Assessing Impact of Loco-regional Treatment on Survival in Metastatic Breast Cancer at Presentation - Full Text View

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: Surgery for breast cancer Other: No Loco-regional treatment	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Randomized Trial To Assess The Impact Of Loco-Regional Treatment On Survival Of Patients With Metastatic Breast Cancer At First Presentation

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Further study details as provided by Tata Memorial Hospital:

Primary Outcome Measures:

Overall survival and disease free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
OS : Time interval between randomiztion and death PFS : Time interval between randomization and progession of disease

Secondary Outcome Measures:

Changes in VEGF, bFGF, Angiostatin and Endostatin [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
The secondary endpoints include the assess of loco-regional treatment on levels of VEGF, bFGF, Angiostatin and Endostatin in blood of matastatic breast cancer patient after completion of the study.

Estimated Enrollment:	350
Study Start Date:	February 2005
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Loco Regional Treatment Arm (LRT) Surgery for breast cancer. (MRM/BCT)	Procedure: Surgery for breast cancer This group will receive standard loco-regional treatment i.e. surgery (modified radical mastectomy (MRM)/ Simple SMAC/BCT) +/- radiotherapy
Active Comparator: No Loco-regional Treatment Arm No surgery for Breast cancer	Other: No Loco-regional treatment This group will not receive any loco-regional treatment

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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 at least 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
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

Publications:

Lokich J. Spontaneous regression of metastatic renal cancer. Case report and literature review. Am J Clin Oncol. 1997 Aug;20(4):416-8. Review.

Flanigan RC, Salmon SE, Blumenstein BA, Bearman SI, Roy V, McGrath PC, Caton JR Jr, Munshi N, Crawford ED. Nephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer. N Engl J Med. 2001 Dec 6;345(23):1655-9.

Mickisch GH, Garin A, van Poppel H, de Prijck L, Sylvester R; European Organisation for Research and Treatment of Cancer (EORTC) Genitourinary Group. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet. 2001 Sep 22;358(9286):966-70.

Fisher B, Gunduz N, Coyle J, Rudock C, Saffer E. Presence of a growth-stimulating factor in serum following primary tumor removal in mice. Cancer Res. 1989 Apr 15;49(8):1996-2001.

Kim KJ, Li B, Winer J, Armanini M, Gillett N, Phillips HS, Ferrara N. Inhibition of vascular endothelial growth factor-induced angiogenesis suppresses tumour growth in vivo. Nature. 1993 Apr 29;362(6423):841-4.

Hori A, Sasada R, Matsutani E, Naito K, Sakura Y, Fujita T, Kozai Y. Suppression of solid tumor growth by immunoneutralizing monoclonal antibody against human basic fibroblast growth factor. Cancer Res. 1991 Nov 15;51(22):6180-4.

O'Reilly MS, Holmgren L, Shing Y, Chen C, Rosenthal RA, Moses M, Lane WS, Cao Y, Sage EH, Folkman J. Angiostatin: a novel angiogenesis inhibitor that mediates the suppression of metastases by a Lewis lung carcinoma. Cell. 1994 Oct 21;79(2):315-28.

O'Reilly MS, Holmgren L, Shing Y, Chen C, Rosenthal RA, Cao Y, Moses M, Lane WS, Sage EH, Folkman J. Angiostatin: a circulating endothelial cell inhibitor that suppresses angiogenesis and tumor growth. Cold Spring Harb Symp Quant Biol. 1994;59:471-82.

Responsible Party:	Dr Rajendra A. Badwe, Director, Tata Memorial Hospital
ClinicalTrials.gov Identifier:	NCT00193778 History of Changes
Other Study ID Numbers:	TMH/153/2004
Study First Received:	September 12, 2005
Last Updated:	June 21, 2012
Health Authority:	India: Department of Atomic Energy

Keywords provided by Tata Memorial Hospital:

Metastatic breast cancer
Locoregional treatment
Survival

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 13, 2013