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Pamidronate Administration in Breast Cancer Patients With Bone Metastases

This study has been completed.
Information provided by:
Spanish Breast Cancer Research Group Identifier:
First received: August 8, 2005
Last updated: September 25, 2009
Last verified: September 2009
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
Intervention Model: Parallel Assignment
Masking: None (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:

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00128297

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

Additional Information: Identifier: NCT00128297     History of Changes
Other Study ID Numbers: GEICAM 2000-01
Study First Received: August 8, 2005
Last Updated: September 25, 2009

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes processed this record on August 17, 2017