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Zapping cancer spots: new radiation strategy may extend current Drug's power

NCT ID NCT06260033

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 precise radiation (SBRT) can treat a few growing tumors in patients with ER+ breast cancer that has spread, allowing them to continue their current medication longer. About 18 adults with limited disease progression will receive SBRT and be monitored. The goal is to see if this approach delays the need to switch to a new drug.

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

About 18 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2024

Expected to finish

Oct 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

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: * Documented informed consent of the participant and/or legally authorized representative * Age: ≥ 18 years * Female or male * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Ability to read and understand English or Spanish for questionnaires * Histologically confirmed ER+ (any progesterone receptor \[PR\] and human epidermal growth factor receptor 2 \[HER2\] status is allowed) metastatic breast cancer * The presence of metastatic breast cancer at the time of study entry with progression in 1-4 lesions (including new lesions). Patients that have disease progression in the breast and/or ipsilateral axilla will be considered to have only 1 site of progression even if multiple nodules/lymph nodes are present. Patients with progression in \> 4 lesions are not allowed. Patients with current progression of malignant pleural effusions, malignant ascites, abdominal carcinomatosis, and/or lymphangitic pulmonary involvement are considered to have \> 4 metastases (Note that patients with a history of these conditions earlier in the disease course with no evidence of progression of these conditions are eligible.) * Evidence of extracranial disease progression in 1-4 discrete lesions will be defined by either of the following: * Progression of disease by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1 or PET Response Criteria in Solid Tumors (PERCIST) v 1.0 criteria OR * Progression of disease in at least 1 but up to 4 lesions as determined by the patient's treating oncologists such that the treating oncologist recommends changing to the next line systemic therapy. Note that a patient may not technically meet RECIST v 1.1 criteria for disease progression in this setting * SBRT must be feasible for all progressing lesions. Feasibility includes but is not limited to: * All progressing lesions must have distinct borders AND * Progressing lesions may not be located within 3 cm of previously irradiated critical structures such as the spinal cord, brachial plexus, brainstem, stomach, and/or small/large bowel that would render the metastasis unsafe to target with SBRT per the treating radiation oncologist * Patients with prior treated brain metastases that are stable are allowed. Patients must not have intracranial disease progression. Patients with prior or current leptomeningeal disease are not allowed * All progressing lesions must be amenable to stereotactic body radiation therapy to a dose of 30 Gy to 40 Gy in 3 to 5 fractions per the treating radiation oncologist * Women of childbearing potential (WOCBP): Negative urine or serum pregnancy test, If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required * Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 1 months after the last dose of protocol therapy. * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) Exclusion Criteria: * Has received at least one line, but not more than three lines, of systemic therapy for metastatic disease * Patients may not have received chemotherapy, radiation therapy, biological therapy, immunotherapy, or other anti-cancer treatment within 7-14 days of the start of study therapy (SBRT) at the discretion of treating physician. Chemotherapy must be held during study therapy and can resume 7-14 days after completion of all study therapy (SBRT) at the discretion of treating physician. (Patients may continue anti-endocrine/hormone therapy before, during and after study therapy at the discretion of the treating medical oncologist.) * Clinically significant uncontrolled illness such that the patient is no longer a candidate for systemic therapy * Prior or concurrent malignancy. Prior malignancies with a low probability of recurrence requiring treatment such as the following are allowed: carcinoma in situ of the cervix, non-melanoma skin cancer, and low grade (Gleason score ≤ 6 = Gleason group 1) localized prostate cancer. Prior malignancies not listed require principal investigator (PI) approval * Patients that have only liver metastases will not be allowed * Females only: Pregnant or breastfeeding * Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • City of Hope Medical Center

    RECRUITING

    Duarte, California, 91010, United States

  • City of Hope at Irvine Lennar

    RECRUITING

    Irvine, California, 92618, United States

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