCA 1 or BRCA 2 mutation.
- Pregnant or lactating.
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
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
McLaren Proton Therapy Center
Flint, Michigan, 48532
Bradley Olsen, 313-576-9730, olsenb@karmanos.org
Brian Yeh, MD
- Recruiting
Hampton University Proton Therapy Institute
Hampton, Virginia, 23666
Donna Sternberg, RN, BSN, OCN, 757-251-6839, donna.sternberg@hamptonproton.org
Christopher Sinesi, 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
Oklahoma Proton Center
Oklahoma City, Oklahoma, 73142
Angela Beebe, 405-773-6708, angela.beebe@okcproton.com
John Chang, MD
- Recruiting
California Protons Cancer Therapy Center
San Diego, California, 92121
Alexandra Crawford, MPH, 858-549-7431, alexandra.crawford@californiaprotons.com
James Urbanic, MD
- Recruiting
Mayo Clinic
Scottsdale, Arizona, 85259
Karla Shields Morales, 855-776-0015 (toll free), shieldsmorales.karla@mayo.edu
Carlos Vargas, MD
- Recruiting
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, 60555
Don Smith, MS, CCRC, 630-933-7820, donald.smith3@nm.org
Arpi Thukral, MD
About this study
The purpose of this research study is to compare the effects (good and bad) on women and their cancer using proton radiation therapy.
This study is being done to see if proton radiation therapy will prove to be beneficial for women with early stage breast cancer. A clinical study is necessary to compare the results (good or bad) of proton radiation therapy.
Read the detailed description
Current standard of care for early stage breast cancer is mastectomy or breast conserving therapy with whole breast irradiation following lumpectomy. However, studies of breast cancer recurrence have demonstrated the majority of tumors to recur in or adjacent to the original tumor site. The question has thus been raised as to whether radiation to the whole breast is necessary or justified. Limiting radiation to the area of the original tumor may reduce acute and long-term skin and organ toxicities while making radiation therapy more convenient and less expensive. Several clinical trials are underway comparing partial breast irradiation (PBI) to whole breast irradiation. Numerous centers are offering partial breast irradiation outside of clinical trials as well, despite the lack of long-term safety and efficacy data on PBI.
Available PBI methods include brachytherapy, in which catheters or balloons are surgically inserted to deliver radiation therapy to the lumpectomy cavity, and conventional external beam radiation therapy, or EBRT. External beam photon therapy is attractive for its non-invasive nature and ability to deliver a more homogenous dose distribution compared to brachytherapy, however it also delivers a greater radiation dose to surrounding normal breast tissue.Proton therapy has the capacity to provide the same advantages as photon EBRT while minimizing dose to normal surrounding tissue. Clinical data on PBI with protons is minimal, however, leaving many questions unanswered. The impetus behind this protocol is to address these gaps by further investigating the feasibility, safety, and efficacy of proton therapy for partial breast irradiation.
- Conditions
- Breast Cancer, Breast Neoplasm, Breast Tumor, Cancer of the Breast
- Being tested
- Proton Radiotherapy
- Keywords
- Breast Cancer, 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 RadiotherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Proton Radiotherapy | Experimental | Proton Radiotherapy 4.0 Gy (RBE) x10 fractions to 40 Gy (RBE) Total Dose Receives: Radiation: Proton Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess events of freedom from ipsilateral breast recurrence occurrences in patients receiving partial breast proton radiation therapy limited to the region of the tumor.
Freedom from failure (FFF): The events for FFF will be the first ipsilateral breast cancer recurrence. It is expected that less than 3% of patients will experience an ipsilateral breast cancer recurrence (FFF ≥ 97%). A recurrence rate of ≥ 10% (FFF ≤ 90%) is considered unacceptable. Therefore, the null hypothesis is the FFF of ipsilateral breast cancer recurrence is 90% or lower and the alternative hypothesis is that FFF of ipsilateral breast cancer is 97% or higher.
Measured: At 3 years
Secondary outcomes (5)
Assess number and severity of acute and long-term toxicity of partial breast irradiation using proton therapy for the treatment of early stage breast cancer.
Measured: On average every 6 months for life
To assess relationship between breast size and partial breast dosimetry.
Measured: Average every 6 months for 3 years
Determine quality of life results.
Measured: Average every 6 months for 3 years
To determine overall survival rate of patients with breast cancer treated with proton radiation.
Measured: At 3 years
To determine recurrence pattern of patients with breast cancer treated with proton partial breast irradiation.
