Study in Elderly Patients With Early Breast Cancer (ICE)

This study has been completed.
Sponsor:
Collaborators:
Hoffmann-La Roche
AstraZeneca
Information provided by (Responsible Party):
German Breast Group
ClinicalTrials.gov Identifier:
NCT00196859
First received: September 12, 2005
Last updated: July 16, 2014
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Breast Cancer
Drug: Ibandronate, Capecitabine
Drug: Ibandronate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ibandronate With or Without Capecitabine in Elderly Patients With Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by German Breast Group:

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

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

Estimated Enrollment: 1500
Study Start Date: June 2004
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00196859

Locations
Germany
Prof. Dr. med. Ulrike Nitz
Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
Sponsors and Collaborators
German Breast Group
Hoffmann-La Roche
AstraZeneca
Investigators
Principal Investigator: Ulrike Nitz, MD Evangelisches Krankenhaus Bethesda, Mönchengladbach
  More Information

Additional Information:
No publications provided

Responsible Party: German Breast Group
ClinicalTrials.gov Identifier: NCT00196859     History of Changes
Other Study ID Numbers: GBG 32, BIG 4-04
Study First Received: September 12, 2005
Last Updated: July 16, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by German Breast Group:
Early Breast Cancer in elderly Patients
Ibandronate plus/minus Capecitabine in elderly patients

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Ibandronic acid
Diphosphonates
Capecitabine
Fluorouracil
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on August 19, 2014