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AzTrials

Breast CancerPhase 3NCT00196859

Study in Elderly Patients With Early Breast Cancer (ICE)

A Phase 3 study testing Ibandronate, Capecitabine and Ibandronate in people with Breast Cancer, run by GBG Forschungs GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial is done to determine the role of adjuvant chemotherapy with capecitabine in patients ≥ 65. Read more about this study

Who is it for?
Ages 65 years and older, women only
Conditions the study is for
Breast Cancer
What is being tested?
Ibandronate, Capecitabine and Ibandronate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,500 participants
Where
1 siteGermany
Study dates
Jun 2004to Jan 2014
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • Women only
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Prof. Dr. med. Ulrike Nitz

    Mönchengladbach, North Rhine-Westphalia, 41061

Other trials in Germany

About this study

Official title: 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.

Read the 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

Conditions
Breast Cancer
Being tested
Ibandronate, Capecitabine, Ibandronate
Keywords
Early Breast Cancer in elderly Patients, Ibandronate plus/minus Capecitabine in elderly patients
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ibandronate, CapecitabineDrug

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

  • IbandronateDrug

    Ibandronate 50 mg p.o. daily or 6 mg i.v., q4W, 2yrs

Study groups in NCT00196859
Study groupRoleWhat they receive
AActive comparatorIbandronate 50 mg p.o. daily or 6 mg i.v., q4W, 2yrs
Receives: Drug: Ibandronate
BExperimentalIbandronate 50 mg p.o. daily or 6 mg i.v., q4W, 2yrs plus Capecitabine 2000 mg/m2 days 1-14 q d22 x6
Receives: Drug: Ibandronate, Capecitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

  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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Sep 2005 (estimated)
  2. Study startJun 2004
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00196859
Sponsor's protocol ID
GBG 32
Other IDs
BIG 4-04
Status last verified
Aug 2011
First submitted
12 Sep 2005
Last updated
17 Jul 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Schmidt M, Nitz U, Reimer T, Schmatloch S, Graf H, Just M, Stickeler E, Untch M, Runnebaum I, Belau A, Huober J, Jackisch C, Hofmann M, Krocker J, Nekljudova V, Loibl S; GBG/AGO-B, NOGGO/WSG study groups. Adjuvant capecitabine versus nihil in older patients with node-positive/high-risk node-negative early breast cancer receiving ibandronate - The ICE randomized clinical trial. Eur J Cancer. 2023 Nov;194:113324. doi: 10.1016/j.ejca.2023.113324. Epub 2023 Sep 7.

    PubMed 37797387

  • Hoon SN, Lau PK, White AM, Bulsara MK, Banks PD, Redfern AD. Capecitabine for hormone receptor-positive versus hormone receptor-negative breast cancer. Cochrane Database Syst Rev. 2021 May 26;5(5):CD011220. doi: 10.1002/14651858.CD011220.pub2.

    PubMed 34037241

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ibandronate, Capecitabine and Ibandronate in people with Breast Cancer, run by GBG Forschungs GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Any local or distant relapse of breast cancer, any second malignancy, and any death irrespective of its cause. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00196859, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2014.

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