Clinical trial NCT00128297: Pamidronate Administration in Breast Cancer Patients With Bone Metastases
Official title: Randomized, Multicentric Phase IV Clinical Trial for the Administration of Pamidronate in Breast Cancer Patients With Bone Metastases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Cancer
Neoplasm Metastasis
Keywords: Breast cancer patients with symptomatic bone metastases
Lead sponsor: Spanish Breast Cancer Research Group
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2005-08-09
Enrollment: 152
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Pamidronate efficacy to prevent first skeletal event: time until the appearance of the first skeletal event
timeFrame: 18 months
Secondary outcomes:
measure: Number of skeletal events per treatment arm
timeFrame: 18 months
measure: Quality of life: Short Form (SF)-36 questionnaire
timeFrame: 18 months
measure: Overall survival (OS)
timeFrame: 18 months
Other outcomes:
Locations:
city: San Sebastián de los Reyes
country: Spain
facility: Spanish Breast Cancer Research Group (GEICAM)
state: Madrid
Study officials:
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Study Director
role: STUDY_DIRECTOR
affiliation: Hospital Clínico Universitario de Valencia
name: Study Director
role: STUDY_DIRECTOR
References: