Surgery vs. No Surgery for Primary Tumor in De Novo Stage IV Breast Cancer With Solitary Bone Metastases
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorWest China Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Primary Tumor Resection
Procedure/SurgerySurgical 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.
Standard systemic therapy
Other interventionSystemic 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).
Treatment groups
216 Participants
are divided into 2 treatment groupsGroup A: Surgery GroupExperimental treatment 1 intervention
Group B: Non-Surgery GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Overall Survival (OS)
Time from randomization to death from any cause.
Time frame
5 years post-randomizationSecondary outcomes
1
Overall Survival (OS)
Time from randomization to death from any cause.
Time frame
3 and 10 years post-randomization2
Progression-Free Survival (PFS)
Time from randomization to first documented disease progression (local progression, regional recurrence, or new/ progressive distant metastases) or death from any cause.
Time frame
Up to 10 years post-randomization3
Breast Cancer-Specific Survival (BCSS)
Time from randomization to death due to breast cancer.
Time frame
Up to 10 years post-randomization4
Patient-Reported Outcomes (PROs)
Quality of life measured by the EORTC QLQ-C30 (global health status/QoL).
Time frame
Baseline, 6 months, 5 years, and 10 years post-randomization.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
West China Hospital
Lead sponsor
The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
The Nineth Hospital of Shenzhen, Longgang Center Hospital
Collaborator
Baotou Cancer Hospital
Collaborator
Hebei General Hospital
Collaborator
General Hospital of Ningxia Medical University
Collaborator
The First Hospital of Jilin University
Collaborator
Tangshan People's Hospital
Collaborator
Guangdong Women and Children Hospital
Collaborator
Nanchang People's Hospital
Collaborator
Cancer Hospital of Guangxi Medical University
Collaborator
Xinjiang Medical University Cancer Hospital
Collaborator
Anyang Tumor Hospital
Collaborator
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Collaborator
Shanxi Bethune Hospital
Collaborator
Hebei Medical University Fourth Hospital
Collaborator
The Affiliated Hospital of Qingdao University
Collaborator
Suzhou Municipal Hospital
Collaborator
Zhejiang Provincial People's Hospital
Collaborator
Hunan Cancer Hospital
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Shanxi Province Cancer Hospital
Collaborator
The First Hospital of Lanzhou University, Gansu, China
Collaborator
Lanzhou University Second Hospital
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: