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
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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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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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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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Ingen indgriben: systemic therapy alone
breast cancer patients with oligometastasis receiving standard systemic chemo therapy ,hormone therapy or immunotherapy
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Overall survival
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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1. Quality of life of breast cancer patients after intervention versus usual care(chemotherapy)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: GHAZIA QASMI, FCPS SURGERY, SHARIF MEDICAL AND DENTAL COLLEGE, LAHORE.PAKISTAN
- Studieleder: HAROON J. MAJID, FRCS SURGERY, SHARIF MEDICAL AND DENTAL COLLEGE LAHORE,PAKISTAN
Publikationer og nyttige links
Generelle publikationer
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- SMDC/SMRC/409-26
- SharifMRC (Anden identifikator: Sharif medical and dental college Lahore Pakistan)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
IPD-delingsadgangskriterier
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- ICF
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