Breast CarcinomaPhase 2NCT00770354
Phase II Study of AS1402 Combined With Letrozole to Treat Breast Cancer
A Phase 2 study testing AS1402 and Letrozole in people with Breast Carcinoma, run by Antisoma Research at 2 sites in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- AS1402 and Letrozole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesRussia
- Study dates
- Sep 2008to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Russia2 sites
State Therapeutical and Prophylactic Institution: Chelyabinsk Regional Oncological Center
Chelyabinsk, 454087
State Medical Institution
Pyatigorsk, Stavropol Kray, 357500
About this study
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
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
- Breast Carcinoma
- Being tested
- AS1402, Letrozole
- Keywords
- Breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AS1402Drug
Also called huHMFG1
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).
LetrozoleDrug
Also called Femara
Daily 2.5 mg oral letrozole tablet
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | AS1402 plus letrozole Receives: Drug: AS1402 |
| 2 | Active comparator | Letrozole Receives: Drug: Letrozole |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy endpoint is overall response rate (ORR)
Measured: Radiological evaluations are performed every 12 weeks up to progression
Secondary outcomes (5)
Progression-free survival (PFS)
Measured: Radiological evaluations are performed every 12 weeks up to progression
Time to progression (TTP)
Measured: Radiological evaluations are performed every 12 weeks up to progression
Duration of overall response and duration of stable disease
Measured: Radiological evaluations are performed every 12 weeks up to progression
Clinical benefit rate (CBR)
Measured: Radiological evaluations are performed every 12 weeks up to progression
Safety and tolerability of AS1402 when combined with letrozole
Measured: Radiological evaluations are performed every 12 weeks up to progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2008 (estimated)
- Study startSep 2008
- Primary completionAug 2010 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antisoma Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gary Acton, MA MBBS MRCP, Study director, Antisoma ResearchNuhad K Ibrahim, MD FACP, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00770354
- Sponsor's protocol ID
- AS1402-C-201
- Status last verified
- Aug 2009
- First submitted
- 9 Oct 2008
- Last updated
- 10 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 40443562Ibrahim 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00770354
- Acronym / sponsor ID
- AS1402-C-201
- Conditions
- Breast Carcinoma
- Keywords
- Breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Antisoma ResearchIndustry (pharma, biotech, devices)
- Study start
- Sep 2008
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 10 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: AS1402AS1402 plus letrozole |
| 2 | Active comparator | Drug: LetrozoleLetrozole |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AS1402Also: huHMFG1A 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). | Drug | 1 |
| LetrozoleAlso: FemaraDaily 2.5 mg oral letrozole tablet | Drug | 2 |
Primary outcome
The primary efficacy endpoint is overall response rate (ORR)
Time frame: Radiological evaluations are performed every 12 weeks up to progression
5 secondary outcomes
Progression-free survival (PFS)
Time frame: Radiological evaluations are performed every 12 weeks up to progression
Time to progression (TTP)
Time frame: Radiological evaluations are performed every 12 weeks up to progression
Duration of overall response and duration of stable disease
Time frame: Radiological evaluations are performed every 12 weeks up to progression
Clinical benefit rate (CBR)
Time frame: Radiological evaluations are performed every 12 weeks up to progression
Safety and tolerability of AS1402 when combined with letrozole
Time frame: Radiological evaluations are performed every 12 weeks up to progression
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2009.
- Derived from this study: PubMed 40443562Gorodetska 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.
- Derived from this study: PubMed 21878535Ibrahim 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.
Related trials for Breast Carcinoma
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Acton, MA MBBS MRCP study director
Antisoma Research
Nuhad K Ibrahim, MD FACP principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AS1402 and Letrozole in people with Breast Carcinoma, run by Antisoma Research at 2 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary efficacy endpoint is overall response rate (ORR) (time frame: Radiological evaluations are performed every 12 weeks up to progression). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00770354, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2009.