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Randomized, Multicentric Phase IV Clinical Trial for the Administration of Pamidronate in Breast Cancer Patients With Bone Metastases


Phase 4
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Neoplasm Metastasis

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Trial Information

Randomized, Multicentric Phase IV Clinical Trial for the Administration of Pamidronate in Breast Cancer Patients With Bone Metastases


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Pamidronate efficacy to prevent first skeletal event

Principal Investigator

Agustí Barnadas, MD., PhD.

Investigator Role:

Study Chair

Investigator Affiliation:

Hospital Santa Creu i Sant Pau

Authority:

Spain: Spanish Agency of Medicines

Study ID:

GEICAM 2000-01

NCT ID:

NCT00128297

Start Date:

January 2001

Completion Date:

December 2002

Related Keywords:

  • Breast Cancer
  • Neoplasm Metastasis
  • Breast cancer patients with symptomatic bone metastases
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Bone Neoplasms
  • Bone Marrow Diseases

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