NCT00193778

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
Last Updated

October 8, 2020

Status Verified

October 1, 2020

Enrollment Period

15.5 years

First QC Date

September 12, 2005

Last Update Submit

October 7, 2020

Conditions

Cancer of the Breast

Keywords

Metastatic breast cancerLocoregional treatmentSurvival

Outcome Measures

Primary Outcomes (2)

  • Overall survival

    Overall survival (OS) : Time interval between randomization and death

    3 years

  • Progression free survival

    PFS: Time interval between randomization and first date of progression of disease

    3 years

Secondary Outcomes (1)

  • Changes in VEGF, bFGF, Angiostatin and Endostatin

    5 years

Study Arms (2)

Loco Regional Treatment Arm (LRT)

EXPERIMENTAL

Surgery for breast cancer. (MRM/BCT)

Procedure: Surgery for breast cancer

No Loco-regional Treatment Arm

ACTIVE COMPARATOR

No surgery for Breast cancer

Other: No Loco-regional treatment

Interventions

Surgery for breast cancerPROCEDURE

This group will receive standard loco-regional treatment i.e. surgery (modified radical mastectomy (MRM)/ Simple SMAC/BCT) +/- radiotherapy

Loco Regional Treatment Arm (LRT)
No Loco-regional treatmentOTHER

This group will not receive any loco-regional treatment

No Loco-regional Treatment Arm

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tata Memorial Hospital

Mumbai, Maharashtra, 400 012, India

Location

Related Publications (9)

  • Lokich J. Spontaneous regression of metastatic renal cancer. Case report and literature review. Am J Clin Oncol. 1997 Aug;20(4):416-8. doi: 10.1097/00000421-199708000-00020.

    PMID: 9256902BACKGROUND

  • 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. doi: 10.1056/NEJMoa003013.

    PMID: 11759643BACKGROUND

  • 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. doi: 10.1016/s0140-6736(01)06103-7.

    PMID: 11583750BACKGROUND

  • 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.

    PMID: 2702641BACKGROUND

  • 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. doi: 10.1038/362841a0.

    PMID: 7683111BACKGROUND

  • 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.

    PMID: 1718597BACKGROUND

  • 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. doi: 10.1016/0092-8674(94)90200-3.

    PMID: 7525077BACKGROUND

  • 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. doi: 10.1101/sqb.1994.059.01.052. No abstract available.

    PMID: 7587101BACKGROUND

  • Badwe R, Hawaldar R, Nair N, Kaushik R, Parmar V, Siddique S, Budrukkar A, Mittra I, Gupta S. Locoregional treatment versus no treatment of the primary tumour in metastatic breast cancer: an open-label randomised controlled trial. Lancet Oncol. 2015 Oct;16(13):1380-8. doi: 10.1016/S1470-2045(15)00135-7. Epub 2015 Sep 9.

    PMID: 26363985DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Rajendra A Badwe, MS (Surgery)

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

February 1, 2005

Primary Completion

July 30, 2020

Study Completion

July 30, 2020

Last Updated

October 8, 2020

Record last verified: 2020-10

Locations

IN(1)