Survival benefit of giving radiation treatment to breast and lymph nodes verses no radiation treatment to breast and lymph nodes in Stage IV Breast Cancer

Phase 3

Conditions: Health Condition 1: C508- Malignant neoplasm of overlappingsites of breast

Registration Number: CTRI/2022/06/043551

Lead Sponsor: Cancer Institute WIA

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

Inclusion Criteria

1.All female patients with histologically proven or radiologically confirmed MBC

2.Age between 18-70 years

3.Estimated life expectancy of at least 1 year during the time of recruitment in the study

4.Karnofsky performance status score >=60.

5.Normal cardiac function with echocardiography showing Ejection Fraction (EF) 50% or more.

6.The subset of oligometastatic patients who, after the completion of systemic therapy, continue to remain inoperable or have oligometastatic disease not amenable for local treatments and are not offered MRM will be considered for the trial

Exclusion Criteria

1.Any previous history of cancer treatment

2.Patients with oligo-metastasis amenable for curative intent of treatment and treated with MRM followed by sequential RT

3.Patients with symptomatic brain metastasis with features of raised intracranial pressure at the time of study recruitment

4.Patients with multiple liver metastasis and grossly deranged LFT (SGOT (AST) > 4.0 x upper limit of normal (ULN) and SGPT (ALT) >4.0 x ULN and Bilirubin >1.5 x ULN) at the time of study recruitment

5.Patients with significant residual disease post systemic therapy at the time of randomization who will require palliative RT for local control

6.Patients with extensive cutaneous nodules and disease extending beyond the confines of the breast and impossible to encompass within the radiation fields during study recruitment

7.History of previous radiation therapy to the affected breast

8.Patients not consenting to treatment

9.The patient is mentally incapacitated or has a significant emotional or psychiatric disorder that, in the opinion of the investigator, precludes study entry.