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Single dose of radiation during lumpectomy may control early breast cancer

NCT ID NCT01570998

Disease control Sponsor: University of California, San Francisco 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests giving a single dose of radiation directly to the tumor site during breast-conserving surgery for early-stage breast cancer. The goal is to see if this one-time treatment works as well as standard radiation therapy that requires multiple visits. Over 1,200 participants are being followed for up to 5 years to check for cancer return, side effects, and survival.

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

1,259 people

The number who actually took part.

Started

May 2012

Expected to finish

Dec 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

45 years and older

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: * Suitable for breast conserving surgery * T1 and T2 (\< 3.5 cm), N0, M0 Exclusion Criteria: * Axillary lymph node positive breast cancer * Tumor size \> 3.5 cm * Extensive intraductal component (EIC \>= 25% of the lumpectomy specimen involved with ductal carcinoma in situ), as assessed on surgical pathologic lumpectomy specimen * Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound; magnetic resonance imaging (MRI) or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy * Inability to assess pathologic margin status * Synchronous bilateral breast cancer at the time of diagnosis * Ipsilateral breast had a previous cancer and/or prior in-field radiation * Patients known to have BRCA1/2 gene mutations (testing for gene mutations is not required) * Patients undergoing primary systemic treatment (hormones or chemotherapy) as initial treatment with neoadjuvant reducing tumor size * Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years or greater * Any factor included as exclusion criteria in the participating center's treatment policy statement * Additional exclusion criteria for University of California San Francisco (UCSF) (as laid out in the Treatment Policy): * Patients under the age of 50 * Estrogen receptor negative (as defined in Treatment Policy under "Pathology") * Human epidermal growth factor receptor 2 (HER2) positive (as defined in Treatment Policy under "HER2") * Lymphovascular invasion * High grade * Tumors \> 3 cm * Node positive patients * Prior chemotherapy or hormone therapy

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Stage IA breast cancer Stage IIA breast cancer

Contacts and locations

Locations

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704, United States

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311, United States

  • Cleveland Clinic

    Fort Lauderdale, Florida, 33308, United States

  • Columbia University/Herbert Irving Cancer Center

    New York, New York, 10032, United States

  • Community Cancer Center South

    Indianapolis, Indiana, 46227, United States

  • Community Hospital at Dobbs Ferry

    Dobbs Ferry, New York, 10522, United States

  • Cornell University

    Ithaca, New York, 14850-2488, United States

  • Dignity Health - California Hospital Medical Center

    Los Angeles, California, 90015, United States

  • Greenwich Hospital

    Greenwich, Connecticut, 06830, United States

  • Holy Cross Hospital

    Fort Lauderdale, Florida, 33308, United States

  • Inova Fairfax Hospital Cancer Center

    Fairfax, Virginia, 22031, United States

  • John Muir Medical Center-Walnut Creek

    Walnut Creek, California, 94598, United States

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Marie Yeager Cancer Center, Spectrum Health Lakeland

    Saint Joseph, Michigan, 49085, United States

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007, United States

  • MedStar Washington Hospital Center

    Washington D.C., District of Columbia, 20010, United States

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404, United States

  • Mercy Medical Center

    Baltimore, Maryland, 21202, United States

  • Northwestern University

    Chicago, Illinois, 60611, United States

  • Saint Luke's Hospital-Anderson Campus

    Easton, Pennsylvania, 18045, United States

  • Sentara Port Warwick

    Newport News, Virginia, 23606, United States

  • University of California, Irvine

    Irvine, California, 92617, United States

  • University of California, San Francisco

    San Francisco, California, 94143, United States

  • Vassar Brothers Medical Center

    Poughkeepsie, New York, 12601, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.