Survival OutcomesSASI-MBCNCT07586319
Effectiveness of Surgery for Improving Survival in Oligometastatic Breast Cancer Patients
A study testing surgery in accordance with current clinical guidelines and modified radical mastectomy or breast conservation surgery in people with Survival Outcomes, run by Sharif Medical Research Center at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Survival Outcomes
- What is being tested?
- surgery in accordance with current clinical guidelines and modified radical mastectomy or breast conservation surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2026to 1 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unfit for surgery
- Prior locoregional surgery on primary tumor
- Visceral crisis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Department of Surgery and Surgical Oncology
Lahore, Punjab Province, 54910
About this study
Official title: 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.
Read the 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.
- Conditions
- Survival Outcomes
- Being tested
- surgery in accordance with current clinical guidelines, modified radical mastectomy or breast conservation surgery
- Keywords
- oligometastatic, breast cancer,survival,role of surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery in accordance with current clinical guidelinesProcedure or surgery
MRM or BCS
modified radical mastectomy or breast conservation surgeryProcedure or surgery
patients who receive systemic therapy and respond to treatment will undergo modified radical mastectomy or breast conservation surgery
| Study group | Role | What they receive |
|---|---|---|
| breast surgery intervention group | Experimental | 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 Receives: Procedure: surgery in accordance with current clinical guidelines; Procedure: modified radical mastectomy or breast conservation surgery |
| systemic therapy alone | No intervention | breast cancer patients with oligometastasis receiving standard systemic chemo therapy ,hormone therapy or immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
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.
Measured: 3 years
Secondary outcomes (1)
1. Quality of life of breast cancer patients after intervention versus usual care(chemotherapy)
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).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Jun 2028 (estimated)
- Study completion1 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Survival OutcomesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sharif Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ghazia Qasmi, Sharif Medical Research Center
- Investigators
- GHAZIA QASMI, FCPS SURGERY, Principal investigator, SHARIF MEDICAL AND DENTAL COLLEGE, LAHORE.PAKISTANHAROON J. MAJID, FRCS SURGERY, Study director, SHARIF MEDICAL AND DENTAL COLLEGE LAHORE,PAKISTAN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07586319
- Sponsor's protocol ID
- SMDC/SMRC/409-26
- Other IDs
- SharifMRC
- Acronym
- SASI-MBC
- Status last verified
- May 2026
- First submitted
- 23 Apr 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: results of surgical intervention as overall and progression free survival.quality of life proforma results,patients demographics, treatment given
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.
PubMed 33093581Wu 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.
PubMed 39618499Badwe 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.
PubMed 26363985Pons-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.
PubMed 33227574Gennari 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.
PubMed 34678411Ren 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.
PubMed 38048724van 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.
PubMed 36549169Chen 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.
PubMed 41501299
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Primary Tumour Surgery in Oligometastatic Breast Cancer for Improving Overall Survival: A Quasi-Experimental Study
- ClinicalTrials.gov ID
- NCT07586319
- Acronym / sponsor ID
- SASI-MBC / SMDC/SMRC/409-26
- Conditions
- Survival Outcomes
- Keywords
- oligometastatic, breast cancer,survival,role of surgery
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Sharif Medical Research CenterUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Jun 2028 (estimated)
- Study completion
- 1 Jun 2031 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| breast surgery intervention group | Experimental | Procedure: surgery in accordance with current clinical guidelines, Procedure: modified radical mastectomy or breast conservation surgerybreast 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 |
| systemic therapy alone | No intervention | –breast cancer patients with oligometastasis receiving standard systemic chemo therapy ,hormone therapy or immunotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Unfit for surgery
- Prior locoregional surgery on primary tumor
- Visceral crisis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| surgery in accordance with current clinical guidelinesMRM or BCS | Procedure or surgery | breast surgery intervention group |
| modified radical mastectomy or breast conservation surgerypatients who receive systemic therapy and respond to treatment will undergo modified radical mastectomy or breast conservation surgery | Procedure or surgery | breast surgery intervention group |
Primary outcome
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.
1 secondary outcome
1. Quality of life of breast cancer patients after intervention versus usual care(chemotherapy)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Background: PubMed 33093581Ma 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.
- Background: PubMed 39618499Wu 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.
- Background: PubMed 26363985Badwe 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.
- Background: PubMed 33227574Pons-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.
- Background: PubMed 34678411Gennari 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.
- Background: PubMed 38048724Ren 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.
- Background: PubMed 36549169van 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.
- Background: PubMed 41501299Chen 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.
- ESMO Living Guideline: Metastatic Breast Cancer. ESMO.org. 2025.Link provided by the sponsor.
- NCCN Clinical Practice Guidelines in Oncology: Metastatic Breast Cancer. NCCN.org. 2025.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. results of surgical intervention as overall and progression free survival.quality of life proforma results,patients demographics, treatment given
Related trials for Survival Outcomes
Not yet recruitingObservational study
Therapeutic Outcomes of In-Hospital Resuscitation of Patients Admitted to the Internal Medicine Wards
Survival to Discharge With Good Neurologic Outcome Among in Hospital Cardiac Arrest Patients
Not yet recruitingObservational study
Multiple Myeloma Extramedulary Disease Samples FFPE
Multiple Myeloma Survival Outcome, Multiple Myeloma and Malignant Plasma Cell Neoplasms
Active, not recruitingObservational study
Response Times in Danish Emergency Medical Services
Emergency Medical Services, Response
RecruitingObservational study
Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastrectomies for Gastric Cancer (PhotoNodes)
Gastric Cancer, Gastric Adenocarcinoma
Not yet recruitingObservational study
A Prospective Cohort Study Comparing Disparity in Surgical Procedure (Wide Local Excision Only vs Any Other Surgery Procedures) Among the Elderly Breast Cancer Patients
Breast Cancer, Elderly Patient
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
GHAZIA QASMI, FCPS SURGERY principal investigator
SHARIF MEDICAL AND DENTAL COLLEGE, LAHORE.PAKISTAN
HAROON J. MAJID, FRCS SURGERY study director
SHARIF MEDICAL AND DENTAL COLLEGE LAHORE,PAKISTAN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing surgery in accordance with current clinical guidelines and modified radical mastectomy or breast conservation surgery in people with Survival Outcomes, run by Sharif Medical Research Center at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07586319, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.