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Multicenter, Open-Label, Randomized Phase III Trial for Administration of Zoledronate to Breast Cancer Metastatic Patients With Non-Symptomatic Bone Lesions


Phase 3
18 Years
70 Years
Not Enrolling
Female
Breast Cancer, Neoplasm Metastasis

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Trial Information

Multicenter, Open-Label, Randomized Phase III Trial for Administration of Zoledronate to Breast Cancer Metastatic Patients With Non-Symptomatic Bone Lesions


Inclusion Criteria:



- Written informed consent.

- Age >= 18 years old.

- Metastatic breast cancer patients with lytic, sclerotic or mixed bone lesions.

- Non-symptomatic bone lesions, defined as pain absence, lack of bone complications
(fracture, hypercalcemia, central nervous system [CNS] compression), no need of
analgesic chronic administration for bone disease.

- A maximum of two chemotherapy lines for metastatic disease.

- A maximum of two hormone therapy lines for metastatic disease.

- Normal, minimally altered renal function (serum creatinine < 1.5 x upper normal limit
[UNL]).

- Normal serum calcium levels.

- Performance status 0,1 (World Health Organization [WHO]).

- Negative pregnancy test before study recruitment.

Exclusion Criteria:

- Previous treatment with bisphosphonates or raloxifene in the 30 days prior to
randomization.

- Metastasis in CNS.

- History of hypersensitivity to bisphosphonates.

- Pregnant or lactating women.

- Third chemotherapy line for metastatic disease.

- Third hormone therapy line for metastatic disease.

- Males.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to first bone metastases symptom

Principal Investigator

Agustí Barnadas, MD.,PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Spanish Breast Cancer Research Group (GEICAM)

Authority:

Spain: Spanish Agency of Medicines

Study ID:

GEICAM 2001-05

NCT ID:

NCT00130494

Start Date:

August 2002

Completion Date:

December 2006

Related Keywords:

  • Breast Cancer
  • Neoplasm Metastasis
  • Non-symptomatic bone metastases.
  • Breast Neoplasms
  • Neoplasms
  • Neoplasm Metastasis

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