Proton Therapy for Breast Cancer Treatment Duration

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

Recruiting Phase 3 Interventional Study
Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.

At a Glance
Age
19 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
276 (estimated)
Sponsor
Proton Collaborative Group · Research network
Who this trial is looking for

This trial is looking for women with breast cancer who need radiation therapy. Participants will receive either a shorter treatment course of 3 weeks or a standard course of 5 weeks using a specific type of radiation called proton therapy.

Are You a Good Fit for This Trial?
Rules you out PregnancyInflammatory breast cancerDistant metastatic diseaseActive skin rashHistory of connective tissue disorder

You may be able to join if

  • I have Stage I-III breast cancer.
  • I have had breast conserving surgery or mastectomy.
  • I need postoperative radiation therapy to my breast or chest wall.
  • I have been recommended to receive treatment to my regional lymph nodes.
  • I have a negative pregnancy test if I can become pregnant.
  • I can start radiation treatment within 12 weeks of my last surgery or chemotherapy.
  • I can participate even if I have breast implants or other breast reconstruction.
  • I have a complete medical evaluation done within the last 90 days.

You may not be able to join if

  • I have skin ulceration or inflammatory breast cancer.
  • I have detectable residual disease unless it’s a small lymph node.
  • I have had prior radiation therapy to the same area.
  • I have had surgery to remove breast implants due to infection.
  • I have evidence of distant metastatic disease.
  • I am currently pregnant or breastfeeding.
  • I have a condition that would prevent me from receiving treatment.
  • I have a history of certain connective tissue disorders.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

The purpose of this research study is to learn more about the effects of using proton radiation therapy delivered over a shorter course of treatment (3 weeks) compared with a longer, standard course of treatment (5 weeks) for women with breast cancer who require radiotherapy to the breast/chest wall and regional lymph nodes.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: * 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) * Histologicall…
Contacts

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