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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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 lymph nodes are cancer-free or only have tiny cancer cells not larger than 0.2mm.
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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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Five-Year Risk of Local Regional Recurrence in the Ipsilateral Breast or Lymph Nodes in Women without Adjuvant Radiotherapy
Secondary outcome measures
Disease-Free Survival
Five-Year Risk of Any Recurrence: Local, Regional or Distant
Overall Survival

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.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,200 Total Patients Enrolled
NanoString Technologies, Inc.Industry Sponsor
10 Previous Clinical Trials
1,439 Total Patients Enrolled
Jennifer Bellon, MDPrincipal InvestigatorDana-Farber Cancer Institute

Media Library

Breast-Conserving Surgery (N/A) Clinical Trial Eligibility Overview. Trial Name: NCT02653755 — Phase 2
Breast Cancer Therapy Research Study Groups: Ineligible for omission of RT, Eligible for omission of RT
Breast Cancer Therapy Clinical Trial 2023: Breast-Conserving Surgery Highlights & Side Effects. Trial Name: NCT02653755 — Phase 2
Breast-Conserving Surgery (N/A) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02653755 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned omitting radiotherapy in certain scenarios?

"Our assessment of the safety of Ineligible for omission of RT was 2, due to having some evidence supporting its security but yet no proof that it is efficacious."

Answered by AI

Is this experiment open to elderly individuals?

"In order to qualify for the study, prospective participants must fall within a particular age range; 50 years old being the lower limit and 75 years old representing the upper bound."

Answered by AI

Are more participants being accepted for this study presently?

"Evidently, this medical trial is not presently enrolling patients. It was initially advertised on the 5th of May 2016 and last modified on October 27th 2022. Nonetheless, there are 2287 other trials actively searching for participants at the moment."

Answered by AI

To whom is participation in this clinical study accessible?

"This medical research is recruiting 672 female patients between the age of 50 and 75 who have breast cancer radiation. The eligibility criteria are as follows: ECOG performance status ≤2 (Karnofsky ≥60%), life expectancy >5 years according to treating physicians, willing to undertake a course of adjuvant endocrine therapy, tumor size ≤2 cm (T1), removal via lumpectomy with negative margins or re-excision showing no residual disease in specimen, and finally an age range from 50 to 75 inclusive. Women younger than 50 and older than 75 cannot participate due to different subtypes for premenopausal women which may"

Answered by AI

What is the geographical reach of this research endeavor?

"This clinical trial is being conducted in 6 different locations; some of which include NYU Langone Health situated in New york, Lifespan Cancer Institute located in Providence and Massachusetts General Hospital positioned in Boston."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
The PRECISION Trial (Profiling Early Breast Cancer for Radiotherapy Omission): A Phase II Study of Breast-Conserving Surgery Without Adjuvant Radiotherapy for Favorable-Risk Breast Cancer
Jennifer Bellon, MD 2016. "The PRECISION Trial (Profiling Early Breast Cancer for Radiotherapy Omission): A Phase II Study of Breast-Conserving Surgery Without Adjuvant Radiotherapy for Favorable-Risk Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02653755.
~111 spots leftby Dec 2025
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