Measured: At 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionJan 2027 (estimated)
- Study completionJan 2035 (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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Proton Collaborative Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Andrew Chang, MD, Study chair, Proton Collaborative Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01766297
- Sponsor's protocol ID
- BRE007-12
- Status last verified
- Sep 2026
- First submitted
- 28 Dec 2012
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
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 II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT01766297
- Acronym / sponsor ID
- BRE007-12
- Conditions
- Breast Cancer, Breast Neoplasm, Breast Tumor, Cancer of the Breast
- Keywords
- Breast Cancer, Proton, Radiation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- Proton Collaborative GroupResearch network
- Study start
- Feb 2013
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2035 (estimated)
- First posted
- 11 Jan 2013 (estimated)
- 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 compare the effects (good and bad) on women and their cancer using proton radiation therapy.
This study is being done to see if proton radiation therapy will prove to be beneficial for women with early stage breast cancer. A clinical study is necessary to compare the results (good or bad) of proton radiation therapy.
Detailed description
Current standard of care for early stage breast cancer is mastectomy or breast conserving therapy with whole breast irradiation following lumpectomy. However, studies of breast cancer recurrence have demonstrated the majority of tumors to recur in or adjacent to the original tumor site. The question has thus been raised as to whether radiation to the whole breast is necessary or justified. Limiting radiation to the area of the original tumor may reduce acute and long-term skin and organ toxicities while making radiation therapy more convenient and less expensive. Several clinical trials are underway comparing partial breast irradiation (PBI) to whole breast irradiation. Numerous centers are offering partial breast irradiation outside of clinical trials as well, despite the lack of long-term safety and efficacy data on PBI.
Available PBI methods include brachytherapy, in which catheters or balloons are surgically inserted to deliver radiation therapy to the lumpectomy cavity, and conventional external beam radiation therapy, or EBRT. External beam photon therapy is attractive for its non-invasive nature and ability to deliver a more homogenous dose distribution compared to brachytherapy, however it also delivers a greater radiation dose to surrounding normal breast tissue.Proton therapy has the capacity to provide the same advantages as photon EBRT while minimizing dose to normal surrounding tissue. Clinical data on PBI with protons is minimal, however, leaving many questions unanswered. The impetus behind this protocol is to address these gaps by further investigating the feasibility, safety, and efficacy of proton therapy for partial breast irradiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton Radiotherapy | Experimental | Radiation: Proton RadiotherapyProton Radiotherapy 4.0 Gy (RBE) x10 fractions to 40 Gy (RBE) Total Dose |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Must sign study-specific, IRB approved informed consent form prior to study entry. Note consent by legally authorized representative is not allowed for this trial.
- Must be female.
- Must be > = 50 years of age.
- Must have a life expectancy of at least 5 years based on age and co-morbidities.
- Must have pathology proven invasive ductal carcinoma (lobular is not allowed) and/or ductal carcinoma in situ (DCIS).
Key exclusion criteria (15 listed)
- Previous history of ipsilateral invasive breast cancer or DCIS.
- Any clinical or radiographically suspicious nodes, unless biopsy proven benign.
- Non-epithelial malignancies such as sarcoma or lymphoma.
- Suspicious residual microcalcifications on mammography of either breast, unless negative for malignancy on pathology.
- Multicentric or bilateral disease unless biopsy of the clinical abnormalities are performed and result is negative.
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 Radiotherapy | Radiation | Proton Radiotherapy |
Primary outcome
To assess events of freedom from ipsilateral breast recurrence occurrences in patients receiving partial breast proton radiation therapy limited to the region of the tumor.
Time frame: At 3 years
Freedom from failure (FFF): The events for FFF will be the first ipsilateral breast cancer recurrence. It is expected that less than 3% of patients will experience an ipsilateral breast cancer recurrence (FFF ≥ 97%). A recurrence rate of ≥ 10% (FFF ≤ 90%) is considered unacceptable. Therefore, the null hypothesis is the FFF of ipsilateral breast cancer recurrence is 90% or lower and the alternative hypothesis is that FFF of ipsilateral breast cancer is 97% or higher.
5 secondary outcomes
Assess number and severity of acute and long-term toxicity of partial breast irradiation using proton therapy for the treatment of early stage breast cancer.
Time frame: On average every 6 months for life
To assess relationship between breast size and partial breast dosimetry.
Time frame: Average every 6 months for 3 years
Determine quality of life results.
Time frame: Average every 6 months for 3 years
To determine overall survival rate of patients with breast cancer treated with proton radiation.
Time frame: At 3 years
To determine recurrence pattern of patients with breast cancer treated with proton partial breast irradiation.
Time frame: At 3 years
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.
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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.
California Protons Cancer Therapy Center
San Diego, United States
Northwestern Medicine Chicago Proton Center
Warrenville, United States
Andrew Chang, 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 2 study testing Proton Radiotherapy in people with Breast Cancer and Breast Neoplasm, 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 16 inclusion and 15 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 assess events of freedom from ipsilateral breast recurrence occurrences in patients receiving partial breast proton radiation therapy limited to the region of the tumor. (time frame: At 3 years). 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.