Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer
NCT ID: NCT00770354
Last Updated: 2009-08-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
110 participants
INTERVENTIONAL
2008-09-30
2011-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
AS1402 plus letrozole
AS1402
A complete treatment cycle spans 28 days. Patients randomised to AS1402 will receive a 1-hour infusion of 9 mg/kg on day 1, 8, 15 and 22 of each cycle. Patients will receive letrozole (2.5 mg daily tablet).
2
Letrozole
Letrozole
Daily 2.5 mg oral letrozole tablet
Interventions
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AS1402
A complete treatment cycle spans 28 days. Patients randomised to AS1402 will receive a 1-hour infusion of 9 mg/kg on day 1, 8, 15 and 22 of each cycle. Patients will receive letrozole (2.5 mg daily tablet).
Letrozole
Daily 2.5 mg oral letrozole tablet
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Measurable disease according to the RECIST criteria
* Documented estrogen receptor-positive and/or progesterone receptor-positive tumour
* Postmenopausal women
Exclusion Criteria
* Relapse within 12 months after treatment discontinuation of an aromatase inhibitor in the adjuvant setting
* Unknown hormonal receptor status
* Known HER2/neu-positivity
18 Years
FEMALE
No
Sponsors
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Antisoma Research
INDUSTRY
Responsible Party
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Antisoma
Principal Investigators
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Gary Acton, MA MBBS MRCP
Role: STUDY_DIRECTOR
Antisoma Research
Nuhad K Ibrahim, MD FACP
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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State Medical Institution
Pyatigorsk, Stavropol Kray, Russia
State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center
Chelyabinsk, , Russia
Countries
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References
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Gorodetska I, Samusieva A, Lahuta T, Ponomarova O, Socha O, Kozeretska I. Exploring New Frontiers: Alternative Breast Cancer Treatments Through Glycocalyx Research. Breast J. 2025 May 22;2025:9952727. doi: 10.1155/tbj/9952727. eCollection 2025.
Ibrahim NK, Yariz KO, Bondarenko I, Manikhas A, Semiglazov V, Alyasova A, Komisarenko V, Shparyk Y, Murray JL, Jones D, Senderovich S, Chau A, Erlandsson F, Acton G, Pegram M. Randomized phase II trial of letrozole plus anti-MUC1 antibody AS1402 in hormone receptor-positive locally advanced or metastatic breast cancer. Clin Cancer Res. 2011 Nov 1;17(21):6822-30. doi: 10.1158/1078-0432.CCR-11-1151. Epub 2011 Aug 30.
Other Identifiers
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AS1402-C-201
Identifier Type: -
Identifier Source: org_study_id
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