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Sponsors and Collaborators: |
German Breast Group Hoffmann-La Roche AstraZeneca |
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Information provided by: | German Breast Group |
ClinicalTrials.gov Identifier: | NCT00196859 |
This trial is done to determine the role of adjuvant chemotherapy with capecitabine in patients ≥ 65.
Condition | Intervention | Phase |
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Breast Cancer |
Drug: Ibandronate, Capecitabine Drug: Ibandronate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Ibandronate With or Without Capecitabine in Elderly Patients With Early Breast Cancer |
Estimated Enrollment: | 1500 |
Study Start Date: | June 2004 |
Estimated Study Completion Date: | October 2010 |
Arms | Assigned Interventions |
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A: Active Comparator
Ibandronate 50 mg p.o. daily or 6 mg i.v., q4W, 2yrs
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Drug: Ibandronate
Ibandronate 50 mg p.o. daily or 6 mg i.v., q4W, 2yrs
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B: Experimental
Ibandronate 50 mg p.o. daily or 6 mg i.v., q4W, 2yrs plus Capecitabine 2000 mg/m2 days 1-14 q d22 x6
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Drug: Ibandronate, Capecitabine
Ibandronate 50 mg p.o. daily or 6 mg i.v., q4W, 2yrs plus Capecitabine 2000 mg/m2 days 1-14 q d22 x6
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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
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Horst Mochnatzki | +49 (0)6102-7408 ext 427 | ice@germanbreastgroup.de |
Contact: Birgit Raasch | +49 (0)6102-7408 ext 438 | ice@germanbreastgroup.de |
Germany, Nordrhein-Westfalen | |
Prof. Dr. med. Ulrike Nitz | Recruiting |
Mönchengladbach, Nordrhein-Westfalen, Germany, 41061 | |
Contact: Ulrike Nitz, MD +49 (0)2161-981 ext 2330 ulrike.nitz@wsg-online.com | |
Contact: Frank Werner, PHD +49 (0)2161-566 ext 2314 frank.werner@wsg-online.com |
Principal Investigator: | Ulrike Nitz, MD | Evangelisches Krankenhaus Bethesda, Mönchengladbach |
Responsible Party: | GBG Forschungs GmbH ( Prof. Dr. med. Gunter von Minckwitz ) |
Study ID Numbers: | GBG32, BIG 4-04 |
Study First Received: | September 12, 2005 |
Last Updated: | May 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00196859 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Early Breast Cancer in elderly Patients Ibandronate plus/minus Capecitabine in elderly patients |
Antimetabolites Capecitabine Ibandronic acid Skin Diseases |
Breast Neoplasms Bone Density Conservation Agents Breast Diseases |
Antimetabolites Capecitabine Antimetabolites, Antineoplastic Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Breast Neoplasms |
Bone Density Conservation Agents Pharmacologic Actions Neoplasms Neoplasms by Site Ibandronic acid Therapeutic Uses Breast Diseases |