Recruiting

Phase 2

Proton TherapyPhase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer

Sponsor:

Proton Collaborative Group

Code:

NCT01766297

Conditions

Breast Cancer

Breast Neoplasm

Breast Tumor

Cancer of the Breast

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Proton Radiotherapy

Study Details

Brief 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. A clinical study is necessary to compare the results (good or bad) of proton radiation therapy.

Conditions

Breast Cancer

Breast Neoplasm

Breast Tumor

Cancer of the Breast

Study ID

NCT01766297

Start date

Feb, 2013

Status verified date

Sep, 2025

Completion date

Jan, 2035

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.
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:

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.
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.

Study Design

Enrollment

132 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Proton Radiotherapy

Proton Radiotherapy 4.0 Gy (RBE) x10 fractions to 40 Gy (RBE) Total Dose

Interventions

Proton Radiotherapy

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 ]

Central Contacts and Locations

Locations

Mayo Clinic

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Karla Shields Morales

855-776-0015 (toll free)shieldsmorales.karla@mayo.edu

Principal Investigator:

Carlos Vargas, MD

California Protons Cancer Therapy Center

Recruiting

San Diego, California, United States, 92121

Contacts

Alexandra Crawford, MPH

858-549-7431 alexandra.crawford@californiaprotons.com

Principal Investigator:

James Urbanic, MD

Northwestern Medicine Chicago Proton Center

Recruiting

Warrenville, Illinois, United States, 60555

Contacts

Don Smith, MS, CCRC

630-933-7820 donald.smith3@nm.org

Principal Investigator:

Arpi Thukral, MD

Maryland Proton Treatment Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Caitlin Eggleston

410-328-7586 caitlineggleston@umm.edu

Principal Investigator:

Elizabeth Nichols, MD

McLaren Proton Therapy Center

Recruiting

Flint, Michigan, United States, 48532

Contacts

Bradley Olsen

313-576-9730 olsenb@karmanos.org

Principal Investigator:

Brian Yeh, MD

New York Proton Center

Recruiting

New York, New York, United States, 10035

Contacts

Ryan Holder

646-968-9055 rholder@nyproton.com

Principal Investigator:

Isabelle Choi, MD

Oklahoma Proton Center

Recruiting

Oklahoma City, Oklahoma, United States, 73142

Contacts

Angela Beebe

405-773-6708 angela.beebe@okcproton.com

Principal Investigator:

John Chang, MD

Inova Schar Cancer Institute

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Sangeetha Moturi

571-472-0343 sangeetha.moturi@inova.org

Principal Investigator:

Ashish Chawla, MD

Hampton University Proton Therapy Institute

Recruiting

Hampton, Virginia, United States, 23666

Contacts

Donna Sternberg, RN, BSN, OCN

757-251-6839 donna.sternberg@hamptonproton.org

Principal Investigator:

Christopher Sinesi, MD

More Information

Sponsor

Proton Collaborative Group

Last update posted

Sep 9, 2025

Last verified

Sep, 2025

Keywords

Breast Cancer
Proton
Radiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Proton Collaborative Group on 2025-09-09.