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
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习地点
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Punjab Province
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Lahore、Punjab Province、巴基斯坦、54910
- Department of Surgery and Surgical Oncology
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的: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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无干预:systemic therapy alone
breast cancer patients with oligometastasis receiving standard systemic chemo therapy ,hormone therapy or immunotherapy
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Overall survival
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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1. Quality of life of breast cancer patients after intervention versus usual care(chemotherapy)
大体时间: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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合作者和调查者
调查人员
- 首席研究员:GHAZIA QASMI, FCPS SURGERY、SHARIF MEDICAL AND DENTAL COLLEGE, LAHORE.PAKISTAN
- 研究主任:HAROON J. MAJID, FRCS SURGERY、SHARIF MEDICAL AND DENTAL COLLEGE LAHORE,PAKISTAN
出版物和有用的链接
一般刊物
- 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.
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- SMDC/SMRC/409-26
- SharifMRC (其他标识符:Sharif medical and dental college Lahore Pakistan)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
IPD 共享时间框架
IPD 共享访问标准
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
药物和器械信息、研究文件
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研究美国 FDA 监管的设备产品
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