Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00130494
• Other study ID #: GEICAM 2001-05
• Status: Terminated
• Phase: Phase 3
• Start date: August 29, 2002
• Est. completion date: October 22, 2007

Study information

• Verified date: April 2019
• Source: Spanish Breast Cancer Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, randomized, multicenter phase III trial to assess the efficacy of early administration of zoledronate versus observation in delaying bone-related symptoms in metastatic breast cancer patients.

Description:

Patients will be randomised to receive 4 mg zoledronate every 3-4 weeks versus observation until bone-related symptoms appear, or up to 12 months. One hundred twelve patients per treatment arm will be enrolled in the study.

Once bone-related symptoms appear, study participation is over. During the study, the following will be assessed:

• quality of life,

• performance status,

• pain rating,

• analgesic administration and

• adverse events The principal objective is the delay in bone-related symptoms in those patients with early zoledronate administration.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 97
• Est. completion date: October 22, 2007
• Est. primary completion date: November 20, 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• Zoledronic acid

Locations

Country	Name	City	State
Spain	Spanish Breast Cancer Research Group (GEICAM)	San Sebastián de los Reyes	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Spanish Breast Cancer Research Group	Novartis

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to first bone metastases	The main variable of evaluation is the time until the appearance of first bone metastases.	Up to disease progression
Secondary	Quality of life per treatment arm	Quality of Life (QoL) will be measured with Short Form (SF)-36 questionnaire and Short questionnaire for the evaluation of pain since baseline visit and during all treatment period delivered to the patient before the start of each visit.	Up to disease progression
Secondary	The Number of Participants Who Experienced Adverse Events (AE)	Safety will be assessed by standard clinical and laboratory tests. Adverse events grade will be defined by the NCI CTCAE.	Through study treatment

External Links

•   Click here for more information about this study: GEICAM 2001-05