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Proton Therapy for Breast Cancer: Shorter vs. Standard Treatment

This study is looking at two ways to give proton therapy (a type of radiation treatment) for breast cancer. It compares a shorter treatment plan (3 weeks) with a standard plan (5 weeks) for women who need radiation to their breast or chest wall and nearby lymph nodes. The main goal is to see if the shorter treatment causes similar rates of skin and soft tissue side effects as the standard treatment. You might be able to join if you are a woman, 19 years or older, with Stage I-III breast cancer who needs radiation after surgery. The study is currently unclear about its recruitment status.

Study design
This is an interventional study planning to enroll 276 women. It compares two different ways of delivering proton therapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 2 years after radiation therapy to check for side effects.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05856773

Conventionally Fractionated vs. Hypofractionated Comprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning Proton Therapy

Recruiting
PHASE3Ages 19+InterventionalTreatment
Proton Collaborative Group
~276 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:Proton Therapy

At a glance

Recruiting sites
9 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over 2 years after radiation therapy

Conditions

Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

9 sites across 7 states
Florida3
Arizona1
California1
Georgia1
Maryland1
New York1
Virginia1

Study leadership

  • Isabelle Choi, MD · STUDY_CHAIR · Proton Collaborative Group

Who to contact

June Leonard
[email protected]
855-776-0015 (toll free)
Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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, 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
Documentation of negative metastatic workup by whole body Positron Emission Tomography - Computed Tomography (PET/CT) or by combined CT of the chest, abdomen, pelvis and Bone scan
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
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

Exclusion

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
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 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.

What this trial measures

  • 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 radiotherapy2 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.