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Proton Beam Therapy

Proton Radiation for Breast Cancer

Phase 2
Waitlist Available
Research Sponsored by Proton Collaborative Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have had surgical treatment of the breast - either mastectomy or breast preserving surgery, such as lumpectomy. Re-excision of surgical margins is permitted.
Must be > = 18 years of age.
Must not have
Non-epithelial breast malignancies such as sarcoma or lymphoma.
Prior radiation to the breast or thorax.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying the long-term effects of proton therapy for locally advanced breast cancer.

Who is the study for?
This trial is for women over 18 with stage II/III breast cancer who've had surgery like a mastectomy or lumpectomy. They should expect to live at least another 10 years and agree to use non-hormonal contraception if of childbearing potential. Excluded are those with certain psychiatric, collagen diseases, pregnancy, weight over 410 pounds, large breast size unsuitable for treatment setup, prior non-breast cancers (with exceptions), unclear surgical margins without re-excision clearance, temporary breast expanders depending on assessment, previous chest radiation therapy, non-epithelial breast malignancies or a history of breast cancer.
What is being tested?
The study tests postoperative proton radiotherapy's safety and long-term effects in advanced-stage breast cancer patients. It aims to monitor acute side effects and the risk of heart-related deaths and secondary cancers after up to 15 years following treatment.
What are the potential side effects?
Potential side effects include skin reactions at the treatment site, fatigue during and after treatment sessions. Long-term risks being studied may involve heart complications or development of new cancers due to radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have undergone surgery for breast cancer, like mastectomy or lumpectomy.
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I am 18 years old or older.
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My breast cancer is confirmed by tests and is of a specific type (invasive ductal or lobular).
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My cancer is classified as stage II or III.
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Excluding my breast cancer, I am expected to live 10 more years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My breast cancer is not the common type but rather a rare form like sarcoma or lymphoma.
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I have had radiation therapy to my chest area before.
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I have a collagen vascular disease like dermatomyositis, lupus, or scleroderma.
Select...
I have had breast cancer before.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2017 Phase 2 trial • 38 Patients • NCT00495040
3%
Dermatitis
3%
Pneumonitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose-escalated Proton Therapy for Early-stage Non-small Cell l

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Proton RadiotherapyExperimental Treatment1 Intervention
Proton Radiotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton Radiotherapy
2006
Completed Phase 2
~250

Find a Location

Who is running the clinical trial?

Proton Collaborative GroupLead Sponsor
9 Previous Clinical Trials
40,914 Total Patients Enrolled
2 Trials studying Breast Cancer
408 Patients Enrolled for Breast Cancer
Eugen Hug, MDStudy ChairProton Collaborative Group

Media Library

Proton Radiotherapy (Proton Beam Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT01758445 — Phase 2
Breast Cancer Research Study Groups: Proton Radiotherapy
Breast Cancer Clinical Trial 2023: Proton Radiotherapy Highlights & Side Effects. Trial Name: NCT01758445 — Phase 2
Proton Radiotherapy (Proton Beam Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01758445 — Phase 2
~2 spots leftby Jan 2025
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