Pamidronate Administration in Breast Cancer Patients With Bone Metastases

NCT ID: NCT00128297

Last Updated: 2023-03-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 152 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-10-18
• Study Completion Date: 2004-06-04

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.

Detailed Description

Background: Pamidronate (PMT) is effective in reducing skeletal related events (SRE) in breast cancer (BC) patients with bone metastasis (BM). Its best way of administration and optimum treatment duration are still to be determined.

Objective: evaluate the efficacy of continuous administration (arm A) vs. alternate administration (arm B) of PMT to delay time to first SRE in BC pt presenting with symptomatic BM.

Methods: patients aged >18, Eastern Cooperative Oncology Group (ECOG) performance status ≥ 2, adequate renal function, and BC symptomatic BM were eligible. BM was defined as presence of 3 or more hot spots (HS) in skeletal scintigraphy (SS), or any number of HS in SS if osteolytic, osteoblastic or mixed bone lesions determined by radiography, or 2 or less HS in SS if magnetic resonance or CT scan confirmation of BM. Symptomatic BM was defined as pain associated to SS HS, or SRE (pathological fractures or spine cord compression or radiation bone treatment or tumour induced hypercalcemia), or treatment with analgesia due to bone pain. Patients were allowed up to 1 previous chemotherapy and 2 previous hormone therapy lines for metastatic disease. Antineoplastic therapy could be changed at any time during the study. Eligible patients were stratified (isolated bone metastasis or associated to node or skin lesions vs. bone metastasis associated to visceral disease) and randomized to receive 2 hour-iv. PMT 90 mg every 3-4 weeks for 18 months (arm A) or iv. PMT 90 mg every 3-4 weeks for 6 months, followed by a 6 months rest, and a new 6 months on-treatment period (arm B). Quality of Life (QoL) was measured with short form (SF)-36 questionnaire.

Conditions

Breast Cancer; Neoplasm Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Arm A: continuous administration

Pamidronate 90 mg/m2 iv every 3-4 weeks, during 18 months

Group Type: ACTIVE_COMPARATOR

Pamidronate

Intervention Type: DRUG

Arm B: alternate administration

Pamidronate 90 mg/m2 iv every 3-4 weeks, during 6 months, followed by a 6 month rest, and a new 6 months treatment period.

Group Type: EXPERIMENTAL

Pamidronate

Intervention Type: DRUG

Interventions

Pamidronate

Intervention Type: DRUG

Other Intervention Names

Aredia

Eligibility Criteria

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 World Health Organization (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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: collaborator

Spanish Breast Cancer Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Director

Role: STUDY_DIRECTOR

Hospital Clínico Universitario de Valencia

Locations

Spanish Breast Cancer Research Group (GEICAM)

San Sebastián de los Reyes, Madrid, Spain

Countries

Spain

Related Links

http://www.geicam.org

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Other Identifiers

GEICAM 2000-01

Identifier Type: -

Identifier Source: org_study_id