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Pamidronate Administration in Breast Cancer Patients With Bone Metastases

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by:
Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier:
NCT00128297
First received: August 8, 2005
Last updated: September 25, 2009
Last verified: September 2009
History of Changes
  Purpose

The study objective is to evaluate the differences, in terms of first occurrence of a skeletal event, in patients with breast cancer and symptomatic bone metastases, when pamidronate is administered during 2 years, or when it is administered during 6 months, followed by a six month rest period, and again a 6 month treatment period.


Condition Intervention Phase
Breast Cancer
Neoplasm Metastasis
 Drug: Pamidronate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Randomized, Multicentric Phase IV Clinical Trial for the Administration of Pamidronate in Breast Cancer Patients With Bone Metastases

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Spanish Breast Cancer Research Group:

Primary Outcome Measures:
  • Pamidronate efficacy to prevent first skeletal event

Secondary Outcome Measures:
  • Number of skeletal events per treatment arm
  • Quality of life per treatment arm
  • Overall survival

Estimated Enrollment: 120
Study Start Date: January 2001
Estimated Study Completion Date: December 2002
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent.
  • Up to two previous or current hormone therapy treatments for metastatic breast cancer are allowed.
  • Normal or borderline renal function (serum creatinine < 1.5 x upper normal limit [UNL]).
  • Normal calcium levels in serum, or slightly non-symptomatic high levels (< 1.25 x UNL).
  • Performance status 0, I or II in WHO scale.

Exclusion Criteria:

  • Treatment with bisphosphonates in the 30 previous days, or any time if the indication was treatment of metastatic bone lesions.
  • Treatment with bisphosphonates is only allowed if the indication is hypercalcaemia.
  • Metastases in central nervous system (CNS).
  • Hypersensitivity to bisphosphonates or other components of the formula.
  • Pregnant or lactating women.
  • Previous or current treatment with a second chemotherapy line or a third hormone therapy line for metastatic disease.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128297

Locations
Spain
Spanish Breast Cancer Research Group (GEICAM)
San Sebastián de los Reyes, Madrid, Spain, 28700
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Novartis
Investigators
Study Chair: Agustí Barnadas, MD., PhD. Hospital Santa Creu i Sant Pau
Study Chair: Ana Lluch, MD., PhD. University of Valencia
  More Information

Additional Information:
"Click here for more information about this study:"  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00128297     History of Changes
Other Study ID Numbers: GEICAM 2000-01
Study First Received: August 8, 2005
Last Updated: September 25, 2009
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Spanish Breast Cancer Research Group:
Breast cancer patients with symptomatic bone metastases

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Bone Neoplasms
Bone Marrow Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
 Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Pamidronate
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013