Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 50 Years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests the good and bad effects of proton radiation aimed at part of the breast. It is for women age 50 or older with early-stage breast cancer who have had surgery to remove the tumor.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Must be a woman age 50 or older and sign the study consent form yourself.
- Must be expected to live at least 5 years, based on age and other health conditions.
- Must have cancer that starts in the breast ducts: invasive ductal cancer, which has spread outside the ducts, or DCIS, which stays inside them.
- Must have stage 0, I, or II cancer that has not spread to lymph nodes or distant body parts. Stage II tumors must be 3 cm or smaller. Invasive cancer needs lymph node testing.
- Cancer must be ER-positive, meaning estrogen helps it grow. An ER/PR hormone test report is needed. Invasive cancer also needs a HER2 test; either result is allowed.
- If there are several tiny tumor spots, their total size must be 3 cm or less and they must fit within one surgery scar. Invasive cancer with a large area of cancer inside the ducts must also total 3 cm or less.
- Must have had a lumpectomy, surgery to remove the tumor, with at least 0.2 cm of cancer-free tissue at the edges. A second surgery to clear the edges is allowed.
- Must meet scan and marker rules for aiming radiation. Must start treatment within 12 weeks of surgery or 8 weeks after chemotherapy ends. Extra timing rules apply for markers and planning scans.
Who can't join
- Past breast cancer or another breast cancer at the same time in the breast being treated, or past radiation to that breast or chest.
- Lymph nodes that look suspicious, or tiny calcium spots left on a mammogram of either breast that look suspicious, unless tissue tests show no cancer.
- Cancer in separate areas of the breast or in both breasts, unless tissue tests of the abnormal areas show no cancer.
- Cancer in the breast’s milk-making glands, sarcoma, lymphoma, Paget’s disease of the nipple, or cancer involving the skin.
- Cancer cells found in small blood vessels or lymph vessels, which carry fluid through the body.
- Breasts that the treating doctor finds unsuitable for radiation treatment.
- A serious infection or another condition that prevents study treatment, such as HIV/AIDS, lupus, scleroderma, or dermatomyositis. Pregnancy or breastfeeding also rules out joining.
- A known BRCA1 or BRCA2 gene change.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (9)
AZ
- Mayo Clinic · Scottsdale, AZ 85259Karla Shields Morales · Study contact · 855-776-0015 (toll free) · shieldsmorales.karla@mayo.eduCarlos Vargas, MD · Principal investigatorMore trials in Scottsdale
CA
- California Protons Cancer Therapy Center · San Diego, CA 92121Alexandra Crawford, MPH · Study contact · 858-549-7431 · alexandra.crawford@californiaprotons.comJames Urbanic, MD · Principal investigatorMore trials in San Diego
IL
- Northwestern Medicine Chicago Proton Center · Warrenville, IL 60555Don Smith, MS, CCRC · Study contact · 630-933-7820 · donald.smith3@nm.orgArpi Thukral, MD · Principal investigatorMore trials in Warrenville
MD
- Maryland Proton Treatment Center · Baltimore, MD 21201Caitlin Eggleston · Study contact · 410-328-7586 · caitlineggleston@umm.eduElizabeth Nichols, MD · Principal investigatorMore trials in Baltimore
MI
- McLaren Proton Therapy Center · Flint, MI 48532Bradley Olsen · Study contact · 313-576-9730 · olsenb@karmanos.orgBrian Yeh, MD · Principal investigatorMore trials in Flint
NY
- New York Proton Center · New York, NY 10035Ryan Holder · Study contact · 646-968-9055 ext. 387 · rholder@nyproton.comIsabelle Choi, MD · Principal investigatorMore trials in New York
OK
- Oklahoma Proton Center · Oklahoma City, OK 73142Angela Beebe · Study contact · 405-773-6708 · angela.beebe@okcproton.comJohn Chang, MD · Principal investigatorMore trials in Oklahoma City
VA
- Inova Schar Cancer Institute · Fairfax, VA 22031Sangeetha Moturi · Study contact · 571-472-0343 · sangeetha.moturi@inova.orgAshish Chawla, MD · Principal investigatorMore trials in Fairfax
- Hampton University Proton Therapy Institute · Hampton, VA 23666Donna Sternberg, RN, BSN, OCN · Study contact · 757-251-6839 · donna.sternberg@hamptonproton.orgChristopher Sinesi, MD · Principal investigatorMore trials in Hampton