Study in Elderly Patients With Early Breast Cancer (ICE)

July 16, 2014 updated by: German Breast Group

Ibandronate With or Without Capecitabine in Elderly Patients With Early Breast Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

1500

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Nordrhein-Westfalen
      • Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
        • Prof. Dr. med. Ulrike Nitz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Any local or distant relapse of breast cancer, any second malignancy, and any death irrespective of its cause

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Breast Group

Collaborators

Hoffmann-La Roche
AstraZeneca

Investigators

  • Principal Investigator: Ulrike Nitz, MD, Evangelisches Krankenhaus Bethesda, Mönchengladbach

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2004

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

July 17, 2014

Last Update Submitted That Met QC Criteria

July 16, 2014

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GBG 32
  • BIG 4-04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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