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Proton Beam Therapy

Arm B - Hypofractionation 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

COMPRO 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.Check my eligibility

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.See study design

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.

COMPRO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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.

COMPRO Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years after radiation therapy for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome 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 radiotherapy

Secondary outcome measures

To assess patient-reported quality of life

To assess physician-reported cosmetic outcomes

To determine breast cancer-specific survival

+5 more

Other outcome measures

To correlate dosimetric parameters with acute and late adverse events for the development of model dose constraints for comprehensive nodal irradiation for breast cancer using a moderately hypofractionated regimen with PBS-PT

Side effects data

From 2020 Phase 2 trial • 275 Patients • NCT00915005

73%

Fatigue

71%

Radiation Induced Dermatitis

52%

Esophatitis

49%

Cough

45%

Dyspnea

38%

Dysphagia

33%

Odynophagia

30%

Anorexia

24%

Pneumonitis

12%

Pleural effusion

Dehydration

Pneumonia

Pulmonary fibrosis

Fever

Pericardial effusion

Gastro Stricutre

Cardiac Ischemia / Infarction

Hypoxia

100%

80%

60%

40%

20%

Study treatment Arm

Intensity-modulated (Photon) Radiotherapy (IMRT)

Passive Scattering Proton Therapy (PSPT)

COMPRO 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

2009

Completed Phase 2

~280

0 / 4Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for patient participation in this clinical trial?

"Based on the information provided by clinicaltrials.gov, this specific clinical trial is not currently seeking participants. The trial was initially posted on February 1st, 2024 and was last updated on January 29th, 2024. However, it's important to note that there are presently a total of 2608 other trials actively recruiting individuals for participation."

Answered by AI

Has the hypofractionation treatment plan known as Arm B received official approval from the FDA?

"Based on the classification of this trial as a Phase 3 study, which indicates the presence of data supporting both efficacy and safety from multiple rounds of research, our team at Power rates the safety level for Arm B - Hypofractionation as 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Conventionally Fractionated vs. Hypofractionated Comprehensive Nodal Irradiation for Breast Cancer Using Pencil Beam Scanning Proton Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05856773.