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The aim of this study is to compare the overall tumour response rate per RECIST in postmenopausal women with metastatic or locally advanced breast cancer receiving AS1402 in combination with letrozole compared to letrozole alone
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | AS1402 plus letrozole |
|
| 2 | Active Comparator | Letrozole |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AS1402 | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is overall response rate (ORR) | Radiological evaluations are performed every 12 weeks up to progression |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Radiological evaluations are performed every 12 weeks up to progression | |
| Time to progression (TTP) | Radiological evaluations are performed every 12 weeks up to progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Acton, MA MBBS MRCP | Antisoma Research | Study Director |
| Nuhad K Ibrahim, MD FACP | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Medical Institution | Pyatigorsk | Stavropol Kray | 357500 | Russia | ||
| State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40443562 | Derived | 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. | |
| 21878535 | Derived | 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. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C547393 | epitumomab |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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|
| Letrozole | Drug | Daily 2.5 mg oral letrozole tablet |
|
|
| Duration of overall response and duration of stable disease | Radiological evaluations are performed every 12 weeks up to progression |
| Clinical benefit rate (CBR) | Radiological evaluations are performed every 12 weeks up to progression |
| Safety and tolerability of AS1402 when combined with letrozole | Radiological evaluations are performed every 12 weeks up to progression |
| Chelyabinsk |
| 454087 |
| Russia |
| D017437 |
| Skin and Connective Tissue Diseases |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |