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Could removing the primary tumor boost survival in stage IV breast cancer with Bone-Only spread?

NCT ID NCT07687225

Disease control Sponsor: West China Hospital 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 07, 2026 · Last updated Jul 08, 2026 · Updated 1 time

Summary

This trial investigates whether surgically removing the primary breast tumor, followed by standard systemic therapy, improves survival compared to systemic therapy alone in women with stage IV breast cancer that has spread only to a single bone site. The study enrolls women aged 18 to 70 with newly diagnosed or first-line-treated disease. Researchers will track overall survival, cancer progression, quality of life, and treatment side effects over five years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Primary tumor resection (surgery)
What this could lead to
If surgery plus systemic therapy improves survival, it could become a new standard approach for patients with stage IV breast cancer that has spread only to bone.
What could go wrong
This is a randomized trial, but the benefit of surgery in stage IV cancer is unproven. Surgery carries risks like infection or complications, and the cancer may still progress despite treatment.

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

About 216 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Dec 2036

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 to 70 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: * Female patients aged 18 to 70 years (inclusive); * Histopathologically confirmed (by core needle biopsy) invasive breast cancer; * Diagnosed with de novo Stage IV breast cancer with metastases confirmed to be limited to bone; * Patients may be enrolled either at initial diagnosis or after receiving first-line systemic therapy; * Willing and able to provide written informed consent. Exclusion Criteria: * Disease progression (per RECIST 1.1 criteria) in the primary tumor, regional lymph nodes, or bone metastases after first-line systemic therapy; * Presence of other primary malignancies; * Severe comorbidities that would preclude surgery or safe administration of systemic therapy (e.g., severe cardiopulmonary disease, uncontrolled diabetes, long-term smoking history with poor pulmonary function, immunodeficiency); * Current participation in another clinical trial that would interfere with the outcomes of this study; * Refusal to provide informed consent.

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm metastatic carcinoma in the bone

As listed by the trial registrant

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

Bone metastases Breast cancer Stage IV breast cancer

How to take part

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

  1. 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 ↗

  2. 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.

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