Status:
COMPLETED
Assessing Impact of Loco-regional Treatment on Survival in Metastatic Breast Cancer at Presentation
Lead Sponsor:
Tata Memorial Hospital
Conditions:
Cancer of the Breast
Eligibility:
FEMALE
21-65 years
Phase:
NA
Brief Summary
Traditionally metastatic breast cancer patients are not offered loco-regional treatment except in cases of fungation or bleeding. However, scientific evidence for such omission of loco-regional treatm...
Detailed Description
PRESENT KNOWLEDGE: Loco-regional treatment should not be attempted in metastatic breast cancer patients is a traditional teaching, which lacks scientific basis. Omission of loco-regional treatment ca...
Eligibility Criteria
Inclusion
- Metastatic breast cancer at first presentation with an expected survival of at least one year
Exclusion
- Patients who are not fit to receive anthracycline based chemotherapy.
- More than two visceral organ involvement.
- Multiple liver metastases with deranged liver function tests (SGOT/SGPT more than four times the upper normal limit).
- Locally static or progressive disease or systemically progressive disease as shown by repeat staging investigations guided by worsening symptoms.
- Ulceration/ fungation/ bleeding after completion of chemotherapy, which mandates surgery.
- Expected survival of less than six months after completion of chemotherapy.
- Unfit for anaesthesia due to metastatic disease.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 30 2020
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT00193778
Start Date
February 1 2005
End Date
July 30 2020
Last Update
October 8 2020
Active Locations (1)
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1
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400 012