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Enrolling by Invitation

NCT Number: NCT07586319

Effectiveness of Surgery for Improving Survival in Oligometastatic Breast Cancer Patients

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.

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Key information

Conditions

Survival Outcomes Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Surgery and Surgical Oncology

Lahore, Punjab Province, 54910, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

surgery in accordance with current clinical guidelines

Procedure

MRM or BCS

modified radical mastectomy or breast conservation surgery

Procedure

patients who receive systemic therapy and respond to treatment will undergo modified radical mastectomy or breast conservation surgery

Primary outcomes

  1. Overall survival

    Time frame: 3 years

    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:

    • Median survival
    • 3-year survival rate
    • Disease specific survival
    • Progression free Survival (PFS): Time from intervention to the progression will be measured using Kaplan-Meier survival method. End point of follow-up will be worsening of lesion, or appearance of new lesion, or death. We shall use RECIST criteria to record tumor change
    • Survival rate Total number of patients given intervention plus chemotherapy versus chemotherapy alone as denominator and total number of patients survived during follow-up time as numerator. Hazard Ratio will compare the risk of dying among intervention compared to control group.

Secondary outcomes

  1. 1. Quality of life of breast cancer patients after intervention versus usual care(chemotherapy)

    Time frame: 3 years

    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).

Sponsors and collaborators

Lead sponsor

Sharif Medical Research Center

Other

Registry information

Official study title

Effectiveness of Primary Tumour Surgery in Oligometastatic Breast Cancer for Improving Overall Survival: A Quasi-Experimental Study

Acronym: SASI-MBC

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
May 14, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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