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TerminatedNCT00770354Updated Aug 10, 2009

Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer

A Phase 2 interventional study of AS1402 and Letrozole in Breast Carcinoma, sponsored by Antisoma Research. Terminated at 2 sites in Russian Federation. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-08-10.

Sponsored by Antisoma Research · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
110
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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

02

Conditions studied

  • Breast Carcinoma

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Keywords

  • Breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 110 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Antisoma Research is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
110 participants (estimated)

Study arms

  • Experimental
    1

    AS1402 plus letrozole

    Drug: AS1402

  • Active comparator
    2

    Letrozole

    Drug: Letrozole

Interventions

  • DrugAS1402

    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).

    Also known as: huHMFG1

  • DrugLetrozole

    Daily 2.5 mg oral letrozole tablet

    Also known as: Femara

06

What researchers measure

Primary outcomes

  1. The primary efficacy endpoint is overall response rate (ORR)

    Time frame: Radiological evaluations are performed every 12 weeks up to progression

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: Radiological evaluations are performed every 12 weeks up to progression

  2. Time to progression (TTP)

    Time frame: Radiological evaluations are performed every 12 weeks up to progression

  3. Duration of overall response and duration of stable disease

    Time frame: Radiological evaluations are performed every 12 weeks up to progression

  4. Clinical benefit rate (CBR)

    Time frame: Radiological evaluations are performed every 12 weeks up to progression

  5. Safety and tolerability of AS1402 when combined with letrozole

    Time frame: Radiological evaluations are performed every 12 weeks up to progression

07

Study locations

2 sites
  • State Medical Institution
    Pyatigorsk, Stavropol 357500, Russian Federation
  • State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center
    Chelyabinsk, 454087, Russian Federation
08

References and documents

Publications

  • 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. PubMed 21878535 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 10, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00770354
Lead sponsor
Antisoma Research
First posted
Oct 10, 2008
Start date
Sep 2008
Primary completion
Aug 2010 (estimated)
Completion
Aug 2011 (estimated)
Last update
Aug 10, 2009

Study contacts

Gary Acton, MA MBBS MRCP
study director · Antisoma Research
Nuhad K Ibrahim, MD FACP
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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