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Heat zap after lumpectomy may cut breast cancer return and second surgeries

NCT ID NCT01153035

Disease control Sponsor: University of Arkansas 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 applying radiofrequency ablation (a heat treatment) to the area where a breast tumor was removed can kill any leftover cancer cells and reduce the need for a second surgery. It involves 104 women aged 50 and older with early-stage breast cancer. The goal is to see if this extra step lowers the chance of cancer coming back near the surgery site over 5 years.

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

104 people

The number who actually took part.

Start date

Jun 2010

Expected to finish

Jun 2027

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 100 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: * Patient is a female, ≥ 50 years of age * The tumor size is ≤ 3 cm (on pre-study radiologic OR clinical exam) * The tumor is unicentric and unilateral * The tumor is not involving the skin * Pathology confirms ductal in situ (DCIS) OR infiltrating ductal carcinoma (IDC), grade I-III * If tumor is IDC, pathology must be hormone receptor positive (ER+ and/or PR+) * Patient signs current written informed consent and HIPAA forms Exclusion Criteria: * Patient is under 50 years of age * Patient is male * Tumor \> 3 cm in diameter * Bilateral malignancy * Clinically positive lymph nodes * Tumor involving the skin * Pathology confirms invasive lobular carcinoma * Breast implants * Less than 2 years disease-free survival from previous breast cancer * Neoadjuvant chemotherapy or chemotherapy for another breast cancer within two years

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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.

Breast cancer

Contacts and locations

Locations

  • Columbia

    New York, New York, 10032, United States

  • Comprehensive Breast Care of Denver

    Denver, Colorado, 80218, United States

  • Sharp Oncology (Comprehensive Breast Care of San Diego)

    San Diego, California, 92123, United States

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • University of Arizona

    Tucson, Arizona, 85704, United States

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205, United States

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