Effectiveness of Surgery for Improving Survival in Oligometastatic Breast Cancer Patients (SASI-MBC)
Effectiveness of Primary Tumour Surgery in Oligometastatic Breast Cancer for Improving Overall Survival: A Quasi-Experimental Study
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Oligometastatic breast cancer (OMBC) is an entity is metastatic breast cancer with limited tumour burden. Usual nomenclature suggests total number of metastases to be less than 5 in up to 3 organs. It is considered an intermediate stage between localised and metastatic breast cancer. As compared to Multi metastatic stage 4 breast cancer oligometastatic breast cancer may have a favourable outcome (1,3) Currently the standard treatment for OMBC is systemic therapy (chemotherapy, hormone therapy or immunotherapy), with surgery or radiotherapy to primary tumour and metastatic sites as palliation only, as per ESMO and NCCN guidelines. (4,5) Retrospective observational studies suggested a possible survival benefit with primary tumour surgery (6,7). On the other hand, several Randomised controlled trials (Badwe et al., MF07-01, ECOG-ACRIN E2108, ABCSG-28) have shown inconsistent overall survival benefit with surgery in de novo metastatic breast cancer (8-10). The survival benefit has been observed where primary tumor surgery was performed in patients who respond well to systemic therapy in the form of complete or partial radiological response of metastasis, especially in patients with low metastatic burden, bone-only disease, or favorable biology may have differential outcomes after surgery (9,11).
Existing evidence is conflicting. So, case to case-based decision is being made for the oligometastatic breast cancer patients. There is a knowledge gap specific to oligometastatic disease among Pakistani patients as well. There are few Pakistani studies on this research question (12) The objective of this study is to determine whether surgical resection of the primary tumour in addition to standard systemic therapy improves overall survival compared with systemic therapy alone in patients with oligometastatic breast cancer.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54910
- Department of Surgery and Surgical Oncology
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Age ≥18 years
- Histologically confirmed breast carcinoma
- Oligometastatic disease (≤5 lesions, less than 3 organs)
- ECOG performance status 0-2
- Eligible for systemic therapy and surgery
- Informed consent obtained
Exclusion Criteria:
- Unfit for surgery
- Prior locoregional surgery on primary tumor
- Visceral crisis
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: breast surgery intervention group
breast cancer patients with metastasis who receive standard systemic therapy and have complete or partial radio logical response to metastatic deposits will be offered modified radical mastectomy or Breast conservation surgery in intervention group patients
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MRM or BCS
patients who receive systemic therapy and respond to treatment will undergo modified radical mastectomy or breast conservation surgery
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Aucune intervention: systemic therapy alone
breast cancer patients with oligometastasis receiving standard systemic chemo therapy ,hormone therapy or immunotherapy
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Overall survival
Délai: 3 years
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Primary outcome measure of study will be overall survival in oligometastatic breast cancer patients after surgical intervention with chemotherapy versus chemotherapy alone. The time from intervention to the time of end point (death of patient) will be measured using this data through Kaplan Meier survival curve and using Cox regression model. We shall calculate:
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3 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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1. Quality of life of breast cancer patients after intervention versus usual care(chemotherapy)
Délai: 3 years
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QUALITY of life will be measured using EORTIC QUALITY OF LIFE QUESTIONNAIRE -BR 42 (QOL-42) Baseline quality of life of participants and the change in quality of life after intervention will be recorded.
Patients will be interviewed after 3-months,6-months and then yearly.
This tool assesses functional and symptom level domains on the scale of 0 to 100(better function=close to100; worse symptoms=close to100).
Each item is scored from 1 to 4 (1 = not at all, 2= a little,3= quite a bit,4= very much).
