At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 93 enrolled
Drug / intervention
IMC-A12 (cixutumumab) +5 morebiological
Likely dose
IMC-A12 (cixutumumab) 10 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2 Randomized, Multicenter Study of IMC-A12 as a Single Agent or in Combination With Antiestrogens in Postmenopausal Women With Hormone Receptor-Positive Advanced or Metastatic Breast Cancer After Progression on Antiestrogen Therapy
In Brief
A Phase 2 clinical trial evaluating IMC-A12 (cixutumumab), tamoxifen, and 4 other interventions for Metastatic Breast Cancer. Completed, enrolled 93 participants across 9 sites.
Detailed Summary
The purpose of this study is to determine whether IMC-A12 offers increased progression-free survival (PFS) associated with IMC-A12 monotherapy and IMC-A12 in combination with an antiestrogen therapy in patients with hormone receptor positive advanced or metastatic breast cancer that have experienced disease progression on antiestrogen therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetastatic Breast Cancer
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2008
First PostedAug 2008
Primary CompletionMar 2012
Study CompletionFeb 2015
TodayJul 2026
First PostedAug 6, 2008
Enrollment StartAug 1, 2008
Primary CompletionMar 1, 2012
Study CompletionFeb 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 17.9 years ago
Interventions
IMC-A12 (cixutumumab)biological
10 mg/kg I.V.
tamoxifendrug
Daily 20 mg, oral
Anastrozoledrug
Daily 1 mg, oral
Letrozoledrug
Daily 2.5 mg, oral
Exemestanedrug
Daily 25 mg, oral
Fulvestrantdrug
Monthly 250 mg, intramuscularly