NCT07687225

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
216

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
126mo left

Started Sep 2026

Longer than P75 for not_applicable breast-cancer

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2031

5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2036

Last Updated

July 7, 2026

Status Verified

June 1, 2026

Enrollment Period

5 years

First QC Date

June 24, 2026

Last Update Submit

June 29, 2026

Conditions

Breast CancerStage IV Breast CancerBone Metastases

Keywords

Breast CancerStage IVBone Metastasis

Outcome Measures

Primary Outcomes (1)

  • Overall Survival (OS)

    Time from randomization to death from any cause.

    5 years post-randomization

Secondary Outcomes (5)

  • Overall Survival (OS)

    3 and 10 years post-randomization

  • Progression-Free Survival (PFS)

    Up to 10 years post-randomization

  • Breast Cancer-Specific Survival (BCSS)

    Up to 10 years post-randomization

  • Patient-Reported Outcomes (PROs)

    Baseline, 6 months, 5 years, and 10 years post-randomization.

  • Patient-Reported Outcomes (PROs)

    Baseline, 6 months, 5 years, and 10 years post-randomization.

Study Arms (2)

Surgery Group

EXPERIMENTAL

Patients undergo primary tumor surgery (total mastectomy or breast-conserving surgery with sentinel lymph node biopsy or axillary lymph node dissection, with or without immediate breast reconstruction) within 4 weeks after randomization, followed by continued standard systemic therapy.

Procedure: Primary Tumor Resection

Non-Surgery Group

ACTIVE COMPARATOR

Patients receive standard systemic therapy alone based on their molecular subtype (e.g., HR+/HER2-: endocrine therapy ± CDK4/6 inhibitor; HER2+: anti-HER2 therapy + chemotherapy; Triple-negative: chemotherapy ± immunotherapy). Palliative local therapy (e.g., radiotherapy) for bone metastases or for managing severe local complications from the primary tumor (e.g., uncontrolled ulceration, bleeding) is permitted but not elective curative-intent primary tumor surgery.

Other: Standard systemic therapy

Interventions

Primary Tumor ResectionPROCEDURE

Surgical removal of the primary breast tumor. The procedure type (mastectomy or breast-conserving surgery) is determined by tumor size, location, and patient preference, and is performed by experienced breast surgeons following national guidelines. Axillary staging (sentinel node biopsy or dissection) is performed concurrently. Immediate breast reconstruction (prosthesis or autologous tissue) may be performed when indicated.

Surgery Group
Standard systemic therapyOTHER

Systemic treatment administered according to the patient's molecular subtype (HR+, HER2+, or Triple-negative) based on Chinese and international clinical guidelines. Regimens include, but are not limited to, endocrine therapy (e.g., letrozole, exemestane) with or without CDK4/6 inhibitors (e.g., palbociclib) for HR+/HER2- disease; anti-HER2 targeted therapy (e.g., trastuzumab, pertuzumab) combined with chemotherapy for HER2+ disease; and chemotherapy (e.g., taxanes, anthracyclines) with or without immunotherapy (e.g., pembrolizumab) for triple-negative disease. All patients with bone metastases routinely receive bone-modifying agents (zoledronic acid or denosumab).

Non-Surgery Group

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Zhenggui Du

CONTACT

+86 13880768222docduzg@163.com

Liuying Li

CONTACT

+86 13678020999lliuying99@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

June 24, 2026

First Posted

July 7, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

September 1, 2031

Study Completion (Estimated)

December 31, 2036

Last Updated

July 7, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

Qualified researchers can request access to anonymized individual patient-level data via the request portal. All IPD requests should be emailed to Dr. Zhenggui Du, the general project leader, and will be evaluated by Dr. Du and the head of the collaborating organization to decide whether to approve.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
After publication of relevant research outputs, such as academic papers and books.
Access Criteria
When a request has been approved, the investigator will provide access to the de-identified individual patient-level data in the data management platform (Electronic Data Capture, EDC). A signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing the requested information. Additionally, all users will need to accept the terms and conditions of the data management platform to gain access.
More information