Status:
COMPLETED
Study in Elderly Patients With Early Breast Cancer (ICE)
Lead Sponsor:
GBG Forschungs GmbH
Collaborating Sponsors:
Hoffmann-La Roche
AstraZeneca
Conditions:
Breast Cancer
Eligibility:
FEMALE
65+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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.
- Histologically confirmed unilateral or bilateral primary carcinoma of the breast.
- Age at diagnosis ≥ 65 years
- 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.
- 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)
- No evidence for distant metastasis after complete diagnostic work up
- Performance Status ECOG \< or = 2
- Charlson Scale of \< or = 2
- Estimated life expectancy of at least 5 years (irrespective of breast cancer diagnosis)
- The patient must be accessible for treatment and follow-up.
Exclusion
- Known hypersensitivity reaction to the compounds or incorporated substances or known dihydropyrimidine dehydrogenase deficiency.
- 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
- Another primary malignancy with an event-free survival of \< 5 years, except curatively treated basalioma of the skin
- Time since axillary dissection \> 3 months
- Locally advanced, non-operable breast cancer
- Previous invasive breast carcinoma
- Previous treatment with cytotoxic agents for any reason
- Concurrent treatment with hormonal replacement therapy (treatment should be stopped before entering the trial).
- Previous treatment with bisphosphonates for osteoporosis is allowed, however this treatment has to be substituted by the trial medication
- Concurrent specific systemic anti-tumor treatment or treatment with experimental compounds within the last 6 months
- 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.
- Concurrent treatment with virostatic agents like brivudine or analoga sorivudine, concurrent treatment with aminoglycosides
- Male patients
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2014
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT00196859
Start Date
June 1 2004
End Date
January 1 2014
Last Update
July 17 2014
Active Locations (1)
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1
Prof. Dr. med. Ulrike Nitz
Mönchengladbach, North Rhine-Westphalia, Germany, 41061