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One-Time radiation boost during breast surgery shows promise in Early-Stage cancer trial

NCT ID NCT02927912

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a single dose of radiation directly to the tumor site during breast-conserving surgery (lumpectomy) and before reconstruction is safe and effective for women with early-stage breast cancer. About 108 participants with stage I-II breast cancer will receive this targeted radiation boost. The goal is to kill remaining tumor cells while potentially improving cosmetic results and reducing the need for additional treatments.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

108 people

The number who actually took part.

Started

Oct 2017

Expected to finish

Nov 2026

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

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: * Pathologically proven diagnosis of breast cancer * Clinical node negative stage I (T1N0) or stage II (T2N0) breast cancer * Preoperative ultrasound of the axilla with biopsy of suspicious nodes is recommended as clinically indicated per the discretion of the treating physician * Appropriate stage for protocol entry including no clinical evidence for distant metastases based upon the following minimum diagnostic workup * History/physical examination, documentation of weight and Zubrod performance status 0-2 within 28 days prior to study entry * Right and left mammography within 90 days of diagnostic biopsy establishing diagnosis * Absolute neutrophil count \> 1800 cells/cubic mm * Platelets \>= 75,000 cells/cubic mm * Hemoglobin \>= 8 g/dL * Women of childbearing potential must have a negative urine or serum pregnancy test within 14 days of study entry * Women of childbearing potential must be non-pregnant and non-lactating and willing to use medically acceptable form of contraception during radiation therapy * Patients must provide study specific informed consent prior to study entry Exclusion Criteria: * Clinical T4, N2 or N3, M1 pathologic stages III or IV breast cancer * Prior invasive non-breast malignancy (except non-melanoma skin cancer, carcinoma in situ of the cervix) unless disease free for a minimum of 3 yrs prior to study entry * Prior invasive or in-situ carcinoma of the breast (prior lobular breast carcinoma in situ \[LCIS\] is eligible) * Two or more cancers not resectable through a single lumpectomy incision * Bilateral breast cancer * Ductal breast carcinoma in situ (DCIS) only * Non-epithelial breast malignancies such as sarcoma/lymphoma * Male breast cancer * Paget's disease of the nipple * Prior radiotherapy to the breast or prior radiation to the region of the ipsilateral breast that would result in overlap of radiation fields * Pregnancy or women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception * Active systemic lupus, erythematosus, or any history of scleroderma, dermatomyositis with active rash * Medical, psychiatric or other condition that would prevent the patient from receiving the protocol therapy or providing informed consent

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105, United States

  • Centre Hospitalier de I'Universite de Montreal

    Québec, Montreal, H2X0C1, Canada

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • University Hospitals

    Cleveland, Ohio, 44106, United States

  • University of North Carolina

    Chapel Hill, North Carolina, 27599, United States

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