Clinical trial NCT00770354: Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Carcinoma
Keywords: Breast cancer
Lead sponsor: Antisoma Research
Sponsor class: INDUSTRY
First posted: 2008-10-10
Enrollment: 110
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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


Eligibility criteria: 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

Primary outcomes:
measure: The primary efficacy endpoint is overall response rate (ORR)
timeFrame: Radiological evaluations are performed every 12 weeks up to progression
Secondary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Radiological evaluations are performed every 12 weeks up to progression
measure: Time to progression (TTP)
timeFrame: Radiological evaluations are performed every 12 weeks up to progression
measure: Duration of overall response and duration of stable disease
timeFrame: Radiological evaluations are performed every 12 weeks up to progression
measure: Clinical benefit rate (CBR)
timeFrame: Radiological evaluations are performed every 12 weeks up to progression
measure: Safety and tolerability of AS1402 when combined with letrozole
timeFrame: Radiological evaluations are performed every 12 weeks up to progression
Other outcomes:
Locations:
city: Pyatigorsk
country: Russian Federation
facility: State Medical Institution
state: Stavropol
city: Chelyabinsk
country: Russian Federation
facility: State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center
Study officials:
affiliation: Antisoma Research
name: Gary Acton, MA MBBS MRCP
role: STUDY_DIRECTOR
affiliation: M.D. Anderson Cancer Center
name: Nuhad K Ibrahim, MD FACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.