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Completed

NCT Number: NCT00128297

Pamidronate Administration in Breast Cancer Patients With Bone Metastases

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Spanish Breast Cancer Research Group (GEICAM)

San Sebastián de los Reyes, Madrid, 28700, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pamidronate

Drug

Other names: Aredia

Primary outcomes

  1. Pamidronate efficacy to prevent first skeletal event: time until the appearance of the first skeletal event

    Time frame: 18 months

    The main variable of evaluation is the time until the appearance of the first skeletal event. Skeletal event is defined as pathological bone fracture, or spine cord compression, or radiation bone treatment, or tumour induced hypercalcemia

Secondary outcomes

  1. Number of skeletal events per treatment arm

    Time frame: 18 months

    The main variable of evaluation is the time until the appearance of the first skeletal event per arm.

  2. Quality of life: Short Form (SF)-36 questionnaire

    Time frame: 18 months

    Quality of Life (QoL) was measured with Short Form (SF)-36 questionnaire, which is a 36 item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score, the more disability, and the higher the score the less disability (a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability). The eight sections are vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health. It will be completed since baseline visit and during all treatment period delivered to the patient before the start of each visit.

  3. Overall survival (OS)

    Time frame: 18 months

    OS will be determined from the date of randomization until the date of death for any reason.

Sponsors and collaborators

Lead sponsor

Spanish Breast Cancer Research Group

Other

Collaborators

  • Novartis

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2004
Study completion
2004
First posted
Aug 9, 2005
Registry last updated
Mar 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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