Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128297
Status:
COMPLETED
Last Update Posted:
2023-03-28
First Post:
2005-08-08
Brief Title:
Pamidronate Administration in Breast Cancer Patients With Bone Metastases
Sponsor:
Spanish Breast Cancer Research Group
Organization:
Spanish Breast Cancer Research Group
Study Overview
Official Title:
Randomized Multicentric Phase IV Clinical Trial for the Administration of Pamidronate in Breast Cancer Patients With Bone Metastases
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None