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Proton Beam Therapy
Proton Therapy for Breast Cancer (COMPRO Trial)
Phase 3
Recruiting
Research Sponsored by Proton Collaborative Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years after radiation therapy
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Summary
This trial aims to understand the impact of a shorter course of treatment (3 weeks) using proton radiation therapy, compared to the standard longer course of treatment (5 weeks), for women with breast cancer who
Who is the study for?
This trial is for women with Stage I-III breast cancer who've had surgery or need postoperative radiation to the breast/chest and lymph nodes. They must have no distant metastases, be in good physical condition (ECOG 0-2), not pregnant, and able to start treatment within 12 weeks of surgery/chemo. Breast reconstruction and bilateral cancer are okay if at least one side gets full nodal irradiation.
What is being tested?
The study compares two ways of delivering proton radiation therapy: a shorter course over 3 weeks versus a standard longer course over 5 weeks. It aims to understand the effects on women needing radiotherapy after breast cancer surgery.
What are the potential side effects?
Proton therapy may cause skin redness, soreness, fatigue, swelling in treated areas, and changes in skin texture. Rarely it can lead to heart or lung issues due to its proximity during treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer diagnosis is confirmed and requires radiation therapy including to the chest and lymph nodes.
Select...
My scans show no signs of cancer spread.
Select...
I can care for myself and am up and about more than 50% of my waking hours.
Select...
I had surgery for Stage I-III breast cancer and need radiation therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years after radiation therapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years after radiation therapy
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Secondary study objectives
To assess patient-reported quality of life
To assess physician-reported cosmetic outcomes
Side effects data
From 2022 Phase 1 & 2 trial • 40 Patients • NCT0183983861%
Skin hyperpigmentation
29%
Telangiectasia
29%
Localized edema
11%
Superficial soft tissue fibrosis
7%
Pruritus
7%
Erythema
7%
Dermatitis radiation
7%
Fatigue
7%
Fibrosis of breast
7%
Dry skin
4%
Respiratory failure
4%
Enterocolitis infectious
4%
Reproductive system and breast disorders - Other, specify
4%
Intracranial hemorrhage
4%
Non-cardiac chest pain
4%
Sepsis
4%
Small intestine ulcer
4%
Breast pain
4%
Breast pigment change
4%
Generalized muscle weakness
4%
Chest pain
4%
Syncope
4%
Breast edema
4%
burning sensation of skin
4%
Breast tenderness
4%
Skin hypopigmentation
4%
Fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
APBI With Protons Phase 2
APBI With Protons Phase 1
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm B - HypofractionationExperimental Treatment1 Intervention
40.05 Gy (RBE) in 15 daily fractions of 2.67 Gy (RBE) plus a Tumor Bed Boost (for intact breast) of 10 Gy (RBE) in 4-5 daily fractions of 2-2.5 Gy (RBE)
\*\*Additional boost of 10-20 Gy (RBE) in 2-2.5 Gy (RBE) fractions to clinically involved lymph nodes or chest wall/scar allowed at the treating physician's discretion\*\*
Group II: Arm A - Standard FractionationActive Control1 Intervention
50-50.4 Gy (RBE) in 25-28 daily fractions of 1.8-2.0 Gy (RBE) plus a Tumor Bed Boost (for intact breast) of 10 Gy (RBE) in 4-5 daily fractions of 2-2.5 Gy (RBE)
\*\*Additional boost of 10-20 Gy (RBE) in 2-2.5 Gy (RBE) fractions to clinically involved lymph nodes or chest wall/scar allowed at the treating physician's discretion\*\*
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Proton Therapy
2013
Completed Phase 2
~320
Find a Location
Who is running the clinical trial?
Proton Collaborative GroupLead Sponsor
9 Previous Clinical Trials
40,858 Total Patients Enrolled
2 Trials studying Breast Cancer
352 Patients Enrolled for Breast Cancer
Isabelle Choi, MDStudy ChairProton Collaborative Group