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Surgery vs. No Surgery for Primary Tumor in De Novo Stage IV Breast Cancer With Solitary Bone Metastases (POSITIVE-Bone)

29. juni 2026 opdateret af: Du Zhenggui, West China Hospital

A National Multicenter, Prospective, Randomized Controlled Trial Comparing Primary Tumor Surgery Followed by Systemic Therapy With Systemic Therapy Alone in Patients With De Novo Stage IV Breast Cancer and Solitary Bone Metastases

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The value of primary tumor resection in de novo stage IV breast cancer (BC) remains debated. While early retrospective studies suggested a potential survival benefit, recent large-scale randomized controlled trials (e.g., JCOG1017, E2108) have shown no OS benefit for the overall stage IV BC population. However, exploratory subgroup analyses consistently point towards a potential benefit for patients with hormone receptor-positive (HR+) disease and low metastatic burden, such as solitary bone metastases.

Given the unique biological behavior of HR+ BC and the effectiveness of modern systemic therapies (e.g., endocrine therapy + CDK4/6 inhibitors), it is hypothesized that primary tumor surgery may provide an additional "consolidation" benefit in this specific subgroup by improving local control and potentially prolonging survival. To address this, our team has designed this national multicenter, prospective, randomized controlled trial.

This study will enroll patients with de novo stage IV BC confirmed to have only bone metastases. All participants will receive standard systemic therapy based on their molecular subtype. Participants will be randomized 1:1 to either undergo primary tumor surgery (mastectomy or breast-conserving surgery with or without immediate reconstruction) within 4 weeks of randomization, followed by continued systemic therapy, or to receive systemic therapy alone. Palliative radiotherapy for bone metastases is permitted in both arms. The primary endpoint is 5-year overall survival. Secondary endpoints include PFS, BCSS, local control rate, quality of life (BREAST-Q, QLQ-C30), surgical complication rates, and cost analysis. This study will provide high-level evidence to guide personalized treatment decisions for this specific patient subgroup in China.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

216

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Surgery Group
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
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.
Aktiv komparator: Non-Surgery Group
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.
Andet: Standard systemic therapy
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).

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: 5 years post-randomization
Time from randomization to death from any cause.
5 years post-randomization

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overall Survival (OS)
Tidsramme: 3 and 10 years post-randomization
Time from randomization to death from any cause.
3 and 10 years post-randomization
Progression-Free Survival (PFS)
Tidsramme: Up to 10 years post-randomization
Time from randomization to first documented disease progression (local progression, regional recurrence, or new/ progressive distant metastases) or death from any cause.
Up to 10 years post-randomization
Breast Cancer-Specific Survival (BCSS)
Tidsramme: Up to 10 years post-randomization
Time from randomization to death due to breast cancer.
Up to 10 years post-randomization
Patient-Reported Outcomes (PROs)
Tidsramme: Baseline, 6 months, 5 years, and 10 years post-randomization.
Quality of life measured by the EORTC QLQ-C30 (global health status/QoL).
Baseline, 6 months, 5 years, and 10 years post-randomization.
Patient-Reported Outcomes (PROs)
Tidsramme: Baseline, 6 months, 5 years, and 10 years post-randomization.
Quality of satisfaction measured by the BREAST-Q (psychosocial well-being, sexual well-being, and chest physical well-being) questionnaires.
Baseline, 6 months, 5 years, and 10 years post-randomization.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

West China Hospital

Samarbejdspartnere

Shanxi Province Cancer Hospital
Hunan Cancer Hospital
Hebei General Hospital
The Affiliated Hospital of Qingdao University
The First Affiliated Hospital of Zhengzhou University
The First Hospital of Jilin University
Hebei Medical University Fourth Hospital
General Hospital of Ningxia Medical University
Zhejiang Provincial People's Hospital
Tangshan People's Hospital
Anyang Tumor Hospital
Guangdong Women and Children Hospital
Cancer Hospital of Guangxi Medical University
Suzhou Municipal Hospital
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Baotou Cancer Hospital
The Second Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Lanzhou University Second Hospital
Shanxi Bethune Hospital
Xinjiang Medical University Cancer Hospital
The First Hospital of Lanzhou University, Gansu, China
Nanchang People's Hospital
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
The Nineth Hospital of Shenzhen, Longgang Center Hospital

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. september 2031

Studieafslutning (Anslået)

31. december 2036

Datoer for studieregistrering

Først indsendt

24. juni 2026

Først indsendt, der opfyldte QC-kriterier

29. juni 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2026(194)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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.

IPD-delingstidsramme

After publication of relevant research outputs, such as academic papers and books.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP

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