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134 Participants NeededMy employer runs this trial

Partial Breast Irradiation for Breast Cancer

(SASHA Trial)

MI
Overseen ByMassey IIT Research Operations
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: Virginia Commonwealth University
Must be taking: Aromatase inhibitors
Disqualifiers: Pregnant, Breastfeeding, Collagen-vascular disease, Paget's disease, Prior breast cancer, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This phase 2, single arm prospective study has been designed to determine the safety of delivering accelerated partial breast irradiation (APBI) with a multicatheter interstitial implant in a single fraction over 1 day. This is a method of delivering radiation therapy directly into or close to a tumor.

Who Is on the Research Team?

BQ

Bridget Quinn, MD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for women aged 40-85 with a new diagnosis of certain early-stage breast cancers (DCIS or small invasive tumors) who have had surgery to remove the tumor. Participants must not be pregnant, breastfeeding, or have had prior breast radiation. Some specific cancer types and medical conditions are excluded.

Inclusion Criteria

I am female.
I understand the study and am willing to sign the consent form.
I have been newly diagnosed with DCIS or invasive breast cancer.
See 9 more

Exclusion Criteria

Pregnant or breastfeeding
Medical, psychological, or social condition increasing risk or limiting adherence per investigator opinion
My surgical margins are positive or could not be checked under a microscope.
See 8 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive accelerated partial breast irradiation (APBI) with a multicatheter interstitial implant in a single fraction over 1 day

1 day

Follow-up

Participants are monitored for safety, effectiveness, and cosmetic outcomes after treatment

5 years
Baseline, 5 weeks, 6 months, annually up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Partial Breast Irradiation

Trial Overview

The study tests if it's safe to give partial breast radiation in one treatment using thin tubes placed near the tumor site after surgery. All participants receive this single-session internal radiation therapy.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Partial Breast IrradiationExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials
732
Recruited
22,900,000+

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