Surgery vs. No Surgery for Primary Tumor in De Novo Stage IV Breast Cancer With Solitary Bone Met… (NCT07687225) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Surgery vs. No Surgery for Primary Tumor in De Novo Stage IV Breast Cancer With Solitary Bone Metastases
216 participantsStarted 2026-09-01
Plain-language summary
This is a national multicenter, prospective, randomized controlled trial. The study aims to compare the 5-year overall survival (OS) between patients receiving primary tumor surgery followed by systemic therapy (surgery group) and those receiving systemic therapy alone (non-surgery group) in patients with de novo Stage IV breast cancer who have solitary bone metastases. Secondary objectives include comparing progression-free survival (PFS), breast cancer-specific survival (BCSS), local control rates, patient-reported outcomes (BREAST-Q, QLQ-C30), safety (surgical complications and systemic therapy toxicities), and cost-effectiveness.
Who can participate
Age range
18 Years – 70 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing surgery to remove the primary breast tumor versus no surgery for stage IV breast cancer with a single bone metastasis — given my specific situation, does my doctor think surgery on the primary tumor could realistically help me, or is systemic treatment alone the more established path right now?
2Since this trial isn't recruiting yet, how long might it be before I could even enroll, and is it safe for me to wait, or do I need to start treatment sooner?
3The trial is measuring overall survival as its main outcome, which means the benefit of surgery in this setting isn't yet proven — can my doctor walk me through what the current evidence does and doesn't show about removing the primary tumor when the cancer has already spread to a bone?
4Because this involves a real surgical procedure as one of the arms, what would recovery look like for me personally, and how might that affect my ability to receive systemic treatments like chemotherapy or hormone therapy at the same time?
5Are there other clinical trials or standard-of-care options already available to me that I should consider alongside or instead of this one, especially since this study hasn't started enrolling yet?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.