Ignite Creation Date:
2025-12-24 @ 2:59 PM
Ignite Modification Date:
2025-12-29 @ 1:28 PM
Study NCT ID:
NCT00196859
Status:
COMPLETED
Last Update Posted:
2014-07-17
First Post:
2005-09-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study in Elderly Patients With Early Breast Cancer (ICE)
Sponsor:
GBG Forschungs GmbH
Organization:
Study Overview
Official Title:
Ibandronate With or Without Capecitabine in Elderly Patients With Early Breast Cancer
Status:
COMPLETED
Status Verified Date:
2011-08
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:
This trial is done to determine the role of adjuvant chemotherapy with capecitabine in patients ≥ 65.
Detailed Description:
Title of the study:
Ibandronate with or without Capecitabine in Elderly Patients with Early Breast Cancer - (ICE Study)
Rationale:
Approximately 50% of new diagnosis of early breast cancer is made in patients above the age of 65. As this age group has not been eligible for most trials in the past, the effect of adjuvant therapy is still unclear in elderly patients. The primary aim of this trial will be to determine the role of adjuvant chemotherapy with capecitabine in elderly patients. The high activity, acceptable toxicity and oral formulation of this compound especially meet the requirements of elderly patients.
Bisphosphonates are of established effectivity in treatment and prevention of osteoporosis. Furthermore, two studies have recently shown that adjuvant long term use of clodronate can reduce the risk of recurrence of breast cancer. The third generation bisphosphonate ibandronate will be given in this trial to all patients to prevent osteoporosis and recurrence from breast cancer, both conditions these patients are at risk. As the preference of elderly patients for intravenous or oral application is not known, the mode of application of ibandronate will be according to patients' choice and the preference and compliance will be a secondary endpoint.
Primary objective
To compare the event-free survival in elderly patients after local treatment for primary breast cancer treated with either ibandronate alone or ibandronate and capecitabine as adjuvant treatment
Secondary objectives
To compare the overall survival between the two arms
To determine the compliance in both arms
To determine the toxicity in both arms
To determine the rate of bone-related events in hormone sensitive and insensitive disease (with or without endocrine therapy)
To determine the preference to oral or intravenous application of ibandronate
To assess quality of life
To compare a geriatric assessment by Charlson versus VES 13 score
Tertiary objective
To determine prognostic factors on tumor tissue collected from primary surgery and to correlate them with study treatment effect
To evaluate the prognostic impact of age, serum albumin, hemoglobin level, creatinine clearance, Charlson Score, VES-Score in a multivariate analysis for the prediction of treatment associated adverse events and limited life time expectancy
Ibandronate with or without Capecitabine in Elderly Patients with Early Breast Cancer - (ICE Study)
Rationale:
Approximately 50% of new diagnosis of early breast cancer is made in patients above the age of 65. As this age group has not been eligible for most trials in the past, the effect of adjuvant therapy is still unclear in elderly patients. The primary aim of this trial will be to determine the role of adjuvant chemotherapy with capecitabine in elderly patients. The high activity, acceptable toxicity and oral formulation of this compound especially meet the requirements of elderly patients.
Bisphosphonates are of established effectivity in treatment and prevention of osteoporosis. Furthermore, two studies have recently shown that adjuvant long term use of clodronate can reduce the risk of recurrence of breast cancer. The third generation bisphosphonate ibandronate will be given in this trial to all patients to prevent osteoporosis and recurrence from breast cancer, both conditions these patients are at risk. As the preference of elderly patients for intravenous or oral application is not known, the mode of application of ibandronate will be according to patients' choice and the preference and compliance will be a secondary endpoint.
Primary objective
To compare the event-free survival in elderly patients after local treatment for primary breast cancer treated with either ibandronate alone or ibandronate and capecitabine as adjuvant treatment
Secondary objectives
To compare the overall survival between the two arms
To determine the compliance in both arms
To determine the toxicity in both arms
To determine the rate of bone-related events in hormone sensitive and insensitive disease (with or without endocrine therapy)
To determine the preference to oral or intravenous application of ibandronate
To assess quality of life
To compare a geriatric assessment by Charlson versus VES 13 score
Tertiary objective
To determine prognostic factors on tumor tissue collected from primary surgery and to correlate them with study treatment effect
To evaluate the prognostic impact of age, serum albumin, hemoglobin level, creatinine clearance, Charlson Score, VES-Score in a multivariate analysis for the prediction of treatment associated adverse events and limited life time expectancy
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| BIG 4-04 | None | None | View |