Effectiveness of Surgery for Improving Survival in Oligometastatic Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: surgery in accordance with current clinical guidelines, modified radical mastectomy or breast conservation surgery.
- Who it may be relevant to
- Registry conditions: Survival Outcomes. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effectiveness of Primary Tumour Surgery in Oligometastatic Breast Cancer for Improving Overall Survival: A Quasi-Experimental Study
Overview
Breast cancer is the most common malignancy in women, with stage IV disease at diagnosis in 5-10% of cases. Oligometastatic breast cancer (OMBC), defined as limited metastases (≤3-5 in ≤1-2 organs), may have better outcomes. Systemic therapy is the cornerstone of treatment, while the role of surgery or radiotherapy for the primary tumour remains controversial. Current European Society for Medical Oncology(ESMO )and National Comprehensive Cancer Network(NCCN) guidelines advise systemic therapy as standard, reserving surgery mainly for palliation of local disease. Few Retrospective studies offering primary tumour surgery to oligometastatic breast cancer responding to systemic therapy suggest survival benefit, but several randomised trials to date showed inconsistent results. In Pakistan, data regarding survival pattern after breast surgery in oligometastatic breast cancer are scanty and this study would bridge this knowledge gap.
Detailed description
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.
Interventions
- Procedure surgery in accordance with current clinical guidelines
MRM or BCS - Procedure modified radical mastectomy or breast conservation surgery
patients who receive systemic therapy and respond to treatment will undergo modified radical mastectomy or breast conservation surgery
Primary outcome measures
- Overall survival [Time frame: 3 years]
Secondary outcome measures (1)
- 1. Quality of life of breast cancer patients after intervention versus usual care(chemotherapy) [Time frame: 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Pakistan · 1 center
- Department of Surgery and Surgical Oncology — Lahore
Publications
- 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. PMID 33093581
- 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. PMID 39618499
- 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. PMID 26363985
- 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. PMID 33227574
- 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 Practic PMID 34678411
- 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. PMID 38048724
- 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. PMID 36549169
- 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. PMID 41501299
Identifiers
NCT: NCT07586319 · SMDC/SMRC/409-26 · SharifMRC