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Ibandronate, Capecitabine

Phase 3

Breast Cancer | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jul 17, 2014

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment1,500

FDA Designations

No designations recorded

Clinical trial landscape

Ibandronate, Capecitabine · 1 trial · 1 indication

Phase 3 1
NCT00196859Study in Elderly Patients With Early Breast Cancer (ICE)Breast Cancer
COMPLETED1,500 Analytics
PHASE3COMPLETED
Study in Elderly Patients With Early Breast Cancer (ICE)
Breast CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

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

Interventions

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

Age Range65 Years to N/A
SexFEMALE
Healthy VolunteersNo
Study Sites1

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 ...

Countries:Germany
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