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Hypofractionated Radiotherapy for Breast Cancer

Phase 2

Waitlist Available

Led By Carlos E. Vargas, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years

Histological confirmation of breast cancer

Must not have

Medical contraindication to receipt of radiotherapy

Active systemic lupus or scleroderma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 2 years after treatment initiation

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effectiveness of giving a specific type of radiation therapy, called hypofractionated radiotherapy, either before or after breast surgery for patients with non-metastatic breast cancer

Who is the study for?

This trial is for individuals with non-metastatic breast cancer, meaning their cancer hasn't spread from the original site. It's exploring if giving radiation in larger doses over a shorter period before or after breast surgery can be effective and safe.

What is being tested?

The study is testing hypofractionated radiotherapy, which involves fewer but larger doses of radiation, either before (preoperative) or after (postoperative) breast surgery. The goal is to see if this approach reduces treatment time and side effects while being an effective treatment for various types of breast cancer.

What are the potential side effects?

Potential side effects may include skin irritation, fatigue, changes in breast size or shape, pain or discomfort at the treatment site. However, preoperative therapy might reduce these due to better oxygenation and unchanged blood supply.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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My breast cancer diagnosis was confirmed through tissue examination.

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My cancer is at a stage where it has not spread to distant parts of my body.

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I can take care of myself and am up and about more than half of my waking hours.

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I am recommended to undergo radiotherapy for breast cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot receive radiotherapy due to health reasons.

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I have active systemic lupus or scleroderma.

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I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

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I am not willing to use birth control.

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I have previously received radiation therapy on the same side breast or chest wall.

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My breast cancer has come back.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 2 years after treatment initiation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 2 years after treatment initiation

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 2 years after treatment initiation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of grade 3 or higher radiation treatment (RT) related adverse events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (Surgery + postoperative radiation therapy)Experimental Treatment12 Interventions

Patients undergo SOC chemotherapy and SOC breast surgery followed by breast hypofractionated radiotherapy QD for a total of 5 fractions. Patients also undergo CT, MRI, PET, CEDM, and/or breast US throughout the study. Additionally, patients undergo a breast biopsy and may undergo optional blood sample collection and tissue collection on study.

Group II: Arm I (Preoperative radiation therapy + surgery)Experimental Treatment12 Interventions

Patients undergo SOC chemotherapy followed by breast hypofractionated radiotherapy QD for a total of 5 fractions. Patients then undergo SOC breast surgery 10 weeks after radiation treatment. Patients also undergo CT, MRI, PET, CEDM, and/or breast US throughout the study. Additionally, patients undergo a breast biopsy and may undergo optional blood sample collection and tissue collection on study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Contrast Enhanced Digital Mammography

2019

N/A

~570

Breast Surgery

2021

Completed Phase 2

~60