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Radiation Therapy

Short-Course Radiation Therapy for Breast Cancer (PRESERVE Trial)

N/A
Recruiting
Led By Danielle Rodin, MD
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinically node negative
Age > 18 years
Must not have
Serious non-malignant disease (cardiovascular, pulmonary, systemic lupus erythematosus, scleroderma), which would preclude radiation treatment
Multifocal or multicentric disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 year, 3 years, and 5 years post rpbi
Awards & highlights
No Placebo-Only Group

Summary

This trial looks at whether women with early-stage breast cancer can safely get a shorter radiation treatment plan (1 week) with fewer treatments than usual.

Who is the study for?
This trial is for women over 18 with early-stage breast cancer who've had prior radiation and surgery, are clinically node negative, have a tumor under 3.0 cm without distant metastases or severe late skin toxicity from previous treatments. It excludes those with multifocal disease, implants or pacemakers near the chest, recent chemotherapy, certain psychiatric disorders, specific non-malignant diseases, or current pregnancy.
What is being tested?
The PRESERVE trial tests a shorter course of re-irradiation called rPBI (26 Gray in 5 daily fractions over one week) after breast-conserving surgery to see if it's safe and effective as an alternative to mastectomy for women who previously received whole breast radiation.
What are the potential side effects?
Potential side effects may include skin reactions similar to sunburns (redness, peeling), fatigue during treatment weeks, mild discomfort in the treated area. Long-term effects can be changes in breast size and shape but are expected to be less due to reduced radiation volume.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has not spread to my lymph nodes.
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I am older than 18 years.
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My breast cancer recurrence is in one spot only.
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My surgical wound has fully healed without any infection.
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My tumor is smaller than 3.0 cm in size.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have serious heart, lung, lupus, or scleroderma diseases that would prevent radiation treatment.
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My cancer is present in multiple locations.
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My cancer has spread to lymph nodes or other parts of my body.
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I have severe skin side effects from past radiation, as per CTCAE v5.0.
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My cancer has spread to nearby tissues.
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My breast cancer has a significant area of non-invasive growth.
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My breast cancer is of the infiltrating lobular type.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 year, 3 years, and 5 years post rpbi
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 year, 3 years, and 5 years post rpbi for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Grade ≥3 toxicity associated with treatment
Secondary study objectives
Financial toxicity associated with treatment
Frequency radiation-associated toxicity (acute)
Radiation Sickness
+12 more

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: rPBIExperimental Treatment1 Intervention
26Gy in 5 daily fractions over 1-week

Find a Location

Who is running the clinical trial?

CHU de Quebec (Université Laval)UNKNOWN
l'Hopital Maisonneuve-RosemontUNKNOWN
L'Institut de recherche du Centre universitaire de sante McGillUNKNOWN

Media Library

rPBI (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05592938 — N/A
Breast Cancer Research Study Groups: rPBI
Breast Cancer Clinical Trial 2023: rPBI Highlights & Side Effects. Trial Name: NCT05592938 — N/A
rPBI (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05592938 — N/A
~110 spots leftby Jun 2027
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