Assessing Impact of Loco-Regional Treatment on Survival in Metastatic Breast Cancer at Presentation

This study is currently recruiting participants.

Verified by Tata Memorial Hospital, May 2008

First Received: September 12, 2005 Last Updated: May 1, 2008 History of Changes

Sponsored by:	Tata Memorial Hospital
Information provided by:	Tata Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00193778

Purpose

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 treatment in metastatic breast cancer patients is lacking. On one hand, studies have shown that removal of primary tumor at times leads to complete disappearance of metastases and improvement in survival in renal cell carcinoma patients. However, such studies have never been performed in other solid tumors. On the other hand, there is a strong body of evidence in experimental settings that show that removal of primary tumor allows growth of metastasis. There is lack of similar data in humans in clinical settings. Offering loco-regional treatment in metastatic breast cancer patients in a setting of randomized controlled trial will help in improving survival of such patients and understanding the natural history of breast cancer.

Condition	Intervention	Phase
Cancer of the Breast	Procedure: Loco-regional treatment - Surgery &/or Radiation therapy	Phase III

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	A Randomized Trial To Assess The Impact Of Loco-Regional Treatment On Survival Of Patients With Metastatic Breast Cancer At First Presentation

Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:

Time to progression
Death

Secondary Outcome Measures:

Changes in VEGF, bFGF, Angiostatin and Endostatin

Estimated Enrollment:	350
Study Start Date:	February 2005
Estimated Study Completion Date:	February 2011

Show Detailed Description

Eligibility

Ages Eligible for Study:	21 Years to 65 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Metastatic breast cancer at first presentation with an expected survival of atleast one year

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193778

Contacts

Contact: Rajendra A Badwe, MS	91- 22-2417-7000 ext 7299	badwera@gmail.com
Contact: Vani Parmar, MS, DNB	91-22-2417-7000 ext 7194	vparmar@vsnl.net

Locations

India, Maharashtra
Tata Memorial Hospital	Recruiting
Mumbai, Maharashtra, India, 400 012
Contact: Rajendra A Badwe, MS 91-22-2417-7000 ext 7299 badwera@gmail.com
Contact: Vani Parmar, MS, DNB 91-22-2417-7000 ext 7194 vparmar@vsnl.net
Principal Investigator: Rajendra A Badwe, MS
Sub-Investigator: Vani Parmar, MS, DNB
Sub-Investigator: Ketayun A Dinshaw, MD
Sub-Investigator: Rajiv Sarin, MD
Sub-Investigator: Rakesh Jalali, MD
Sub-Investigator: Reena Nair, MD
Sub-Investigator: Sudeep Gupta, MD
Sub-Investigator: Meenakshi Thakur, MD
Sub-Investigator: Roshni Chinoy, MD
Sub-Investigator: Rohini Hawaldar, M.Sc
Sub-Investigator: Rooprekha Hegde, M.Sc, PhD
Sub-Investigator: Suresh Ramani, MD

Sponsors and Collaborators

Tata Memorial Hospital

Investigators

Principal Investigator:

Rajendra A Badwe, MS (Surgery)

Tata Memorial Hospital, Ernest Borges Road, Parel, Mumbai 400 012

More Information

No publications provided

Responsible Party:	Tata Memorial Hospital ( Dr R A Badwe )
Study ID Numbers:	TMH/153/2004
Study First Received:	September 12, 2005
Last Updated:	May 1, 2008
ClinicalTrials.gov Identifier:	NCT00193778 History of Changes
Health Authority:	India: Department of Atomic Energy

Keywords provided by Tata Memorial Hospital:

Metastatic breast cancer
Locoregional treatment
Survival

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009