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To asses the Impact of loco-regional treatment on survival of patients with metastatic breast cancer at first presentation.

A Randomized Trial to assess impact of loco-regional treatment on survival of patients with metastatic breast cancer at first presentation. - M1 Study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/07/002805
Enrollment
350
Registered
2012-07-16
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Patient with metastatic breast cancer at first presentation.

Interventions

Intervention1: Locoregional Treatment (LRT): Locoregional Treatment group patients will receive standard loco-regional (LRT)treatment i.e. surgery (modified radical mastectomy (MRM)/ Simple SMAC/BCT)

Sponsors

Tata Memorial Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Metastatic breast cancer patients with expected survival of at least one year

Exclusion criteria

Exclusion criteria: 1.Patients who are not fit to receive anthracycline / taxane based chemotherapy. 2.More than two visceral organ involvements. 3.Multiple liver metastases with deranged liver function tests (SGOT/SGPT more than four times the upper normal limit). 4.Locally static or progressive disease or systemically progressive disease as shown by repeat staging investigations guided by worsening symptoms. 5.Ulceration/ fungation/ bleeding after completion of chemotherapy, which mandates surgery. 6.Expected survival of less than six months after completion of chemotherapy. 7.Unfit for anaesthesia due to metastatic disease.

Design outcomes

Primary

MeasureTime frame
1.To assess impact of loco-regional treatment on survival in metastatic breast cancer patientsTimepoint: 3 years

Secondary

MeasureTime frame
To assess impact of loco-regional treatment on levels of VEGF, bFGF, Angiostatin, Endostatin in blood of metastatic breast cancer patients. Timepoint: 5 years

Countries

India

Contacts

Public ContactMs Rohini Hawaldar

Tata Memorial Hospital

badwera@gmail.com02224168601

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026