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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up during accrual period, up to 2 years

Awards & highlights

PRESERVE Trial 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.Check my eligibility

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.See study design

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.

PRESERVE Trial 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.

PRESERVE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ during accrual period, up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~during accrual period, up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and during accrual period, up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of participants accrued to the trial

Secondary outcome measures

Frequency radiation-associated toxicity (acute)

Radiation Sickness

Invasive breast cancer free survival

+10 more

PRESERVE Trial Design

1Treatment groups

Experimental Treatment

Group I: rPBIExperimental Treatment1 Intervention

26Gy in 5 daily fractions over 1-week

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthOTHER

1,369 Previous Clinical Trials

840,583 Total Patients Enrolled

37 Trials studying Breast Cancer

7,252 Patients Enrolled for Breast Cancer

Centre hospitalier de l'Université de Montréal (CHUM)OTHER

366 Previous Clinical Trials

129,622 Total Patients Enrolled

4 Trials studying Breast Cancer

613 Patients Enrolled for Breast Cancer

Peter MacCallum Cancer Centre, AustraliaOTHER

95 Previous Clinical Trials

25,492 Total Patients Enrolled

4 Trials studying Breast Cancer

571 Patients Enrolled for Breast Cancer

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

Frequently Asked Questions

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

Are there still vacancies available for those seeking to participate in this clinical trial?

"Using information from clinicaltrials.gov, it is evident that this research study has recently been modified and is currently recruiting participants. The initial posting date was June 27th 2023."

Answered by AI

To which demographic does the eligibility criteria for this experiment extend?

"To be eligible for selection to this investigation, potential participants must have a diagnosis of breast cancer and fall within the age range of 18-99. Only 15 individuals will be admitted in total."

Answered by AI

To what extent is this research protocol being utilized by volunteers?

"Yes, the data from clinicaltrials.gov shows that this trial is actively recruiting participants. It was first posted on June 27th 2023 and subsequently updated the same day; 15 individuals are needed to be recruited at 1 medical centre."

Answered by AI