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

Primary Purpose

Breast Cancer, Neoplasm Metastasis

Status
Terminated
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Zoledronic acid
Sponsored by
Spanish Breast Cancer Research Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Non-symptomatic bone metastases.

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Spanish Breast Cancer Research Group (GEICAM)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Arm A: Zoledronic acid 4 mg

Arm B: Observation

Arm Description

Zoledronate 4 mg every 3 or 4 weeks. This arm will receive study treatment from the time of entry into the trial, until the appearance of the symptoms of bone metastases (or a maximum period of 12 months, whichever occurs first).

Patients will not receive any treatment with bisphosphonates until the time of onset of symptoms (or a maximum period of 12 months, whichever occurs sooner).

Outcomes

Primary Outcome Measures

Time to first bone metastases
The main variable of evaluation is the time until the appearance of first bone metastases.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 12, 2005
Last Updated
April 11, 2019
Sponsor
Spanish Breast Cancer Research Group
Collaborators
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00130494
Brief Title
Zoledronic Acid Administration to Metastatic Breast Cancer Patients With Non-symptomatic Bone Lesions
Official Title
Multicenter, Open-label, Randomized Phase III Trial for Administration of Zoledronate to Breast Cancer Metastatic Patients With Non-symptomatic Bone Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment
Study Start Date
August 29, 2002 (Actual)
Primary Completion Date
November 20, 2006 (Actual)
Study Completion Date
October 22, 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spanish Breast Cancer Research Group
Collaborators
Novartis

4. Oversight

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Neoplasm Metastasis
Keywords
Non-symptomatic bone metastases.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A: Zoledronic acid 4 mg
Arm Type
Experimental
Arm Description
Zoledronate 4 mg every 3 or 4 weeks. This arm will receive study treatment from the time of entry into the trial, until the appearance of the symptoms of bone metastases (or a maximum period of 12 months, whichever occurs first).
Arm Title
Arm B: Observation
Arm Type
No Intervention
Arm Description
Patients will not receive any treatment with bisphosphonates until the time of onset of symptoms (or a maximum period of 12 months, whichever occurs sooner).
Intervention Type
Drug
Intervention Name(s)
Zoledronic acid
Other Intervention Name(s)
Zometa
Primary Outcome Measure Information:
Title
Time to first bone metastases
Description
The main variable of evaluation is the time until the appearance of first bone metastases.
Time Frame
Up to disease progression
Secondary Outcome Measure Information:
Title
Quality of life per treatment arm
Description
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.
Time Frame
Up to disease progression
Title
The Number of Participants Who Experienced Adverse Events (AE)
Description
Safety will be assessed by standard clinical and laboratory tests. Adverse events grade will be defined by the NCI CTCAE.
Time Frame
Through study treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Hospital Clínico Universitario de Valencia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Hospital Santa Creu i Sant Pau
Official's Role
Study Director
Facility Information:
Facility Name
Spanish Breast Cancer Research Group (GEICAM)
City
San Sebastián de los Reyes
State/Province
Madrid
ZIP/Postal Code
28700
Country
Spain

12. IPD Sharing Statement

Links:
URL
http://www.geicam.org
Description
Click here for more information about this study: GEICAM 2001-05

Learn more about this trial

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

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