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Radiation-Free option for Low-Risk breast cancer?

NCT ID NCT02400190

Knowledge-focused Sponsor: University of Michigan Rogel Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 202 postmenopausal women with early-stage, hormone-sensitive breast cancer who choose to skip radiation after lumpectomy and take only hormone therapy. Researchers track cancer recurrence over 10 years to see if this approach is safe for this low-risk group. The goal is to gather evidence that might spare future patients from unnecessary radiation.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
endocrine therapy alone without radiotherapy
What this could lead to
If successful, this could show that carefully selected patients can avoid radiation and its side effects without increasing cancer recurrence risk.
What could go wrong
This is an observational study, not a treatment trial. It only tracks outcomes in a very specific, low-risk group, so results may not apply to most breast cancer patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

202 people

The number who actually took part.

Started

May 2015

Expected to finish

May 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 69 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Postmenopausal status, as defined by (a) patients age 60 or greater, or, (b) patients age 50-69 with either (a) s/p bilateral oophorectomy, or, (b) intact uterus without menses in the past 12 months, or, (c) biochemical confirmation of postmenopausal status. * Histopathological confirmation of Stage 1 (pT1N0M0) invasive breast cancer status post breast conserving surgery * Negative axillary nodes (isolated tumor cells with no cluster measuring \>0.2mm allowed) * Allowable options for axillary staging include: * Sentinel node biopsy only * Sentinel node biopsy followed by axillary dissection * Axillary dissection only * Margins of excision ≥2mm * ER+, PR+, Her2 - using the current College of American Pathologists guidelines * Oncotype-DX RS ≤ 18 * Disease must be unifocal on clinical, radiologic, and pathologic examination * Registration within 90 days of last surgical procedure for breast cancer treatment * Patient must willingly sign study specific informed consent prior to study entry * Patient must be a candidate for and willing to take endocrine therapy for minimum of 5 years (aromatase inhibitor or tamoxifen). Patients who have already begun endocrine therapy after lumpectomy are eligible. * Patient must have had breast imaging (mammogram or MRI) of the ipsilateral breast within 6 months and contralateral breast within 1 year of study entry. * Patient must have Zubrod performance status 0-2 Exclusion Criteria: * Evidence of multifocal or multicentric breast cancer that has not been biopsy-proven negative. Note that MRI is not required for this study, but if performed, evidence of disease beyond the site of the primary tumor in the ipsilateral breast or in the contralateral breast must be biopsy-proven not to be malignant before registration. * Metastatic disease. Note that no specific staging studies are mandated, but any studies performed must not provide clear evidence of metastatic spread. * Previous radiation therapy to the breast region * Prior DCIS or invasive breast cancer * Bilateral breast cancer * Prior non-breast invasive malignancy other than non-melanoma skin cancer, unless there has been no evidence of disease for at least 5 years * Known carrier of a mutation known to predispose towards breast cancer development (including BRCA-1 and BRCA-2). Note: testing for mutation status is not required for this protocol; this criterion applies only to patients who have been tested and have known carrier status.

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Conditions

The condition(s) this trial relates to.

breast neoplasm invasive breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast neoplasms

Contacts and locations

Locations

  • East Carolina University

    Greenville, North Carolina, 27853, United States

  • Harvard University

    Cambridge, Massachusetts, 02138, United States

  • Johns Hopkins University

    Baltimore, Maryland, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Northwell Health

    Lake Success, New York, 11042, United States

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901, United States

  • Stanford University

    Stanford, California, 94305, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

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