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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 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

216

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Zhenggui Du
  • Numero di telefono: +86 13880768222
  • Email: docduzg@163.com

Backup dei contatti dello studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Procedura: 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.
Comparatore attivo: 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.
Altro: 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).

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS)
Lasso di tempo: 5 years post-randomization
Time from randomization to death from any cause.
5 years post-randomization

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Overall Survival (OS)
Lasso di tempo: 3 and 10 years post-randomization
Time from randomization to death from any cause.
3 and 10 years post-randomization
Progression-Free Survival (PFS)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

West China Hospital

Collaboratori

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

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 settembre 2031

Completamento dello studio (Stimato)

31 dicembre 2036

Date di iscrizione allo studio

Primo inviato

24 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

29 giugno 2026

Primo Inserito (Effettivo)

7 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

7 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

29 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 2026(194)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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.

Periodo di condivisione IPD

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

Criteri di accesso alla condivisione IPD

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.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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Condizioni

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