Lumpectomy Without Radiation for Breast Cancer

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byJennifer Bellon, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This research study is a way of gaining new knowledge about whether patients can omit radiation treatment after undergoing a lumpectomy, also known as "breast conserving surgery". In this trial, we are attempting to identify which patients may not need radiation.

Research Team

Jennifer Bellon, MD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for women aged 50-75 with early-stage, favorable-risk breast cancer who've had a lumpectomy. They must be node-negative, have a life expectancy over 5 years, and can commit to endocrine therapy. Exclusions include prior systemic breast cancer treatment, other recent cancers (except certain skin/cervical), or significant comorbidities.

Inclusion Criteria

Your doctor believes you will live for more than 5 years.

I am willing to undergo hormone therapy after my main cancer treatment.

My breast cancer was removed with clear margins.

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Exclusion Criteria

I haven't had any cancer diagnosis in the past 5 years, except for non-melanoma skin cancer or cervical lesions.

Current addictive or psychiatric disorder which may preclude protocol adherence

I have not received any systemic therapy for breast cancer before joining.

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Treatment Details

Interventions

Breast-Conserving Surgery (N/A)
Prosigna (N/A)

Trial OverviewThe PRECISION Trial is testing if patients with specific types of early breast cancer can safely skip radiation after surgery. It uses the Prosigna test to identify those at low risk of recurrence who might not need further radiation treatment.

Participant Groups

2Treatment groups

Active Control

Group I: Ineligible for omission of RTActive Control1 Intervention

Prosigna confirms intermediate- or high-risk score. Participants with intermediate- or high-risk scores will be ineligible for omission of radiotherapy (RT). Some patients with low-risk scores may elect to receive RT.

Group II: Eligible for omission of RTActive Control1 Intervention

Prosigna confirms low risk score. Participant will be eligible for omission of therapy and chooses to do so. Patient will receive adjuvant endocrine therapy.