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3 years
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: GHAZIA QASMI, FCPS SURGERY, SHARIF MEDICAL AND DENTAL COLLEGE, LAHORE.PAKISTAN
- Directeur d'études: HAROON J. MAJID, FRCS SURGERY, SHARIF MEDICAL AND DENTAL COLLEGE LAHORE,PAKISTAN
Publications et liens utiles
Publications générales
- Gennari A, Andre F, Barrios CH, Cortes J, de Azambuja E, DeMichele A, Dent R, Fenlon D, Gligorov J, Hurvitz SA, Im SA, Krug D, Kunz WG, Loi S, Penault-Llorca F, Ricke J, Robson M, Rugo HS, Saura C, Schmid P, Singer CF, Spanic T, Tolaney SM, Turner NC, Curigliano G, Loibl S, Paluch-Shimon S, Harbeck N; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Ann Oncol. 2021 Dec;32(12):1475-1495. doi: 10.1016/j.annonc.2021.09.019. Epub 2021 Oct 19. No abstract available.
- Ma L, Mi Y, Cui S, Wang H, Fu P, Yin Y, Jin F, Li J, Liu Y, Fan Z, Zhang H, Geng C, Jiang Z. Role of locoregional surgery in patients with de novo stage IV breast cancer: analysis of real-world data from China. Sci Rep. 2020 Oct 22;10(1):18132. doi: 10.1038/s41598-020-75119-0.
- Wu C, Li X, Liu S, Yao L, He T, Wang Y, Dong H, Niu S, Wang M, Xu Y. Primary tumor resection in de novo metastatic breast cancer from an oligometastatic perspective: A systematic review and meta-analysis. iScience. 2024 Oct 31;27(12):111224. doi: 10.1016/j.isci.2024.111224. eCollection 2024 Dec 20.
- Badwe R, Hawaldar R, Nair N, Kaushik R, Parmar V, Siddique S, Budrukkar A, Mittra I, Gupta S. Locoregional treatment versus no treatment of the primary tumour in metastatic breast cancer: an open-label randomised controlled trial. Lancet Oncol. 2015 Oct;16(13):1380-8. doi: 10.1016/S1470-2045(15)00135-7. Epub 2015 Sep 9.
- Pons-Tostivint E, Alouani E, Kirova Y, Dalenc F, Vaysse C. Is there a role for locoregional treatment of the primary tumor in de novo metastatic breast cancer in the era of tailored therapies?: Evidences, unresolved questions and a practical algorithm. Crit Rev Oncol Hematol. 2021 Jan;157:103146. doi: 10.1016/j.critrevonc.2020.103146. Epub 2020 Nov 12.
- Ren C, Sun J, Kong L, Wang H. Breast surgery for patients with de novo metastatic breast cancer: A meta-analysis of randomized controlled trials. Eur J Surg Oncol. 2024 Jan;50(1):107308. doi: 10.1016/j.ejso.2023.107308. Epub 2023 Dec 1.
- van Ommen-Nijhof A, Steenbruggen TG, Capel L, Vergouwen M, Vrancken Peeters MT, Wiersma TG, Sonke GS. Survival and prognostic factors in oligometastatic breast cancer. Breast. 2023 Feb;67:14-20. doi: 10.1016/j.breast.2022.12.007. Epub 2022 Dec 14.
- Chen EL, Heiling H, Li T, Bellon JR, Nakhlis F, Parsons HA, Martin A, Burstein HJ, Tolaney SM, Snow C, Tayob N, Braunstein LZ, Lin NU, Sammons S. Outcomes of patients with de novo oligometastatic breast cancer treated with curative intent at a single institution. Breast Cancer Res Treat. 2026 Jan 8;215(2):55. doi: 10.1007/s10549-025-07889-y.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SMDC/SMRC/409-26
- SharifMRC (Autre identifiant: Sharif medical and dental college Lahore Pakistan)
Plan pour les données individuelles des participants (IPD)
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Description du régime IPD
Délai de partage IPD
Critères d'accès au partage IPD
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- CIF
Informations sur les médicaments et les dispositifs, documents d'étude
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