NCT00196859

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,500

participants targeted

Target at P75+ for phase_3 breast-cancer

Timeline
Completed

Started Jun 2004

Typical duration for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

July 17, 2014

Status Verified

August 1, 2011

Enrollment Period

9.6 years

First QC Date

September 12, 2005

Last Update Submit

July 16, 2014

Conditions

Breast Cancer

Keywords

Early Breast Cancer in elderly PatientsIbandronate plus/minus Capecitabine in elderly patients

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (2)

A

ACTIVE COMPARATOR

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

Drug: Ibandronate

B

EXPERIMENTAL

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

Interventions

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

B
IbandronateDRUG

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

A

Eligibility Criteria

Age65 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof. Dr. med. Ulrike Nitz

Mönchengladbach, North Rhine-Westphalia, 41061, Germany

Location

Related Publications (2)

  • 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.

    PMID: 37797387DERIVED

  • 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.

    PMID: 34037241DERIVED

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Ibandronic AcidCapecitabine

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Ulrike Nitz, MD

    Evangelisches Krankenhaus Bethesda, Mönchengladbach

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

June 1, 2004

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

July 17, 2014

Record last verified: 2011-08

Locations

DE(1)