Clinical trial · Interventional
Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer
A Phase II, Randomised, Open-Label, Multicentre Study of AS1402 in Combination With Letrozole as First Line Treatment in Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer
NCT00770354CI-TRIAL-00002529terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AS1402 | Drug | — | UNRESOLVED |
| Letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- AS1402 plus letrozole
- interventionNames
- Drug: AS1402
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Letrozole
- interventionNames
- Drug: Letrozole
Primary outcomes (1)
- measure
- The primary efficacy endpoint is overall response rate (ORR)
- timeFrame
- Radiological evaluations are performed every 12 weeks up to progression
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed locally advanced or metastatic breast cancer not amenable to curative therapy * Measurable disease according to the RECIST criteria * Documented estrogen receptor-positive and/or progesterone receptor-positive tumour * Postmenopausal women Exclusion Criteria: * Prior chemotherapy and/or endocrine therapy for advanced breast disease * Relapse within 12 months after treatment discontinuation of an aromatase inhibitor in the adjuvant setting * Unknown hormonal receptor status * Known HER2/neu-positivity
References
Publications (2)
- DERIVEDGorodetska 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. PMID 40443562
- DERIVEDIbrahim 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. PMID 21878535