Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
NCT ID: NCT01766297
Last Updated: 2025-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE2
132 participants
INTERVENTIONAL
2013-02-28
2035-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Differential Impact of Proton Beam Irradiation Versus Conventional Radiation on Organs-at-risk in Stage II-III Breast Cancer Patients
NCT03270072
Partial Breast Proton Therapy for Early Stage Breast Cancer
NCT01310530
Partial-Breast Radiation Therapy in Treating Women With Early-Stage Breast Cancer
NCT01008514
Partial Breast Irradiation (PBI) for Selected Patients With Early Invasive or Non-Invasive Breast Cancer
NCT00694577
Preoperative Single-Fraction Radiotherapy in Early Stage Breast Cancer
NCT02482376
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Proton Radiotherapy
Proton Radiotherapy 4.0 Gy (RBE) x10 fractions to 40 Gy (RBE) Total Dose
Proton Radiotherapy
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Proton Radiotherapy
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
* 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.
Exclusion Criteria
* 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.
* 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.
50 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Proton Collaborative Group
NETWORK
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrew Chang, MD
Role: STUDY_CHAIR
Proton Collaborative Group
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mayo Clinic
Scottsdale, Arizona, United States
California Protons Cancer Therapy Center
San Diego, California, United States
Northwestern Medicine Chicago Proton Center
Warrenville, Illinois, United States
Maryland Proton Treatment Center
Baltimore, Maryland, United States
McLaren Proton Therapy Center
Flint, Michigan, United States
New York Proton Center
New York, New York, United States
Oklahoma Proton Center
Oklahoma City, Oklahoma, United States
Inova Schar Cancer Institute
Fairfax, Virginia, United States
Hampton University Proton Therapy Institute
Hampton, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BRE007-12
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.