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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00193778
Recruitment Status : Active, not recruiting
First Posted : September 19, 2005
Last Update Posted : January 17, 2018
Information provided by (Responsible Party):
Dr Rajendra A. Badwe, Tata Memorial Centre

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.

Condition or disease Intervention/treatment Phase
Cancer of the Breast Procedure: Surgery for breast cancer Other: No Loco-regional treatment Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2005
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 3 years ]
    Overall survival (OS) : Time interval between randomization and death

  2. Progression free survival [ Time Frame: 3 years ]
    PFS: Time interval between randomization and first date of progression of disease

Secondary Outcome Measures :
  1. Changes in VEGF, bFGF, Angiostatin and Endostatin [ Time Frame: 5 years ]
    The secondary endpoints include the assess of loco-regional treatment on levels

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  1. Patients who are not fit to receive anthracycline based chemotherapy.
  2. More than two visceral organ involvement.
  3. Multiple liver metastases with deranged liver function tests (SGOT/SGPT more than four times the upper normal limit).
  4. Locally static or progressive disease or systemically progressive disease as shown by repeat staging investigations guided by worsening symptoms.
  5. Ulceration/ fungation/ bleeding after completion of chemotherapy, which mandates surgery.
  6. Expected survival of less than six months after completion of chemotherapy.
  7. Unfit for anaesthesia due to metastatic disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00193778

Tata Memorial Hospital
Mumbai, Maharashtra, India, 400 012
Sponsors and Collaborators
Tata Memorial Hospital
Principal Investigator: Rajendra A Badwe, MS (Surgery) Tata Memorial Hospital, Ernest Borges Road, Parel, Mumbai 400 012


Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr Rajendra A. Badwe, Director, Tata Memorial Centre Identifier: NCT00193778     History of Changes
Other Study ID Numbers: TMH/153/2004
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: October 2016

Keywords provided by Dr Rajendra A. Badwe, Tata Memorial Centre:
Metastatic breast cancer
Locoregional treatment

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases