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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00193778
First Posted: September 19, 2005
Last Update Posted: October 19, 2016
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.
Information provided by (Responsible Party):
Dr Rajendra A. Badwe, Tata Memorial Centre
  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
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

Resource links provided by NLM:


Further study details as provided by Dr Rajendra A. Badwe, Tata Memorial Centre:

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

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


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


Enrollment: 350
Study Start Date: February 2005
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (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

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult)
Sexes 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:

  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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00193778


Locations
India
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400 012
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:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Rajendra A. Badwe, Director, Tata Memorial Centre
ClinicalTrials.gov Identifier: NCT00193778     History of Changes
Other Study ID Numbers: TMH/153/2004
First Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: October 19, 2016
Last Verified: October 2016

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

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