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N/A

Lumpectomy Without Radiation for Breast Cancer

Phase 2

Waitlist Available

Led By Jennifer Bellon, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

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

Must have

The primary tumor must be excised via breast conserving surgery ("lumpectomy") with negative margins ("no ink on tumor") or re-excision showing no residual disease in the re-excision specimen

Immunohistochemical studies must demonstrate the tumor to be ER+ (≥10%) or PR+, HER2- and grade 1 or 2

Must not have

At the time of enrollment, subjects may not have had any prior systemic therapy for breast cancer, including chemotherapy, hormonal therapy or targeted biologic therapy. Similarly, chemotherapy or biologic therapy must not be part of the subsequent treatment plan

Evidence of T4 disease (e.g., involvement of the chest wall, skin, dermal lymphatics, or inflammatory breast cancer)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether patients can omit radiation treatment after a lumpectomy.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Since this trial investigates omitting radiotherapy rather than adding new treatments, there are no direct side effects from interventions being tested; however, usual surgical risks and potential side effects from adjuvant endocrine therapy may occur.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer was removed with clear margins.

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My tumor is ER+ or PR+, HER2-, and not highly aggressive.

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I am between 50 and 75 years old.

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

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My tumor is 2 cm or smaller.

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I can care for myself but may not be able to do active work.

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My breast cancer diagnosis was confirmed through a biopsy.

Exclusion Criteria

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

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

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My breast cancer has spread to my chest wall or skin.

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My cancer is present only as tiny invasions in the tumor.

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My cancer is present in multiple locations within the same organ.

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My cancer is classified as grade 3.

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My cancer is present in multiple locations within the same area.

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I have cancer in both breasts.

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I have a genetic mutation linked to cancer.

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I am able to understand and give informed consent.

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I cannot or do not want to undergo hormone therapy.

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I have had radiation therapy on my chest or breast before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Five-Year Risk of Local Regional Recurrence in the Ipsilateral Breast or Lymph Nodes in Women without Adjuvant Radiotherapy

Secondary study objectives

Disease-Free Survival

Five-Year Risk of Any Recurrence: Local, Regional or Distant

Overall Survival

Awards & Highlights

No Placebo-Only Group

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

Trial Design

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.

0 / 18Eligibility criteria met