Pamidronate Administration in Breast Cancer Patients With Bone Metastases

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: NCT00128297
Recruitment Status : Completed
First Posted : August 9, 2005
Last Update Posted : September 28, 2009
Information provided by:
Spanish Breast Cancer Research Group

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Neoplasm Metastasis Drug: Pamidronate Phase 4

Study Type : Interventional  (Clinical Trial)
Enrollment : 120 participants
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
Study Start Date : January 2001
Study Completion Date : December 2002

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Pamidronate efficacy to prevent first skeletal event

Secondary Outcome Measures :
  1. Number of skeletal events per treatment arm
  2. Quality of life per treatment arm
  3. Overall survival

Information from the National Library of Medicine

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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.

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): 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

Additional Information: Identifier: NCT00128297     History of Changes
Other Study ID Numbers: GEICAM 2000-01
First Posted: August 9, 2005    Key Record Dates
Last Update Posted: September 28, 2009
Last Verified: September 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