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Radiation before breast surgery may improve results

NCT ID NCT04871516

Disease control Sponsor: Rutgers, The State University of New Jersey 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether giving an extra dose of radiation (a boost) before breast cancer surgery is safe and helpful. About 103 people with early-stage breast cancer that hasn't spread will receive the boost, then standard radiation and surgery. The goal is to see if this approach reduces side effects and leads to better cosmetic outcomes and tumor control.

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

103 people

The number who actually took part.

Started

May 2021

Expected to finish

Jan 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

18 years and older

Sex

Anyone

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: * Breast cancer patients with biopsy proven invasive cancer * Clinically and radiographically node negative * No indication of metastatic disease * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Synchronous bilateral invasive cancer allowed * Negative serum pregnancy test within one month from the radiation therapy (RT) boost delivery * Willingness to participate in the clinical trial and adhere to the study protocol * Individuals of all races, genders and ethnic groups are eligible for this trial Exclusion Criteria: * Need for neoadjuvant chemotherapy * Inflammatory breast cancer (cT4) * Multicentric tumor * Prior ipsilateral breast or thoracic RT * Contraindication for baseline magnetic resonance imaging (MRI) * Contraindication for surgery * Distant metastatic disease * Other synchronous cancer (besides bilateral breast) * Contraindication to radiation therapy (presence of scleroderma or other collagen vascular disease) * Any serious or uncontrolled medical disorder that, in the opinion of the investigator, may increase the risk associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or interfere with the interpretation of study results

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma in situ invasive breast carcinoma

As listed by the trial registrant

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

Anatomic stage 0 breast cancer ajcc V8 Anatomic stage I breast cancer ajcc V8 Anatomic stage IA breast cancer ajcc V8 Anatomic stage IB breast cancer ajcc V8 Anatomic stage II breast cancer ajcc V8 Anatomic stage IIA breast cancer ajcc V8 Anatomic stage IIB breast cancer ajcc V8 Invasive breast carcinoma Non-metastatic breast carcinoma Prognostic stage 0 breast cancer ajcc V8 Prognostic stage I breast cancer ajcc V8 Prognostic stage IA breast cancer ajcc V8 Prognostic stage IB breast cancer ajcc V8 Prognostic stage II breast cancer ajcc V8 Prognostic stage IIA breast cancer ajcc V8 Prognostic stage IIB breast cancer ajcc V8 Prognostic stage III breast cancer ajcc V8 Prognostic stage IIIA breast cancer ajcc V8 Prognostic stage IIIB breast cancer ajcc V8 Prognostic stage IIIC breast cancer ajcc V8

Contacts and locations

Locations

  • Clara Maass Medical Center

    Belleville, New Jersey, 07109, United States

  • Cooperman Barnabas Medical Center (Saint Barnabas Medical Center)

    Livingston, New Jersey, 07039, United States

  • RWJBarnabas Health - Community Medical Center

    Toms River, New Jersey, 08755, United States

  • RWJBarnabas Health - Monmouth Medical Center Southern Campus

    Lakewood, New Jersey, 08701, United States

  • RWJBarnabas Health - Newark Beth Israel Medical Center

    Newark, New Jersey, 07112, United States

  • RWJBarnabas Health Jersey City Medical Center

    Jersey City, New Jersey, 07302, United States

  • RWJBarnabas Health-Trinitas Hospital and Comprehensive Care

    Elizabeth, New Jersey, 07202, United States

  • Robert Wood Johnson University Hospital Somerset

    Somerville, New Jersey, 08876, United States

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903, United States

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07101, United States

  • The Cancer Institute of New Jersey Hamilton

    Hamilton, New Jersey, 08690, United States

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