AzTrials
AzTrials

Breast Cancer RadiationPhase 2NCT02653755

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

A Phase 2 study testing Prosigna in people with Breast Cancer Radiation, run by Dana-Farber Cancer Institute at 6 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 75 years, women only
Conditions the study is for
Breast Cancer Radiation
What is being tested?
Prosigna
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
671 participants
Where
6 sitesUnited States
Study dates
15 Dec 2015to 15 May 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed invasive breast cancer
  • 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.
  • The tumor must be ≤2 cm (T1) in the largest dimension.
  • Immunohistochemical studies must demonstrate the tumor to be ER+ (≥10%) or PR+, HER2- and grade 1 or 2.
  • The patient must have undergone either sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND) demonstrating pathologic node-negativity (pN0). However, patients with immunohistochemical evidence of isolated tumor cells in a lymph node [pN0(i+)] are eligible if no deposit >0.2mm is identified.
  • Age: this study is open to patients between 50 and 75 years of age (inclusive). Patients younger than 50 years of age are excluded based on prior data suggesting a different natural history for breast cancers arising in premenopausal women (with different subtype and biologic distributions that may confound the current aims). Women older than 75 years of age are excluded from this protocol due to historical difficulties achieving robust follow-up in this population, along with competing comorbidities which have been shown to interfere with subsequent breast cancer monitoring and evaluation.
Show all 9Show fewer
  • ECOG performance status ≤2 (Karnofsky ≥60%)
  • Life expectancy of >5 years per the clinical impression of the treating physician(s).
  • Eligible for and willing to undergo a course of adjuvant endocrine therapy.

Who cannot join

  • 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.
  • Clinical, radiographic or pathologic evidence of multicentric disease.
  • Evidence of T4 disease (e.g., involvement of the chest wall, skin, dermal lymphatics, or inflammatory breast cancer).
  • Grade 3 histology.
  • Tumors in which the invasive component is present only as micro-invasion.
  • Multicentric invasive or in site carcinoma
Show all 15Show fewer
  • Bilateral breast malignancy.
  • Inability or unwillingness to tolerate endocrine therapy.
  • Documented mutation of TP53, BRCA1, BRCA2, or other hereditary cancer syndromes.
  • Significant comorbidity associated with an estimation of <5 remaining life years.
  • Another diagnosis of malignancy within the 5 years preceding enrollment (excluding non-melanoma skin cancers or in situ cervical lesions, which are permitted).
  • Inability to understand or provide informed consent.
  • Current addictive or psychiatric disorder which may preclude protocol adherence.
  • Prior breast or chest radiotherapy for any indication.
  • Pregnant or lactating.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • Johns Hopkins

    Baltimore, Maryland, 21287

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115

  • NYU Langone Health

    New York, New York, 10016

  • Memorial Sloane Kettering Cancer Center

    New York, New York, 10065

  • Lifespan Cancer Institute

    Providence, Rhode Island, 02903

Other trials in United States

About this study

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.

Read the detailed description

This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational treatment to learn whether it is appropriate for treating a specific disease.

The purpose of this study is to determine whether certain patients between the ages of 50 and 75 can safely omit radiation treatment after having a lumpectomy.In this research study, the investigators are using standard laboratory tests along with the Prosigna test to see if certain patients can avoid radiation, without having a higher risk of the cancer coming back in the future.

A portion of the participant surgical specimen will be prospectively maintained for future study using institutionally-approved tissue banking procedures.

The FDA (the U.S. Food and Drug Administration) has cleared the Prosigna test for generating a risk category and numerical score to assess the risk of distant recurrence, and has cleared us to investigate the use of the Prosigna test for helping with decisions about radiation.

Being tested
Prosigna
Keywords
Breast Cancer Radiation, Radiotherapy for Favorable-Risk Breast cancer, Radiotherapy Omission

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ProsignaDevice

    Also called PAM-50

    Transcriptional profile of 50 genes used for risk stratification.

Study groups in NCT02653755
Study groupRoleWhat they receive
Ineligible for omission of RTActive comparatorProsigna 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.
Receives: Device: Prosigna
Eligible for omission of RTActive comparatorProsigna confirms low risk score. Participant will be eligible for omission of therapy and chooses to do so. Patient will receive adjuvant endocrine therapy.
Receives: Device: Prosigna

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Using information gathered from follow-up physical examinations and mammography, the 5-year risk of local regional recurrence in women who omit radiotherapy post-lumpectomy will be evaluated.

    Measured: 5 years

Secondary outcomes (3)

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

    Using information gathered from follow-up physical examinations and mammography, the 5-year risk of any recurrence in women who omit radiotherapy post-lumpectomy will be evaluated.

    Measured: 5 years

  2. Overall Survival

    Using information gathered from follow-up appointments and other record sources, 5-year survival rates will be evaluated.

    Measured: 5 years

  3. Disease-Free Survival

    Using information gathered from follow-up physical exams, mammography and other imaging as necessary, the rate of disease-free status at 5 years will be evaluated.

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jan 2016 (estimated)
  2. Study start15 Dec 2015
  3. Primary completion15 May 2030 (estimated)
  4. Study completion15 May 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
A Phase II Study of Breast-Conserving Surgery without Adjuvant Radiotherapy for Favorable-Risk Breast Cancer
Masking
None (open label)
Enrolment
671 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02653755
Sponsor's protocol ID
15-255
Status last verified
Jun 2026
First submitted
10 Jan 2016
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Ho AY, Bellon JR. Overcoming Resistance - Omission of Radiotherapy for Low-Risk Breast Cancer. N Engl J Med. 2023 Feb 16;388(7):652-653. doi: 10.1056/NEJMe2216133. No abstract available.

    PubMed 36791166

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Prosigna in people with Breast Cancer Radiation, run by Dana-Farber Cancer Institute at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Five-Year Risk of Local Regional Recurrence in the Ipsilateral Breast or Lymph Nodes in Women without Adjuvant Radiotherapy (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02653755, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in