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Study in Elderly Patients With Early Breast Cancer (ICE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00196859
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : July 17, 2014
Hoffmann-La Roche
Information provided by (Responsible Party):
German Breast Group

Brief Summary:
This trial is done to determine the role of adjuvant chemotherapy with capecitabine in patients ≥ 65.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Ibandronate, Capecitabine Drug: Ibandronate Phase 3

Detailed Description:

Title of the study:

Ibandronate with or without Capecitabine in Elderly Patients with Early Breast Cancer - (ICE Study)


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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Ibandronate With or Without Capecitabine in Elderly Patients With Early Breast Cancer
Study Start Date : June 2004
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: A
Ibandronate 50 mg p.o. daily or 6 mg i.v., q4W, 2yrs
Drug: Ibandronate
Ibandronate 50 mg p.o. daily or 6 mg i.v., q4W, 2yrs

Experimental: B
Ibandronate 50 mg p.o. daily or 6 mg i.v., q4W, 2yrs plus Capecitabine 2000 mg/m2 days 1-14 q d22 x6
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

Primary Outcome Measures :
  1. Any local or distant relapse of breast cancer, any second malignancy, and any death irrespective of its cause

Secondary Outcome Measures :
  1. Any death related and not-related to breast cancer
  2. Any premature treatment discontinuation of capecitabine or ibandronate
  3. Any grade II to grade IV AE specified to serious or non serious events
  4. Every bone fracture, bone surgery, new diagnosis of osteoporosis
  5. Completed months of i.v. or p.o. treatment with ibandronate
  6. Frequency of changes of preference of Ibandronate application
  7. Evaluation according to EORTC Q 30

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements.
  2. Histologically confirmed unilateral or bilateral primary carcinoma of the breast.
  3. Age at diagnosis ≥ 65 years
  4. Adequately surgical treatment with complete resection (Ro) of the tumor and > or = 10 axillary nodes. Sole sentinel node biopsy is allowed if the sentinel node shows no tumor involvement.
  5. Node positive disease irrespective of additional risk factors or node negative disease with at least one other risk factor (histologic tumor size > or = 2 cm, grade II or III, ER and PR negative)
  6. No evidence for distant metastasis after complete diagnostic work up
  7. Performance Status ECOG < or = 2
  8. Charlson Scale of < or = 2
  9. Estimated life expectancy of at least 5 years (irrespective of breast cancer diagnosis)
  10. The patient must be accessible for treatment and follow-up.

Exclusion Criteria:

  1. Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
  2. Inadequate organ function including: Leucocytes < 3,5 G/l, Platelets < 100 G/l , Bilirubin 1.25 times above normal limits, Creatinine clearance calculated by the Cockroft-Gold formula of above 50 ml/min, uncompensated cardiac function, severe and relevant co-morbidity that would interact with the application of cytotoxic agents or the participation in the study
  3. Another primary malignancy with an event-free survival of < 5 years, except curatively treated basalioma of the skin
  4. Time since axillary dissection > 3 months
  5. Locally advanced, non-operable breast cancer
  6. Previous invasive breast carcinoma
  7. Previous treatment with cytotoxic agents for any reason
  8. Concurrent treatment with hormonal replacement therapy (treatment should be stopped before entering the trial).
  9. Previous treatment with bisphosphonates for osteoporosis is allowed, however this treatment has to be substituted by the trial medication
  10. Concurrent specific systemic anti-tumor treatment or treatment with experimental compounds within the last 6 months
  11. Concurrent treatment with other tumor specific experimental drugs. Participation in another clinical trial with any investigational not marketed drug within 30 days prior to study entry.
  12. Concurrent treatment with virostatic agents like brivudine or analoga sorivudine, concurrent treatment with aminoglycosides
  13. Male patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00196859

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Prof. Dr. med. Ulrike Nitz
Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
Sponsors and Collaborators
German Breast Group
Hoffmann-La Roche
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Principal Investigator: Ulrike Nitz, MD Evangelisches Krankenhaus Bethesda, Mönchengladbach
Additional Information:
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Responsible Party: German Breast Group Identifier: NCT00196859    
Other Study ID Numbers: GBG 32
BIG 4-04
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: July 17, 2014
Last Verified: August 2011
Keywords provided by German Breast Group:
Early Breast Cancer in elderly Patients
Ibandronate plus/minus Capecitabine in elderly patients
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Ibandronic Acid
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Bone Density Conservation Agents
Physiological Effects of Drugs