SBRT for Early Stage Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byRachel Blitzblau, MD PhD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Duke University

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This protocol seeks to build on the favorable results of the investigators' phase I trial (Pro00015617) by extending the findings to a larger cohort of subjects.In this study, the investigators hypothesize that 21Gy (Gray) as a single fraction can be delivered preoperatively to a larger group of subjects (n100). The primary objective is to determine physician reported rates of good/excellent cosmesis at baseline and 6 months, 1, 2, and 3 years post-treatment as measured by the NRG cosmesis scale

Research Team

Rachel Blitzblau, MD PhD

Principal Investigator

Duke Health

Eligibility Criteria

This trial is for women aged 60+ or those 50-59 with a low Oncotype score, diagnosed with early-stage breast cancer (ER+, HER2-) that's less than or equal to 2cm. They must have normal blood counts, be candidates for breast preservation, and agree to use contraception if of child-bearing potential. It excludes HER2 positive patients, those who've had neoadjuvant chemotherapy, pregnant women, and anyone unable to undergo the treatment due to medical conditions.

Inclusion Criteria

My cancer is estrogen receptor positive and HER2 negative.

Women of child-bearing potential must consent to use adequate contraception

Tissue samples from other hospitals will be checked again to confirm the diagnosis.

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Exclusion Criteria

My cancer is HER2 positive.

I did not have a clip placed during my biopsy and I do not want one now.

Your treatment plan cannot be followed.

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Treatment Details

Interventions

SBRT (Radiation Therapy)

Trial OverviewThe study tests preoperative single-fraction radiotherapy delivering 21Gy in one session for early-stage breast cancer patients. The goal is to assess cosmetic outcomes using the NRG cosmesis scale at various intervals post-treatment up to three years.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Single arm 21Gy stereotactic radiotherapyExperimental Treatment1 Intervention

Subjects will receive a single fraction of 21Gy of stereotactic radiotherapy before proceeding to surgery.

SBRT is already approved in Canada, Japan for the following indications: