NCT00128297

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
152

participants targeted

Target at P50-P75 for phase_4 breast-cancer

Timeline
Completed

Started Oct 2000

Typical duration for phase_4 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2000

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2004

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

August 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2005

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

3.6 years

First QC Date

August 8, 2005

Last Update Submit

March 27, 2023

Conditions

Breast CancerNeoplasm Metastasis

Keywords

Breast cancer patients with symptomatic bone metastases

Outcome Measures

Primary Outcomes (1)

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

    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

    18 months

Secondary Outcomes (3)

  • Number of skeletal events per treatment arm

    18 months

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

    18 months

  • Overall survival (OS)

    18 months

Study Arms (2)

Arm A: continuous administration

ACTIVE COMPARATOR

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

Drug: Pamidronate

Arm B: alternate administration

EXPERIMENTAL

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.

Drug: Pamidronate

Interventions

PamidronateDRUG
Also known as: Aredia
Arm A: continuous administrationArm B: alternate administration

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spanish Breast Cancer Research Group (GEICAM)

San Sebastián de los Reyes, Madrid, 28700, Spain

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Interventions

Pamidronate

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Study Director

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

    STUDY DIRECTOR

  • Study Director

    Hospital Clínico Universitario de Valencia

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2005

First Posted

August 9, 2005

Study Start

October 18, 2000

Primary Completion

June 4, 2004

Study Completion

June 4, 2004

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations

ES(1)