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

Phase 3
65 Years
Open (Enrolling)
Breast Cancer

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Trial Information

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

Title of the study:

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


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

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Ulrike Nitz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Evangelisches Krankenhaus Bethesda, Mönchengladbach


Germany: Federal Institute for Drugs and Medical Devices

Study ID:

GBG 32



Start Date:

June 2004

Completion Date:

August 2013

Related Keywords:

  • Breast Cancer
  • Early Breast Cancer in elderly Patients
  • Ibandronate plus/minus Capecitabine in elderly patients
  • Breast Neoplasms