Effectiveness of Surgery for Improving Survival in Oligometastatic Breast Cancer Patients (SASI-MBC)

May 17, 2026 updated by: Ghazia Qasmi, Sharif Medical Research Center

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan, 54910
        • Department of Surgery and Surgical Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
No Intervention: systemic therapy alone
breast cancer patients with oligometastasis receiving standard systemic chemo therapy ,hormone therapy or immunotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sharif Medical Research Center

Collaborators

Institute of Nuclear Medicine and Allied Sciences

Investigators

  • Principal Investigator: GHAZIA QASMI, FCPS SURGERY, SHARIF MEDICAL AND DENTAL COLLEGE, LAHORE.PAKISTAN
  • Study Director: HAROON J. MAJID, FRCS SURGERY, SHARIF MEDICAL AND DENTAL COLLEGE LAHORE,PAKISTAN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2031

Study Registration Dates

First Submitted

April 23, 2026

First Submitted That Met QC Criteria

May 12, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 17, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMDC/SMRC/409-26
  • SharifMRC (Other Identifier: Sharif medical and dental college Lahore Pakistan)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

results of surgical intervention as overall and progression free survival.quality of life proforma results,patients demographics, treatment given

IPD Sharing Time Frame

from march 2031 onwards

IPD Sharing Access Criteria

researchers through published paper

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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